Karpschem Catalog 2024

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Our Focus Goes Beyond
Research Chemicals
Certified Pharmaceutical Contract Research Fully Characterized

Reference Standards Services Research Chemicals
www.karpschem.in | info@karpschm.in
www.karpschem.in | +91-7104295013
| info@karpschm.in | +91-7104295013 | |+91-9371639228
+91-9371639228
Our Focus Goes Beyond
Research Chemicals
Certified Pharmaceutical Contract Research Fully Characterized

Reference Standards Services Research Chemicals

Acyclovir
Acyclovir
ACY100 59277-89-3
2-Amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-3H-purin-6-one
Adenosine
Adenosine
ADN100 58-61-7
9-β-D-Ribofuranosyl-9H-purin-6-amine
Albendazole
Albendazole
ALB100 54965-21-8
Methyl 5-propylthio-2-benzimidazolecarbamate
Albendazole EP Impurity A
ALB201 80983-36-4
5-(Propylthio)-1H-benzimidazol-2-amine
Albendazole EP Impurity B
ALB202 54029-12-8 Methyl [5-(propylsulphinyl)-1Hbenzimidazol-2-yl]
carbamate
Albendazole EP Impurity C
ALB203 75184-71-3 Albendazole Sulfone ; Methyl [5-(propylsulphonyl)
-1Hbenzimidazol-2-yl]carbamate
Albendazole EP Impurity D
ALB204 80983-34-2
Desmethoxycarbonyl Albendazole Sulfone
ALB205 10605-21-7 Albendazole EP Impurity E
Alfuzosin
Alfuzosin HCl
ALF100 81403-68-1 (RS)-N-[3-[(4-Amino-6,7-dimethoxyquinazolin-2-yl)(methyl)amino]propyl]tetrahydrofuran-2-carboxamide
hydrochloride
Alfuzosin EP Impurity A
ALF201 98902-29-5
Alfuzosin USP Related Compound A ; Alfuzosin Tetradehydro Impurity
Alfuzosin EP Impurity B
ALF202 23680-84-4 2-chloro-6,7-dimethoxyquinazolin-4-amine ; 4-Amino-2-chloro-6,7-dimethoxyquinazoline ; 2-Chloro-6,7-
dimethoxy-4-quinazolinamine
Alfuzosin EP Impurity C
ALF203 72104-34-8 (RS)-N-[3-[(4-Amino-6,7-dimethoxyquinazolin-2-yl)amino]propyl]-N-methyltetrahydrofuran-2-carboxamide
hydrochloride
Alfuzosin EP Impurity D
ALF204 81403-69-2
Alfuzosin Aminopropyl Impurity ; Alfuzosin USP Related Compound D
Page 1
Alfuzosin EP Impurity E
ALF205 1026411-59-5
N-[3-[(4-Amino-6,7-dimethoxyquinazolin-2-yl)(methyl)amino]propyl]formamide hydrochloride
Alfuzosin EP Impurity F
ALF206 19216-53-6 6,7-dimethoxy-N2,N2-dimethylquinazoline-2,4-diamine ; 4-Amino-2-(dimethylamino)-6,7-dimethoxy-
quinazoline
Allopurinol
Allopurinol
ALP100 315-30-0
1,5-Dihydro-4H-pyrazolo[3,4-d]pyrimidin-4-one
Allopurinol EP Impurity A
ALP201 27511-79-1 Allopurinol USP RC A ; 5-amino-1H-pyrazole-4-carboxamide
Allopurinol EP Impurity B
ALP202 22407-20-1 Allopurinol USP RC B ; 5-(formylamino)-1H-pyrazole-4
-carboxamide
Allopurinol EP Impurity C
ALP203 1346604-13-4
Allopurinol USP RC C ; 5-(4H-1,2,4-triazol-4-yl)-1H-pyrazole-4 -carboxamide
Allopurinol EP Impurity D
ALP204 6994-25-8
Allopurinol USP RC D ; ethyl 5-amino-1H-pyrazole-4-carboxylate
31055-19-3 Allopurinol EP Impurity E

ALP205 Allopurinol USP RC E ;
ethyl 5-(formylamino)-1H-pyrazole-4-carboxylate
Alprazolam
Alprazolam
ALR100
28981-97-7 8-Chloro-1-methyl-6-phenyl-4H-[1,2,4]triazolo[4,3-a] [1,4]benzodiazepine
Alprazolam Impurity 1
ALR401 719-59-5
Prazepam Imp. C (EP), Clorazepate Imp. A (EP), , 2-Amino-5-chloro benzophenone
Althiazide
Althiazide
ALT100 5588-16-9
(3R)-3-[(Allylsulfanyl)methyl]-6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide
Althiazide Impurity 1
ALT401 1824-47-1
6-Chloro-3-(chloromethyl)-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-Dioxide
Amiodarone
Amiodarone
AMD100 19774-82-4
(2-Butyl-3-benzofuranyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl] methanone Hydrochloride
Amiodarone Impurity 1
AMD401 4265-27-4
2-Butyl Benzofuran
AMD402 NA
(2-butyl-1-benzofuran-3-yl)(2-methoxyphenyl)methanone
Page 2
AMD403 NA
(2-butyl-1-benzofuran-3-yl)(3-methoxyphenyl)methanone
Amitriptyline Hydrochloride
AMT100 549-18-8
3-(10,11-Dihydro-5H-dibenzo[a,d]cycloheptene-5-ylidene)-N,N-dimethylpropan-1-amine Hydrochloride
Amitriptyline EP Impurity A
AMT201 1210-35-1
Amitriptyline USP Related Compound A ; 10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-one
Amitriptyline EP Impurity B
AMT202 6202-23-9 Cyclobenzaprine HCl (USP) ; 3-(5H-Dibenzo[a,d][7]annulen-5-ylidene)-N,N-dimethylpropan-1-amine
hydrochloride
Amlodipine
Amlodipine
AML100 88150-47-4 3-ethyl 5-Methyl 2-((2-aMinoethoxy)Methyl)-4-(2-chlorophenyl)
-6-Methyl-1,4-dihydropyridine-3,5-dicarboxylate
Amlodipine EP impurity A
AML201 88150-62-3
Amlodipine USP RC D,Phthaloyl Amlodipine
Amlodipine EP impurity B
AML202 721958-72-1 Methylaminophthaloyl Amlodipine;
N-[2-[(Methylamino)carbonyl]benzoyl] Amlodipine
Amlodipine EP Impurity D
AML204 113994-41-5 3-ethyl 5-methyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methylpyridine-3,5-dicarboxylate
benzenesulfonate
Amlodipine EP Impurity E
Amlodipine Diethyl Ester;
AML205 140171-65-9
2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylic Acid 3,5-
Diethyl Ester
Amlodipine EP Impurity F
Amlodipine Dimethyl Ester;
AML206 140171-66-0
2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylic Acid 3,5-
dimethyl Ester
Amlodipine EP impurity G
AML207 43067-01-2 Dimethyl 4-(2-Chlorophenyl)-2,6-dimethyl-
1,4-dihydropyridine-3,5-dicarboxylate
Amlodipine EP Impurity H
AML208 318465-73-5
2-Carboxybenzoyl Amlodipine
Amlodipine USP RC A
AML301 2138811-33-1 (3-Ethyl 5-methyl [2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-3,5-pyridinedicarboxylate
fumarate)
Deschloro Amlodipine
AML401 88150-52-1 2-[(2-Aminoethoxy)methyl]-1,4-dihydro-6-methyl-4-phenyl-3,5-pyridinedicarboxylic Acid 3-Ethyl 5-Methyl
Ester
Hydroxyethyl Phthalyl Amlodipine

AML402 NA 3-ethyl 5-methyl 4-(2-chlorophenyl)-2-((2-(2-((2-hydroxyethyl)carbamoyl)benzamido)ethoxy)methyl)-6-
methyl-1,4-dihydropyridine-3,5-dicarboxylate
Page 3
Amoxicillin
Amoxicillin Trihydrate
AMX100 61336-70-7 (2S,5R,6R)-6-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl
-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate
Amoxicillin EP Impurity A
AMX201 551-16-6 Amoxicillin Related Compound A ; 6-APA ; (+)-6-Aminopenicillanic acid ;
(2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
Amoxicillin Trihydrate
AMX100 61336-70-7 (2S,5R,6R)-6-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl
-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate
Amoxicillin EP Impurity A
AMX201 551-16-6 Amoxicillin Related Compound A ; 6-APA ; (+)-6-Aminopenicillanic acid ;
(2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
Apixaban
Apixaban
APX100 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-
503612-47-3 3-carboxamide
Apixaban ethyl ester impuity/ Apixaban Impurity 1

APX401 503614-91-3 Ethyl 1-(4-Methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-
c]pyridine-3-carboxylate
Apixaban acid impuity/ Apixaban Impurity 2

APX402 503614-92-4 4,5,6,7-Tetrahydro-1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidinyl) phenyl]-1H-pyrazolo[3,4-c]pyridine-
3-carboxylic acid
Apixaban methyl ester impuity/ Apixaban Impurity 3

APX403 1074365-84-6 4,5,6,7-Tetrahydro-1-(4-hydroxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidinyl) phenyl]-1H-pyrazolo[3,4-c]pyridine-
3-carboxamide
O-Desmethyl Apixaban/ Apixaban Impurity 4

APX404 503612-76-8 4,5,6,7-Tetrahydro-1-(4-hydroxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidinyl) phenyl]-1H-pyrazolo[3,4-c]pyridine-
3-carboxamide
Apixaban chloro impurity / Apixaban Impurity 5

APX405 2029205-64-7 1-(4-chlorophenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-
carboxylic Acid Amide
Apixaban Amino Acid Impurity / Apixaban Impurity 6

APX406 2187409-01-2 6-(4-((5-amino-5-oxopentyl)amino)phenyl)-1-(4-methoxyphenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-
c]pyridine-3-carboxamide
Page 4
Apixaban morpholine lactum impurity / Apixaban Impurity 7
APX407 545445-44-1
3-Morpholino-1-(4-(2-oxopiperidin-1-yl)phenyl)-5,6-dihydropyridin-2(1H)-one
Apixaban Impurity 8
APX408 405872-78-8
ethyl (Z)-2-chloro-2-(2-(3-methoxyphenyl)hydrazono)acetate
Apixaban Impurity 9
APX409 536759-91-8 ethyl 1-(4-methoxyphenyl)-6-(4-nitrophenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-
carboxylate
Apixaban Impurity 10
APX410 503615-07-4 ethyl 6-(4-aminophenyl)-1-(4-methoxyphenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-
carboxylate
APX411 NA
3-morpholino-1-(4-(2-oxopiperidin-1-yl)phenyl)pyridin-2(1H)-one
4,5-Dehydro Apixaban/ Apixaban Impurity 12

APX412 1074549-89-5 1-(4-Methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-6,7-dihydro-1H-pyrazolo[3,4-c]pyridine-3-
carboxamide
6-(4-aminophenyl)-1-(4-methoxyphenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-
APX413 1423803-24-0
carboxamide;6-(4-aminophenyl)-1-(4-methoxyphenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-
carboxamide
7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-1-phenyl-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-
APX414 1801881-17-3
carboxamide;7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-1-phenyl-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-
3-carboxamide
1-(4-ethoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-
APX415 1928718-22-2
carboxamide;1-(4-ethoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-
c]pyridine-3-carboxamide
Apixaban IV Chloro Impurity

APX416 2029205-62-5 Ethyl 1-(4-chlorophenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-
c]pyridine-3-carboxylate
Apixaban Impurity 3(BMS-778960)

APX417 2098457-92-0 1-(4-Methoxyphenyl)-6-(4-(2-methyl-6-oxopiperidin-1-yl)phenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-
c]pyridine-3-carboxamide( Apixaban Impurity A)
Apixaban Open Chain Acid

APX418 2206825-87-6 5-[[4-[3-(Aminocarbonyl)-1,4,5,7-tetrahydro-1-(4-methoxyphenyl)-7-oxo-6H-pyrazolo[3,4-c]pyridin-6-
yl]phenyl]amino]pentanoic Acid
Apremilast
APR100 608141-41-9 (S)-N-(2-(1-(3-ethoxy-4-methoxyphenyl)
-2-(methylsulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide
Page 5
Apremilast
Apremilast Impurity 1
APR401 608141-42-0
(1S)-1-(3-Ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethylamine
ARG100 74-79-3 L-(+)-Arginine
ARG401 2645-08-1 BENZOYL ARGININE ETHYL ESTER
Aripiprazole
Aripiprazole
ARP100 129722-12-9
7-(4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one
Aripiprazole EP Impurity A
ARP201 22246-18-0
3,4-Dihydro-7-hydroxyquinoline-2(1H)-one
Aripiprazole EP Impurity B
ARP202 119532-26-2
1-(2,3-dichlorophenyl)piperazine ; 4-(2,3-Dichlorophenyl)-1-piperazinebutanol Hydrochloride;
Aripiprazole EP Impurity E
ARP205 129722-25-4 Aripiprazole related compound G ; Dehydro Aripiprazole Impurity, 7-(4-(4-(2,3-dichlorophenyl)piperazin-1-yl)
butoxy)quinolin-2(1H)-one,
Aripiprazole EP Impurity F
ARP206 573691-09-5
Aripiprazole Related Compound F
Aripiprazole Related Compound B

ARP302 889443-20-3
3,4-Dihydro-7-(4-hydroxybutoxy)-2(1H)-quinolinone
Aripiprazole Impurity 1
ARP401 120004-79-7
7-(4-Chlorobutoxy)-3,4-dihydro-2(1H)-quinolinone; 7-(4-Chlorobutoxy)-3,4-dihydro-C2(1H)-quinoline
Aripiprazole Impurity
ARP402 129722-34-5
2 7-(4-Bromobutoxy)-3,4-dihydroquinolin-2-one
ARP403 70500-72-0
7-Hydroxyquinoline-(1H)-2-one , 7-Hydroxy-2(1H)-quinolinone
ARP404 63386-61-8
Piperazine, 1-(2,6-dichlorophenyl)-; 1-(2,6-Dichlorophenyl)piperazine
ARP405 NA
N1-(2-chloroethyl)-N2-(2,3-dichlorophenyl)ethane-1,2-diamine hydrochloride
ARP406 952308-47-3
7-(4-iodobutoxy)-3,4-dihydroquinolin-2(1H)-one
Aspartame
Page 6
Aspartame
ASP100 22839-47-0
(S)-3-Amino-4-(((S)-1-methoxy-1-oxo-3-phenylpropan-2-yl)amino)-4-oxobutanoic acid
Aspartame EP Impurity B
ASP202 13433-09-5
(S)-3-Amino-4-(((S)-1-carboxy-2-phenylethyl)amino)-4-oxobutanoic acid
Aspartame EP Impurity C
ASP203 150-30-1
Phenylalanine
Aspartame Impurity 1
ASP401 123-30-8
Paracetamol EP Impurity K/ Mesalazine EP Impurity A
Atenolol
Atenolol
ATN100 29122-68-7 2-[4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino]
propoxy]phenyl]acetamide
Atenolol EP Impurity A
ATN201 17194-82-0
2-(4-Hydroxyphenyl)acetamide, Atenolol Related Compound A
Atenolol EP Impurity B
ATN202 61698-76-8
Atenolol Related Compound B, 2-[4-[(2RS)-2,3-dihydroxypropoxy]phenyl]acetamide
Atenolol EP Impurity C
ATN203 29122-69-8
2-[4-[[(2RS)-oxiran-2-yl]methoxy]phenyl]acetamide
Atenolol EP Impurity D
ATN204 115538-83-5
2-[4-[(2RS)-3-chloro-2-hydroxypropoxy]phenyl]acetamide
Atenolol EP Impurity E
ATN205 141650-31-9
Atenolol Related Compound E, 2,2'-[2-Hydroxypropan-1,3-diylbis(oxy-4,1-phenylene)]diacetamide
Atenolol EP Impurity F
ATN206 87619-83-8 Atenolol Related Compound F, 2,2'-[(1-Methylethyl)iminobis(2-hydroxypropan-3,1-diyloxy-4,1-
phenylene)]diacetamide
ATN207 56392-14-4 Atenolol EP Impurity G
Atenolol EP Impurity I
ATN209 1797116-92-7
2-(4-(3-(Ethylamino)-2-hydroxypropoxy)phenyl)acetamide
Atenolol EP Impurity J
ATN210 81346-71-6
2-(4-(3-amino-2-hydroxypropoxy)phenyl)acetamide
Atomoxetine Hydrochloride
ATM100 82248-59-7 Atomoxetine Hydrochloride

(R)-N-Methyl-(2-methylphenoxy)benzenepropanamine Hydrochloride
Atomoxetine EP Impurity A
ATM201 873310-33-9
N-methyl-3-phenoxy-3-phenylpropan-1-amine hydrochloride
Page 7
1643684-06-3 / Atomoxetine EP Impurity C
ATM203
1010818-96-8 Atomoxetine USP RC C ; p-Methyl Atomoxetine HCl
1643684-05-2/ Atomoxetine EP Impurity D

ATM204
1643684-02-9 Atomoxetine USP RC B ; m-Methyl Atomoxetine HCl
Atomoxetine EP Impurity E
ATM205 17199-29-0
L-Mandelic Acid ; (S)-(+)-Mandelic Acid ; (2S)-2-Hydroxy-2-phenylacetic acid
ATM208 42142-52-9 Atomoxetine EP Impurity H

Atomoxetine USP RC A ; 3-(Methylamino)-1-phenylpropan-1-ol
Atomoxetine Impurity 1
ATM401
(R)-1-Methyl-1-(3-phenyl-3-(o-tolyloxy)propyl)urea
Atorvastatin calcium salt

Atorvastatin calcium salt
Calcium (3R,5R)-7-[2-(4-fluorophenyl)-5
ATR100 134523-03-8
-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]
-3,5-dihydroxyheptanoate
Atorvastatin EP Impurity F
ATR206 887196-24-9 (3R,5R)-7-[[(3R,5R)-7-[2-(4-fluorophenyl)-5-(1-methylethyl)
-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoyl]amino]-3,5-dihydroxyheptanoic acid
Atorvastatin EP Impurity N/ Atorvastatin Acid t-Butyl Ester

(3R,5R)-7-[3-(Phenylcarbamoyl)-5-(4-fluorophenyl)
ATR214 134395-00-9
-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid
t-butyl ester
Atorvastatin Impurity 2/ Atorvastatin Acid Methyl Ester

(3R,5R)-7-[3-(Phenylcarbamoyl)-5-(4-fluorophenyl)
ATR401 345891-62-5
-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5
-dihydroxyheptanoic acid methyl ester
Atropine Sulfate
Atropine Sulfate
ATP100 5908-99-6
Atropine Sulfate Monohydrate
Atropine EP Impurity A
ATP201 500-55-0
Apoatropine, 8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-phenylacrylate
Atropine EP Impurity B
ATP202 16839-98-8
(1R,3r,5S)-8-azabicyclo[3.2.1]octan-3-yl 3-hydroxy-2-phenylpropanoate
Atropine EP Impurity C
ATP203 552-63-6
Tropic acid, 2-Phenylhydracrylic acid, 3-Hydroxy-2-phenylpropionic acid
Page 8
Atropine Impurity 1
ATP401 14510-36-2
3-acetoxy-2-phenylpropanoic acid
Atropine Impurity 2
ATP402
( 1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 3-acetoxy-2-phenylpropanoate
Atropine Impurity 3
ATP403 120-29-6
Tropine, (1R,3r,5S)-8-Methyl-8-azabicyclo[3.2.1]octan-3-ol
Azilsartan
863031-24-7 Azilsartan medoxomil potassium
AZL100
863031-21-4 Azilsartan medoxomil potassium
Azilsartan
AZL101 147403-03-0 1-[[2’-(2,5-Dihydro-5-oxo-1,2,4-oxadiazol-3-yl)
[1,1’-biphenyl]-4-yl]methyl]-2-ethoxy-1H-benzimidazole-7-carboxylic Acid
Azilsartan Impurity A/ Azilsartan Impurity 1

AZL401 147404-76-0 methyl 1-((2'-carbamoyl-[1,1'-biphenyl]-4-yl)methyl)
-2-ethoxy-1H-benzo[d]imidazole-7-carboxylate
Azilsartan Impurity B/ Azilsartan Impurity 2

AZL402 1696392-11-6 1-((2'-carbamoyl-[1,1'-biphenyl]-4-yl)methyl)
-2-ethoxy-1H-benzo[d]imidazole-7-carboxylic acid
Azilsartan Impurity C/ Azilsartan Impurity 3
AZL403 397836-49-5 2-ethoxy-1-((2'-(N'-hydroxycarbamimidoyl)
-[1,1'-biphenyl]-4-yl)methyl)-1H-benzo[d]imidazole-7-carboxylic acid
Azilsartan Impurity D/ Azilsartan Impurity 4

AZL404 1821386-21-3 3-((2'-(N'-hydroxycarbamimidoyl)-[1,1'-biphenyl]-4-yl)
methyl)-2-oxo-2,3-dihydro-1H-benzo[d]imidazole-4-carboxylic acid
Azilsartan Impurity M/ Azilsartan Impurity 13

AZL413 632322-61-3 1-((2'-cyano-[1,1'-biphenyl]-4-yl)methyl)
-2-ethoxy-1H-benzo[d]imidazole-7-carboxylic acid
Azilsartan Ethyl Impurity/ Azilsartan Impurity 14

AZL414 1403474-70-3 ethyl 2-ethoxy-1-((2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)-[1,1'-biphenyl]-4-yl)methyl)-1H-
benzo[d]imidazole-7-carboxylate
Azilsartan Ethyl Ring-opening Impurity/ Azilsartan Impurity 15

AZL415 1403474-75-8 ethyl (Z)-2-ethoxy-1-((2'-(N'-((ethoxycarbonyl)oxy)carbamimidoyl)
-[1,1'-biphenyl]-4-yl)methyl)-1H-benzo[d]imidazole-7-carboxylate
Azilsartan Impurity 16
AZL416 139481-44-0 methyl 1-((2'-cyano-[1,1'-biphenyl]-4-yl)methyl)
-2-ethoxy-1H-benzo[d]imidazole-7-carboxylate
Azilsartan Impurity 17
AZL417 147403-52-9 Azilsartan Methyl Ester ; methyl 2-ethoxy-1-((2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)-[1,1'-biphenyl]-4-
yl)methyl)-1H-benzo[d]imidazole-7-carboxylate
Page 9
Azithromycin
AZT100 117772-70-0 Azithromycin Dihydrate
Azithromycin EP Impurity A, AZAERYTHROMYCIN A

AZT201 76801-85-9
9-Deoxo-9a-aza-9a-homoerythromycin A; 6-Demethylazithromycin
Azithromycin EP Impurity F
AZT206 612069-28-0
Azithromycin USP Related Compound F, 3′-N-Demethyl-3′-N-formylazithromycin
Azithromycin EP Impurity I
AZT209 172617-84-4
N'-Desmethyl Azithromycin; N-Demethylazithromycin
Azithromycin EP Impurity J
AZT210 117693-41-1
Desosaminylazithromycin (USP) ; Descladinose Azithromycin
Azithromycin EP Impurity L
AZT212
Azithromycin N-Oxide
Beclometason
Beclometasone Dipropionate
BCL100 [2-[(8S,9R,10S,11S,13S,14S,16S,17R)-9-chloro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-
6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] propanoate
BNZ100 255-18-5 2H-1,2,4-Benzothiadiazine
Benzothiadiazine Related Compound A

BNZ301 121-30-2
4-Amino-6-chloro-1,3-benzenedisulfonamide
β-Carotene
β-Carotene
CRT100 7235-40-7 1,3,3-Trimethyl-2-[3,7,12,16-tetramethyl-18-(2,6,6-trimethylcyclohex-1-en-1-yl)
octadeca-1,3,5,7,9,11,13,15,17-nonaen-1-yl]cyclohex-1-ene
Betahistine Impurity A
BTH201 100-69-6
2-Vinylpyridine (stabilized with 4-tert-butylpyrocatechol)
Betahistine/ Betahistine HCl

BTH100 5638-76-6/5579-84-0 N-Methyl-2-pyridineethanamine; 2-[2-(Methylamino)ethyl]pyridine;
2-[2-(Methylamino)ethyl]pyridine
Betahistine EP Impurity A
BTH201 100-69-6
2-Vinylpyridine
Page 10
Betahistine EP Impurity C
BTH203 2095467-43-7/5452-87-9
Benzothiadiazine, N-Methyl-2-(pyridin-2-yl)-N-(2-(pyridin-2-yl)ethyl)ethan-1-amine trihydrochloride
Betahistine Impurity B
BTH401 103-74-2
2-Pyridineethanol
Bilastine
Bilastine
BLS100 202189-78-4
2-[4-(2-{4-[1-(2-Ethoxyethyl)-1H-benzimidazol-2-yl]-1-piperidinyl}ethyl)phenyl]-2-methylpropanoic acid
Bilastine impurity I
BLS401 1181267-33-3
Methyl 2-(4-(2-chloroethyl)phenyl)-2-methylpropanoate
BISOPROLOL HEMIFUMARATE
BSP100 104344-23-2 / 66722-44-9 1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]
-3-[(1-methylethyl)amino]-2-propanol, Bisoprolol Fumarate
Bisoprolol EP Impurity K
BSP211 864544-37-6
2-isopropoxyethyl 4-(2-hydroxy-3-(isopropylamino)propoxy)benzoate
Bisoprolol EP Impurity L
BSP212 29122-74-5
4-[((2RS)-2-Hydroxy-3-(isopropylamino)-propyl)oxy]benzaldehyde
Bisoprolol EP Impurity N
BSP214 1346601-75-9
(2RS)-1-[4-((2-Ethoxyethoxy)methyl)phenoxy]-3-(isopropylamino)-2-propanol
Bisoprolol EP Impurity Q
BSP217 1346604-00-9
(2RS)-1-Isopropylamino-3-[4-(2-methoxyethoxy)methyl]-phenoxy-2-propanol
Bisoprolol Carboxylic Acid Impurity

BSP401 72570-70-8
4-(2-Hydroxy-3-isopropylaminopropoxy)benzoic Acid
Brexpiprazole
Brexpiprazole
BRX100 913611-97-9
7-[4-(4-Benzo[b]thien-4-yl-1-piperazinyl)butoxy]-2(1H)-quinolinone
Brexpiprazole Impurity 1
BRX401 1420987-86-5
1,4-bis(benzo[b]thiophen-4-yl)piperazine
Brexpiprazole N-Oxide
7-[4-(4-Benzo[b]thien-4-yl-1-oxido-1-piperazinyl)butoxy]
BRX402 1191900-58-9
-2(1H)-quinolinone
BRX403 31570-97-5
5-hydroxy-; 5-Hydroxy-2(1H)-quinolinone
BRX404 1886188-97-1
7-(4-hydroxybutoxy)quinolin-2(1H)-one
BRX405 2116542-19-7
7,7'-(butane-1,4-diylbis(oxy))bis(quinolin-2(1H)-one)
Page 11
BRX406 2138169-93-2 Brexpiprazole Impurity 31
2,7-bis(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)quinoline
BRX407 2137823-20-0 7-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)-1-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-
yl)butyl)quinolin-2(1H)-one
BRX408 913612-07-4 7-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)
-3,4-dihydroquinolin-2(1H)-one
BRX409 2059954-32-2
7-(4-chlorobutoxy)-1-(4-chlorobutyl)quinolin-2(1H)-one
BRX410 2060027-95-2
2,7-bis(4-chlorobutoxy)quinoline
BRX411 913614-18-3
1-(benzo[b]thiophen-4-yl)piperazine hydrochloride
BRX412 1849603-58-2
7-(4-(piperzin-1-yl)butoxy)quinolin-2(1H)-one
BRX413 5118-13-8
4-Bromo benzo[b]thiophene
Brexpiprazole Di-N-Oxide
BRX414 2247155-42-4 1-(Benzo[b]thiophen-4-yl)-4-(4-((2-oxo-l,2-dihydroquinolin-7-yl)
oxy)butyl) piperazine 1,4-dioxide
BRX415 913613-82-8
7-(4-chloro butoxy)-1H-quinolin-2-one
BRX416 203395-59-9
7-(4-Bromobutoxy)-quinoline-2(1H)-one
BRX417 2094559-58-5 7-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)-1-
(4-((2-oxo-1,2-dihydroquinolin-7-yl)oxy)butyl)quinolin-2(1H)-one
Brexpiprazole S-Oxide
BRX418 1191900-51-2
7-[4-[4-(1-Oxidobenzo[b]thien-4-yl)-1-piperazinyl]butoxy]-2(1H)-quinolinone
4-Chlorobenzo[b]thiophene
BRX501 66490-33-3
4-Chlorobenzo[b]thiophene
Brimonidine
Brimonidine
BRM100 59803-98-4
5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-6-quinoxalinamine
Brimonidine EP Impurity A
BRM201 91147-43-2 Desbromo Brimonidine ;
N-(Imidazolidin-2-ylidene)quinoxalin-6-amine
Brimonidine EP Impurity C
BRM203 6298-37-9
Quinoxalin-6-amine
Brompheniramine Maleate
BRP100 980-71-2
(3RS)-3-(4-Bromophenyl)-N,N-dimethyl-3-(pyridin-2-yl)propan-1-amine (Z)-butenedioate
Page 12
Brompheniramine Maleate EP Impurity A
BRP201 132-22-9
Chlorphenamine
Brompheniramine Maleate EP Impurity C

BRP203 86-21-5
pheniramine
Brompheniramine impurity 1
BRP401 65676-22-4
2-(4-bromophenyl)-4-(dimethylamino)-2-(pyridin-2-yl)butanenitrile
Brompheniramine impurity 2
BRP402 85750-24-9
(4-bromophenyl)(Pyridin-2-yl)acetonitrile
Desmethylbrompheniramine HCl
BRP403
(3RS)-3-(4-Bromo-phenyl)-N-methyl-3-(pyridin-2-yl) propan-1-amine HCl salt
Bumetanide
Bumetanide
BMT100 28395-03-1
3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid
Bumetanide EP Impurity A
BMT201 28328-53-2 Bumetanide Related Compound B ;
3-nitro-4-phenoxy-5-sulfamoylbenzoic acid
Bumetanide EP Impurity B
BMT202 28328-54-3 Bumetanide Related Compound A ;
3-amino-4-phenoxy-5-sulfamoylbenzoic acid ; Desbutyl Bumetanide
Bumetanide EP Impurity C
BMT203 32643-00-8
butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate
Bumetanide EP Impurity D
BMT204 153012-65-8
3-((2-ethylhexyl)amino)-4-phenoxy-5-sulfamoylbenzoic acid
Bumetanide Impurity -5
BMT401 57939-04-5
Methyl 3-nitro-4-phenoxy-5-sulfamoylbenzoate
Bupivacaine HCl
BPV100 18010-40-7 (2RS)-1-Butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide
hydrochloride
Bupivacaine EP Impurity A
BPV201 39627-98-0
N-(2,6-Dimethylphenyl)pyridine-2-carboxamide
Bupivacaine EP Impurity B
BPV202 15883-20-2
(2RS)-N-(2,6-Dimethylphenyl)piperidine-2-carboxamide
Bupivacaine EP Impurity C
BPV203 1797894-80-4
1-(2,6-Dimethylphenyl)-1,5,6,7-tetrahydro-2H-azepin-2-one
Bupivacaine EP Impurity D
BPV204 1037184-07-8
(2RS)-2,6-Dichloro-N-(2,6-dimethylphenyl)hexanamide
Page 13
Bupivacaine EP Impurity E
BPV205 1330172-81-0
6-(Butylamino)-N-(2,6-dimethylphenyl)hexanamide
87-62-7 / Bupivacaine EP Impurity F

BPV206
21436-98-6 2,6-Dimethylaniline/ ROPIVACAINE RELATED COMPOUND A
Picolonic acid
BPV501 98-98-6
Pyridine-2-carboxylic Acid
Bupropion
Bupropion Hydrochloride
BPR100 31677-93-7
2-(t-Butylamino)-3'-chloropropiophenone hydrochloride
Bupropion Related Compound A

BPR301 1049718-72-0/ 252193-58-1
2-(Tert-Butylamino)-4’-chloropropiophenone Hydrochloride
Bupropion Related Compound B

BPR302 1049718-43-5
2-(Tert-Butylamino)-3′-bromopropiophenone hydrochloride
Bupropion USP Related Compound C

BPR303 152943-33-4
1-(3-chlorophenyl)-2-hydroxypropan-1-one
Bupropion Related Compound D

BPR304 63199-74-6
2-(Tert-Butylamino)propiophenone Hydrochloride, Deschloro Bupropion Hydrochloride
Bupropion Related Compound E

BPR305 10557-17-2
Bupropion dione derivative
Bupropion Related Compound F

BPR306 857233-13-7
1-(3-Chlorophenyl)-1-hydroxypropan-2-one
Bupropion 2-Bromo Impurity

BPR401 34911-51-8
Bupropion Related Compound G, 2-Bromo-1-(3-chlorophenyl)-1-propanone
Bupropion Des-t-Butylamino Impurity

BPR402 34841-35-5
3'-Chloropropiophenone , 1-(3-Chlorophenyl)-1-propanone
Bupropion Impurity 1
BPR403 92821-92-6
3,5 Dichloropropiophenone
Bupropion Nitroso Impurity

BPR404 NA
N-(Tert-butyl)-N-(1-(3-chlorophenyl)-1-oxopropan-2-yl)nitrous amide
Buspirone
Buspirone Hydrochloride
BSR100 33386-08-2 8-[4-[4-(Pyrimidin-2-yl)piperazin-1-yl]butyl]
-8-azaspiro[4.5]-decane-7,9-dione hydrochloride
Buspirone EP Impurity A
BSR201 20980-22-7
Buspirone USP RC A; 2-(Piperazin-1-yl)pyrimidine
Buspirone EP Impurity B
BSR202 81461-73-6
Buspirone Spiroammonium Salt Impurity (USP)
Page 14
Buspirone EP Impurity G
BSR207 84746-24-7
Buspirone USP Related Compound G, 2,2′-(Piperazine-1,4-diyl)dipyrimidine
Buspirone EP Impurity K
BSR211 1075-89-4
Buspirone USP Related Compound K; 8-Azaspiro[4.5]decane-7,9-dione
Buspirone EP Impurity L
BSR212 21098-11-3
Buspirone USP Related Compound L, 8-(4-Chlorobutyl)-8-azaspiro[4.5]decane-7,9-dione
Buspirone EP Impurity M
BSR213 80827-62-9
Buspirone Bromobutyl Impurity, 8-(4-Bromobutyl)-8-azaspiro[4.5]decane-7,9-dione
Buspirone EP Impurity N
BSR214 257877-44-4
Buspirone USP Related Compound N, 8,8′-(Butane-1,4-diyl)bis(8-azaspiro[4.5]decane-7,9-dione)
Busulfan
Busulfan
BSL100 55-98-1
1,4-Butanediol-dimethanesulfonate Esters; Busulphan
Candesartan
Candesartan Cilexetil
CND100 145040-37-5 1-[[(Cyclohexyloxy)carbonyl]oxy]ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-
benzimidazole-7-carboxylate
Candesartan EP Impurity A
CND201 139481-58-6 Candesartan Ethyl Ester ; 2-Ethoxy-1-[[2-[1-(triphenylmethyl)
-1H-tetrazol-5-yl][1,1?-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylic Acid ethyl ester
Candesartan Bromo N1-Trityl Impurity

CND401 124750-51-2
5-(4'-Bromomethyl-1,1'-biphenyl-2-yl)-1-triphenylmethyl-1H-tetrazole
Carbamazepine
Carbamazepine
CRB100 298-46-4
5H-Dibenzo[b,f]azepine-5-carboxamide
Carbamazepine EP Impurity A
CRB201 3564-73-6
Carbamazepine USP Related Compound A
Carbamazepine EP Impurity B
CRB202 611-64-3
9-Methylacridine
Carbamazepine EP Impurity D
CRB204 256-96-2
Carbamazepine Related Compound B, 5H-Dibenzo[b,f]azepine
Carbamazepine EP Impurity E
CRB205 494-19-9
10,11-dihydro-5H-dibenzo[b,f]azepine (iminodibenzyl),
Carbamazepine EP Impurity F
CRB206 33948-22-0
H-dibenzo[b,f]azepine-5-carbonyl chloride
Page 15
Carvone
CRV100 99-49-0 Carvone
Cefadroxil
Cefadroxil Monohydrate
CFD100 66592-87-8 (6R,7R)-7-[[(2R)-Amino-(4-hydroxyphenyl)acetyl]amino]-3-methyl-
8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Monohydrate
Cefadroxil EP Impurity B/
CFD401 22252-43-3 7-AMINODESACETOXYCEPHALOSPORANIC ACID 6R,7R)-7-Amino-3-methyl-8-oxo-5-thia-1-azabicyclo
[4.2.0]oct-2-ene-2-carboxylic Acid
Celecoxib
Celecoxib
CLX100 169590-42-5 4-[5-(4-Methylphenyl)-3-trifluoromethyl-1H-pyrazol-1-yl]
benzenesulfonamide
Celecoxib EP Impurity A
CLX201 170570-01-1 USP Related Compound A ; Celecoxib 3-Methyl Analog;4-[5-(3-Methylphenyl)-3-trifluoromethyl-1H-pyrazol-1-
yl]benzenesulfonamide
Celecoxib EP Impurity B
CLX202 331943-04-5
USP Related compound B ; 4-[3-(4-Methylphenyl)-5-trifluoromethyl-1H-pyrazol-1-yl]benzenesulfonamide
Celecoxib 2-Methyl Analog

CLX401 170569-99-0
4-[5-(2-Methylphenyl)-3-trifluoromethyl-1H-pyrazol-1-yl]benzenesulfonamide
Celecoxib Hydrazine Impurity

CLX402 17852-52-7
4-Sulphonamido phenyl hydrazine hydrochloride
Celecoxib related compound D

CLX403 1061214-06-9
(E)-4-(2-(1-p-tolylethylidene)hydrazinyl)benzenesulfonamide
948293-46-7/ Celecoxib Impurity 2

CLX404 Celecoxib Impurity 6
219986-64-8
3-(p-tolyl)-5-(trifluoromethyl)-1H-pyrazole
Celecoxib Related Compound 4
CLX405 720-94-5
4,4,4-trifluoro-1-p-tolylbutane-1,3-dione
Celecoxib Impurity 7
CLX406 163266-02-2
4,4,4-trifluoro-1-(o-tolyl)butane-1,3-dione
Celecoxib Related Compound C

CLX407 170570-09-9 2,4-Dimethyl Celecoxib Impurity 4-[5-(2,4-Dimethylphenyl)-3-(trifluoromethyl)
-1H-pyrazol-1-yl]benzenesulfonamide
3-Methylacetophenone
CLX408 585-74-0
3-Methylacetophenone
CLX409 122-00-9 4-Methylacetophenone
Page 16
Celecoxib Impurity 3
CLX410 170569-87-6
4-(5-phenyl-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide
Cetirizine
Cetirizine Dihydrochloride
CTR100 83881-52-1 (RS)-2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]
ethoxy]acetic acid dihydrochloride
Cetirizine EP Impurity A
CTR201 303-26-4 Cetirizine CBHP Impurity (USP)
(RS)-1-[(4-Chlorophenyl)phenylmethyl]piperazine
Cetirizine EP Impurity B
CTR202 113740-61-7 (RS)-2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]
acetic acid dihydrochloride
Cetirizine EP Impurity C
CTR203 83881-59-8
Cetirizine 2-Chloro Analog (RS)-2-[2-[4-[(2-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy] acetic acid
346451-15-8 (base) Cetirizine EP Impurity D

CTR204 Cetirizine Dimer Impurity (USP)
856841-95-7 (2HCl)
; 1,4-bis[(4-Chlorophenyl)phenylmethyl]piperazine dihydrochloride
Cetirizine EP Impurity E
CTR205 682323-77-9
(RS)-2-[2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy] ethoxy] acetic acid
Cetirizine EP Impurity F
CTR206 83881-53-2
2-(2-(4-benzhydrylpiperazin-1-yl)ethoxy)acetic acid
Cetirizine EP Impurity G
CTR207 164726-80-1
Cetirizine Ethanol Impurity ; 2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethanol Dihydrochloride
Cetirizne Related Compound A

CTR301 246870-46-2 (base) Cetirizine Dihydrochloride Ethyl Ester ; (RS)-2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-
yl]ethoxy]acetic acid ethyl ester
Cetirizne Related Compound B

CTR302 108983-83-1
Cetirizine Deschloro Ethanol Impurity ; 2-[4-(Diphenylmethyl)piperazin-1-yl]ethanol dihydrochloride
200707-85-3 (HCl salt) Cetirizne Related Compound C

CTR303
83881-37-2 (base) Cetirizine Amide Impurity ; (RS)-2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetamide
Cetirizine Methyl Ester (USP)

CTR401 83881-46-3
(RS)-2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid methyl ester dihydrochloride
Cetirizine EP Impurity Ethyl Ester
CTR402 19178-83-7 (RS)-2-[4-[(4-Chlorophenyl)phenylmethyl]
piperazin-1-yl]acetic acid ethyl ester
Cetirizine 4-Chlorobenzhydrol Impurity
CTR403 119-56-2
Meclizine USP RC A ; 4-Chlorobenzhydrol
Cetirizine 4-Chlorobenzophenone Impurity (USP)

CTR404 134-85-0
(4-Chlorophenyl)phenylmethanone
Page 17
Cetirizine N-Oxide
CTR405 1076199-80-8 (RS)-2-[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-oxido-piperazin-1-yl]
ethoxy] acetic acid
1232460-29-5 | Cetirizine 3-Chloro Impurity

CTR406 3-Chloro Cetirizine Dihydrochloride (USP) ; (RS)-2-[2-[4-[(3-Chlorophenyl)phenylmethyl]piperazin-1-
1232460-31-9
yl]ethoxy] acetic acid
Chlorobenzhydryl Piperazine
CTR407 300543-56-0
(-)-1-[(4-Chlorophenyl)phenylmethyl]piperazine; (R)-1-(p-Chlorobenzhydryl)piperazine;
Cetirizine Ethyl Ester

CTR408 246870-46-2 Cetirizine Dihydrochloride Ethyl Ester ; (RS)-2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-
yl]ethoxy]acetic acid ethyl ester
3-Chlorobenzophenone
CTR409 1016-78-0
3-Chlorobenzophenone
1-Benzhydrylpiperazine
CTR410 841-77-0
1-Benzhydrylpiperazine
2-Chloro BHP Cetirizine

CTR411 109036-15-9
1-[(2-Chlorophenyl)phenylmethyl]piperazine
3-Chloro BHP Cetirizine

CTR412 NA
1-[(3-Chlorophenyl)phenylmethyl]piperazine
Chlordiazepoxide
Chlordiazepoxide
CHD100 58-25-3
7-chloro-2-(methylamino)-5-phenyl-3H-benzo[e][1,4]diazepine 4-oxide
Chlordiazepoxide EP Impurity A
CHD201 963-39-3 Chlordiazepoxide Related Compound A (7-Chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one 4-
Oxide)
Chlordiazepoxide EP Impurity C
CHD203 719-59-5
2-Amino-5-chlorophenyl)phenylmethanone
Chloroquine
Chloroquine
CHR100 54-05-7
7-Chloro-4-[[4-(diethylamino)-1-methylbutyl]amino]quinoline
Hydroxynovaldiamine
CHR401 69559-11-1
2-[(4-aminopentyl)(ethyl)amino]ethan-1-ol
Chlorphenamine
Chlorphenamine Maleate
CHP100 113-92-8
3-(4-chlorophenyl)-N,N-dimethyl-3-(pyridin-2-yl)propan-1-amine maleate
Page 18
Chlorphenamine EP Impurity A
CHP201 1246816-57-8
2-(4-chlorophenyl)-4-(dimethylamino)-2-(2-(dimethylamino)ethyl)butanenitrile
Chlorphenamine EP Impurity B
CHP202 1202-34-2
Chlorphenamine Related Compound B ; 3-(4-chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine
Chlorphenamine EP Impurity C
CHP203 20619-12-9 CHLORPHENIRAMINE RELATED COMPOUND C/
3RS)-3-(4-chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine
Chlorphenamine EP Impurity D
CHP204 65676-21-3/2575516-46-8
2-(4-chlorophenyl)-4-(dimethylamino)-2-(pyridin-2-yl)butanenitrile
Chlorphenamine N-Oxide
CHP401 120244-82-8
3-(4-chlorophenyl)-N,N-dimethyl-3-(pyridin-2-yl)propan-1-amine oxide
Chlorphenamine Impurity 1
CHP402 4584-46-7
2-chloro-N,N-dimethylethan-1-amine hydrochloride
Didesmethyl chlorpheniramine
CHP403 23052-94-0
3-(4-chlorophenyl)-3-(pyridin-2-yl)propan-1-amine
CHP404 4350-41-8
2-(4-Chlorobenzyl)pyridine, 2-(4-chlorobenzyl)pyridine
CHP405 5005-37-8
(4-chlorophenyl)(pyridin-2-yl)acetonitrile
Chlorthalidone
Chlortalidone
CHL100 77-36-1
2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide
Chlortalidone EP impurity A
CHL201 345930-32-7
Chlorthalidone Chlorosulfobenzoyl Benzoic Acid Impurity
Chlortalidone EP impurity B
CHL202 5270-74-6 Chlorthalidone USP RC A ; Chlorthalidone Acid ;
2-[3-(Aminosulfonyl)-4-chlorobenzoyl]-benzonic acid
Chlortalidone EP impurity C
CHL203 92874-73-2 Chlorthalidone Acid Ethyl Ester ; 2-[3-(Aminosulfonyl)-4-chlorobenzoyl]
-benzonic acid ethyl ester
Chlortalidone EP impurity D
CHL204 1369995-36-7 Chlorthalidone Ethyl Ether ; O-Ethyl Chlorthalidone ;
2-Chloro-5[(1RS)-1-ethoxy-3-oxo-2,3-dihydro-1H-isoindol-1-yl]benzene sulfonamide
Chlortalidone EP impurity E
CHL205 82875-49-8
Chlorthalidone Deshydroxy Impurity ; 2-Chloro-5-(3-oxo-1-isoindolinyl)benzenesulfonamide
Chlortalidone EP impurity G
CHL207 16289-13-7 Chlorthalidone Dichloro Impurity ;
(3RS)-3-(3,4-Dichlorophenyl)-3hydroxy-2,3-dihydro-1H-isoindol-1-one
Page 19
Chlortalidone EP impurity H
CHL208 NA Chlorthalidone Isopropyl Ether ;2-Chloro-5[(1RS)-1-(1-methylethoxy)-3-oxo-2,3-dihydro-1H-isoindol-1-yl]
benzenesulfonamide
Chlortalidone EP impurity I
CHL209 NA
Chlorthalidone Acid Isopropyl Ester ; 2-[3-(Aminosulfonyl)-4-chlorobenzoyl]-benzonic acid isopropyl ester
Chlortalidone Impurity J
CHL210 956-92-3
3-(4-chlorophenyl)-3-hydroxyisoindolin-1-one
Chlortalidone Methyl Ether
CHL401 6512-76-4 O-Methyl Chlortalidone ; 2-Chloro-5[(1RS)-1-methoxy-3-oxo-2,3-dihydro-1H-isoindol-1-yl]benzene
sulfonamide
Chlorthalidone acid methyl ester impurity
CHL402 92433-89-1
Methyl 2-(4-chloro-3-sulfamoylbenzoyl)benzoatey
Chloro Intermedate
CHL501 NA
2-chloro-5-(1-oxoisoindolin-3-yl)benzene-1-sulfonyl chloride
3-(4-Chlorophenyl)-1-isoindolinone
CHL502 2224-77-3 3-(p-Chlorophenyl)-phthalimidine; 3-(4-Chlorophenyl)isoindolinone; 3-(4-Chlorophenyl)-2,3-dihydro-1H-
isoindol-1-one
4-(4-Chlorophenyl)-1H-2,3-benzoxazin-1-one
CHL503 2224-83-1
4-(4-Chlorophenyl)-1H-2,3-benzoxazin-1-one
Chlorzoxazone
Chlorzoxazone
CHZ100 95-25-0
5-Chloro-2-benzoxazolinone;5-Chloro-2-hydroxybenzoxazole
Chlorzoxazone Related Compound A

CHZ301 95-85-2
2-Amino-4-chlorophenol
CHZ401 106-48-9 4-Chlorophenol
Cinacalcet
CNT100 364782-34-3 Cinacalcet HCl
Cinacalcet Impurity A
CNT401 3886-70-2/82572-04-1
(R)-(+)-1-(1-Naphthyl)ethylamine
Cinacalcet Impurity 1
CNT402 779-89-5
3-(3-(Trifluoromethyl)phenyl)acrylic acid
Cinacalcet Impurity 2
CNT403 1005450-55-4
R-N-(1-(naphthalen-1-yl)ethyl)-3-(3-(trifluoromethyl)phenyl)propanamide
Ciprofloxacin
Ciprofloxacin
CPR100 85721-33-1
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic Acid
Page 20
Ciprofloxacin Hydrochloride Monohydrate
CPR101 86393-32-0 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic Acid Hydrochloride; Bay
Q3939 Hydrochloride Monohydrate
Ciprofloxacin EP Impurity A
CPR201 86393-33-1 7-Chloro-1-cyclopropyl-6-fluoro-3-carboxy-1,4-dihydro-4-oxoquinoline;
Fluoroquinolonic Acid
Ciprofloxacin EP Impurity C
CPR203 103222-12-4/528851-31-2
Ciprofloxacin Ethylenediamine USP
Clarithromycin
Clarithromycin
CLR100 81103-11-9
6-O-Methylerythromycin; 6-O-Methylerythromycin A
Clonazepam
Clonazepam EP Impurity A
CLZ201 2011-66-7
Clonazepam USP Related Compound B
Clonidine
Clonidine
CLN100 4205-90-7
2,6-Dichloro-N-(imidazolidin-2-ylidene)aniline
Clonidine EP Impurity A
CLN201 5391-39-9
1-Acetylimidazolidin-2-one
Clonidine EP Impurity B
CLN202 54707-71-0
Clonidine Related Compound A ; 1-(2-((2,6-dichlorophenyl)amino)-4,5-dihydro-1H-imidazol-1-yl)ethan-1-one
Clonidine EP Impurity C
CLN203 608-31-1
2,6-Dichloroaniline
Clonidine Impurity B( Inhouse)

CLN401 14034-59-4
ethylene diamine mono-p-toluenesulfonic acid salt
Clopidogrel
Clopidogrel
113665-84-2/ S-(+)-Clopidogrel Hydrogen Sulfate
CLP100
120202-66-6 Methyl (2S)-(2-chlorophenyl)[6,7-dihydro thieno [3,2-c]pyridin-5(4H)-yl]
acetate
135046-48-9 CHLOPIDOGREL HYDROGEN SULPHATE RACEMATE
CLP101 90055-48-4 (Â±)-Methyl 2-(2-Chlorophenyl)-2-(6,7-dihydro-4H-thieno
[3,2-c]pyridin-5-yl)acetate Hydrogen Sulfate
Closantel
Page 21
Closantel
CLS100 57808-65-8 N-[5-chloor-4-[(4-chloorfenyl)-cyanomethyl]-2-methylfenyl]-2-hydroxy-3,5
-di-joodbenzamide
Closantel EP Impurity A
CLS201 133-91-5
2-Hydroxy-3,5-diiodobenzoic acid
Closantel EP Impurity B
CLS202 61437-85-2
(2RS)-(4-Amino-2-chloro-5-methylphenyl)(4-chlorophenyl)ethanenitril
Closantel EP Impurity C
CLS203 NA
(2RS)-[2-Chloro-4-[(2-hydroxy-3,5-diiodobenzoyl)amino]-5-methylphenyl](4-chlorophenyl)acetic acid
Closantel EP Impurity D
CLS204 NA N-[4-[(1RS)-2-amino-1-(4-chlorophenyl)-2-oxoethyl]-5-chloro-2-methylphenyl]-2-hydroxy-3,5-
diiodobenzamide
Dabigatran
Dabigatran Impurity 3
DBG403 211915-84-3
Dabigatran Ethyl Ester Cyano Analog
DBG409 1304574-20-6
Dabigatran Etexilate Propanoate
DBG410 NA hexyl (Z)-(amino(4-(((1-methyl-5-(pyridin-2-ylcarbamoyl)-1H-benzo
[d]imidazol-2-yl)methyl)amino)phenyl)methylene)carbamate
Desethyl Dabigatran Etexilate Carboxamide

DBG411 1580491-16-2
Desethyl Dabigatran Etexilate Carboxamide
Dabigatran Etexilate Isopropyl Ester Analog

DBG412 1610758-19-4
Dabigatran Etexilate Isopropyl Ester Analog
Dabigatran Etexilate Dimer

DBG413 2101852-25-7
Dabigatran Etexilate Dimer
Ethyl 3-(2-Pyridylamino)propionate
DBG414 103041-38-9
Ethyl 3-(2-Pyridylamino)propionate
4-(Methylamino)-3-nitrobenzoic acid
DBG415 41263-74-5
4-(Methylamino)-3-nitrobenzoic acid
Desiminomethyl Carbonyl Dabigatran Etexilate

DBG416 1408238-40-3 N-[[2-[[[4-[[[(Hexyloxy)carbonyl]amino]carbonyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-
yl]carbonyl]-N-2-pyridinyl-β-alanine Ethyl Ester
Page 22
Dabigatran Etexilate
DBG100 211915-06-9 N-[[2-[[[4-[[[(Hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-
yl]carbonyl]-N-2-pyridinyl-β-Alanine Ethyl Ester
Dabigatran Etexilate Mesylate Impurity A

DBG401 1408238-37-8 3-(2-(((4-(((Hexyloxy)carbonyl)carbamoyl)phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-
benzo[d]imidazole-5-carboxamido)propanoic Acid
DBG402 429658-95-7/ 211914-50-0 3-({2-[(4-Carbamimidoyl-phenylamino)-methyl]-1-methyl-1H-benzoimidazole-5-carbonyl}-pyridin-2-yl-
amino)-propionic acid ethyl ester
Dabigatran Methylamino Impurity

DBG404 212322-56-0
Dabigatran Methylamino Impurity
DBG405 212321-78-3
O-Desethyl Dabigatran Etexilate
DBG406 42288-26-6
N-(4-Cyanophenyl)glycine ; 2-(4-Cyanophenylamino)acetic acid
DBG407 1637238-96-0 Hexyl (imino(4-(((1-methyl-5-((3-oxo-3-(pyridin-2-ylamino)propyl)
(pyridin-2-yl)carbamoyl)-1H-benzo[d]imidazol-2-thyl)amino)phenyl)methyl)carbamate
DBG408 211915-00-3
Dabigatran Etexilate Methyl Ester Analog
Decitabine
DCT100 2353-33-5
4-amino-1-((2R,4S,5R)-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)-1,3,5-triazin-2(1H)-one
Decitabine Related Compound C

DCT303 1140891-02-6 (2R,3S,5S)-5-(4-amino-2-oxo-1,3,5-triazin-1(2H)-yl)-2-(((4-chlorobenzoyl)oxy)
methyl)tetrahydrofuran-3-yl 4-chlorobenzo
Desloratadine
Desloratadine
DSL100 100643-71-8
Loratadine USP RC A ; Loratadine EP Impurity D
298220-99-2 Desloratadine EP Impurity A

DSL201
Desloratadine EP Impurity A ; 11-Fluoro Dihydrodesloratadine
Desloratadine EP Impurity C
DSL203 79794-75-5 Loratadine ; Ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta
[1,2-b]pyridin-11-ylidene)-1-piperidinecarboxylate
Desloratadine N-Acetyl Impurity

DSL401 117796-52-8
Desloratadine N-Acetyl Impurity ; N-Acetyl Desloratadine
Desloratadine N-Formyl Impurity

DSL306 117810-61-4
Desloratadine USP RC F; Desloratadine N-Formyl Impurity
Page 23
Desloratadine N-Hydroxy Impurity
DSL402 1193725-73-3
Desloratadine N-Hydroxy Impurity ; N-Hydroxy Desloratadine ;
Desloratadine N-Methyl Impurity

DSL403 38092-89-6
Loratadine EP Impurity G ;Loratadine USP RC B
Desloratadine Pyridine N-Oxide

DSL404 169253-26-3 4-(8-Chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-
piperidine N-oxide
Desloratadine Nitroso Impurity

DSL405 1246819-22-6
8-Chloro-11-(1-nitrosopiperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine
Dextromethorphan
Dextromethorphan
DXT100 125-71-3 (9α,13α,14α)-3-Methoxy-17-methylmorphinan3-Methoxy-17
-methyl-9α,13α,14α-morphinan; (+)-3-Methoxy-17-methylmorphinan
Dextromethorphan Impurity A
DXT401 1531-25-5 (+)-3-Methoxy morphinan; (4bR,8aR,9R)-3-Methoxy-6,7,8,8a,9,10-hexahydro-5H-9,4b-
(epiminoethano)phenanthrene
Dextromethorphan Impurity B
DXT402 125-73-5
(+)-3-Hydroxy-N-methylmorphinan
Dextromethorphan N-Oxide Hydrochloride

DXT403 1177419-85-0
(9α,13α,14α)-3-Methoxy-17-methylmorphinan 17-oxide Hydrochloride
Diazepam
Diazepam
DZP100 439-14-5
7-Chloro-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one
Diazepam EP Impurity A/ Nordazepam

DZP201 1088-11-5
7-Chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one (nordazepam)
Diazepam EP Impurity B
DZP202 6021-21-2
2-Chloro-N-(4-chloro-2-benzoylphenyl)-N-methylacetamide
Diclazuril - Impurity A/Diclazuril 6-Carboxylic Acid

DCZ401 862243-46-7 2-[3,5-Dichloro-4-[(4-chlorophenyl)cyanomethyl]phenyl]-2,3,4,
5-tetrahydro-3,5-dioxo-1,2,4-triazine-6-carboxylic Acid
4-Dechloro-4-hydroxy Diclazuril (Impurity B)

DCZ402 112206-71-0
(+/-)-Benzeneacetonitrile, 4-Dechloro-4-hydroxy Diclazuril
Diclazuril 6-Carboxamide (Impurity C)

DCZ403 1797132-12-7
Diclazuril 6-Carboxamide
Descyano Diclazuril Ketone (Impurity D)

DCZ404 133648-81-4
2-[3,5-Dichloro-4-(4-chlorobenzoyl)phenyl]-1,2,4-triazine-3,5(2H,4H)-dione
Page 24
Descyano Diclazuril Ketone (Impurity F)
DCZ405 133648-80-3
2-[3,5-Dichloro-4-[(4-chlorophenyl)methyl]phenyl]-1,2,4-triazine-
Diclofenac Sodium
Diclofenac Sodium
DCL100 15307-79-6 Aceclofenac EP Impurity A ;
Sodium 2-[(2,6-dichlorophenyl)amino]phenyl]acetate
Diclofenac EP Impurity A
DCL201 15362-40-0 Diclofenac USP Related Compound A ;
Aceclofenac EP Impurity I ; Diclofenac Amide
Diclofenac EP Impurity B
DCL202 22121-58-0
2-[(2,6-Dichlorophenyl)amino]benzaldehyde
Diclofenac EP Impurity C
DCL203 27204-57-5
[2-[(2,6-Dichlorophenyl)amino]phenyl]methanol
Diclofenac EP Impurity D
DCL204 127792-45-4
2-[2-[(2-Bromo-6-chlorophenyl) amino]phenyl] acetic acid
Diclofenac EP Impurity E
DCL205 59-48-3
1,3-Dihydro-2H-indol-2-one
Diclofenac EP Impurity F
DCL206 560075-65-2
N-(4-chlorophenyl)-2-(2,6-dichlorophenyl)acetamide
Diltiazem
Diltiazem HCl
DLT100 42399-41-7 (2S,3S)-5-[2-(Dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,
4,5-tetrahydro-1,5-benzothiazepin-3-yl acetate hydrochloride
Diltiazem EP Impurity B
DLT202 87447-47-0 (2S,3S)-2-(4-Methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-
1,5-benzothiazepin-3-yl acetate
Diltiazem EP Impurity E
DLT205 42399-49-5 (2S,3S)-3-Hydroxy-2-(4-methoxyphenyl)-2,3-
dihydro-1,5-benzothiazepin-4(5H)-one
Diltiazem EP Impurity F
DLT206 42399-40-6/ 23515-45-9/75472-91-2
Desacetyl Diltiazem,
Dobesilate Monohydrate
DBS100 117552-78-0 Dobesilate Monohydrate
DBS401 123-31-9 Dobesilate Impurity A
Donepezil Hydrochloride
Page 25
Donepezil Hydrochloride
DNP100 120011-70-3
(±)-2-[(1-Benzyl-4-piperidyl)methyl]-5,6-dimethoxy-1-indanone hydrochloride
Donepezil EP Impurity A
DNP201 120014-30-4
Donepezil Desbenzyl Impurity ; 5,6-Dimethoxy-2-(piperidin-4-ylmethyl) indan-1-one
Donepezil EP Impurity B
DNP202 2107-69-9
5,6-dimethoxy-2,3-dihydro-1H-inden-1-one
Donepezil EP Impurity D
DNP204 4803-57-0
Donepezil Pyridine Impurity; 5,6-Dimethoxy-2-(pyridin-4-ylmethyl)indan-1-one
Donepezil EP Impurity F
DNP206 145546-80-1 Donepezil Related Compound A, Donepezil Dehydro Impurity ; (E)-Dehydro Donepezil ;
(E)-2-[(1-Benzylpiperidin-4-yl)methylene]-5,6-dimethoxyindan-1-one
Donepezil Benzyl Bromide

DNP401 844694-85-5
Donepezil Benzyl Bromide ; 1,1-Dibenzyl-4-[(5,6-dimethoxy-1-oxoindan-2-yl) methyl]piperidinium bromide
Donepezil N-Oxide
DNP402 120013-84-5
(RS)-2-[(1-Benzyl-4-piperidyl)methyl]-5,6-dimethoxy-1-indanone N-Oxide
Donepezil hydroxy impurity

DNP403 197010-20-1
2,3-Dihydro-2-[hydroxy[1-(phenylmethyl)-4-piperidinyl]methyl]-5,6-dimethoxy-1H-inden-1-one
Dorzolamide
Dorzolamide
DRZ100 130693-82-2 (4S,6S)-4-(Ethylamino)-6-methyl-5,6-dihydro-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide
hydrochloride
DORZOLAMIDE IMPURITY B
DRZ202 120279-37-0 Dorzolamide Related Compound B, (4RS,6SR)-4-(Ethylamino)-6-methyl-5,6-dihydro-4H
-thieno[2, 3-b]thiopyran-2-sulfonamide 7,7-dioxide Hcl
Doxazosin Mesylate
Doxazosin Mesylate
DXZ100 77883-43-3/74191-85-8 1-(4-Amino-6,7-dimethoxyquinazolin-2-yl)-4-[(2RS)-2,3-dihydro
-1,4-benzodioxin-2-ylcarbonyl]piperazine methanesulphonate
Duloxetine Hydrochloride
Duloxetine Hydrochloride
DLX100 136434-34-9
(S)-N-Methyl-γ-(1-naphthalenyloxy)-2-thiophenepropanamine Hydrochloride
Duloxetine EP Impurity B
DLX202 116539-55-0
Duloxetine alcohol (USP) ; (1S)-3-(Methylamino)-1-(thiophen-2-yl)propan-1-ol
Duloxetine EP Impurity D
DLX204 90-15-3
α-Napthol (USP) ; Naphthalen-1-ol
Page 26
Elagolix sodium
Elagolix sodium
ELG100 834153-87-6 4-[[(1R)-2-[5-(2-Fluoro-3-methoxyphenyl)-3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-3,6-dihydro-4-
methyl-2,6-dioxo-1(2H)-pyrimidinyl]-1-phenylethyl]amino]butanoic acid
Elagolix Impurity 1
ELG501 133116-83-3
2-Fluoro-6-(trifluoromethyl)benzonitrile
Elagolix Impurity 2
ELG502 239087-06-0
2-Fluoro-6-(trifluoromethyl)benzylamine
Emtricitabine
Emtricitabine
EMT100 143491-57-0
4-Amino-5-fluoro-1-[(2R,5S)-2-hydroxymethyl)-1,3-oxathiolan-5-yl]-2-(1H-pyrimidinone
Emtricitabine impuirty 1
EMT501 147126-75-8 5-(4-Amino-5-fluoro-2-oxo-1(2H)-pyrimidinyl)-1,3-oxathiolane-2-carboxylic acid
5-methyl-2-(1-methylethyl)cyclohexyl ester
Enalapril
Enalaprili Maleate
ENL100 76095-16-4
((S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl)-L-alanyl-L-proline
Enalapril Alanyl Proline

ENL501 13485-59-1
Enalapril Dipeptide Impurity ;L-Alanyl-L-proline
Enalapril Impurity 1
ENL502 501-52-0
Phenylpropanoic acid, Benzenepropionic acid, 3-Phenyl-n-propionic acid
Eprosartan
Eprosartan
EPR100 133040-01-4
(E)-3-[2-Butyl-1-[(4-carboxyphenyl)methyl]-imidazol-5-yl]-2-(2-thienyl methyl)-2-propenoic acid
EPR501 Eprosartan impurity 1
Erythromycin
ERY100 114-07-8 Erythromycin
Esketamine Hydrochloride
ESK100 33643-47-9
(2S)-2-(2-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride
Page 27
Esketamine EP Impurity A
ESK201 6740-87-0
1-[(2-chlorophenyl)(methylimino)methyl]cyclopentanol
Esketamine EP Impurity B
ESK202 1823362-29-3
(2RS)-2-(2-chlorophenyl)-2-hydroxycyclohexanone
Esketamine EP Impurity C
ESK203 90717-17-2
(2-chlorophenyl)(1-hydroxycyclopentyl)methanone
ESKETAMINE IMPURITY A HCL SALT

ESK401 90717-16-1
ESKETAMINE IMPURITY A HCL SALT
Esomeprazole
Esomeprazole
ESM100 119141-88-7
5-Methoxy-2-((S)-((4-methoxy-3,5-dimethyl-2- pyridinyl)methyl)sulfinyl)-1H-benzimidazole
Esomeprazole EP Impurity A
ESM201 37052-78-1
Omeprazole EP Impurity A ; 5-Methoxy-1H-benzimidazole-2-thiol
Esomeprazole EP Impurity C
ESM203 73590-85-9 Omeprazole EP Impurity C ; 5-methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfanyl]-1H-
benzimidazole (ufiprazole)
Esomeprazole EP Impurity D
ESM204 88546-55-8
Esomeprazole USP Related Compound A ; Esomeprazole USP RC A ; Omeprazole Sulfone
Esomeprazole EP Impurity E
ESM205 176219-04-8
Omeprazole EP Impurity E ; Omeprazole N-Oxide ; Omeprazole USP Related Compound E
Estradiol
Estradiol
EST100 50-28-2 (8R,9S,13S,14S,17S)-13-methyl-7,8,9,11,12,13,14,15,16,17
-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol
Estradiol Related Compound B
EST302 7291-41-0
6,7-Dehydro Estradiol
Ethacrynic Acid
Ethacrynic Acid
ETH100 58-54-8
2-[2,3-Dichloro-4-(2-methylene-1-oxobutyl)phenoxy]acetic Acid
Ethacrynic Acid impurity A

ETH201 1217-67-0
4-Butanoyl-2, 3-dichlorophenoxy acetic acid
Ethacrynic Acid Impurity 4, Ethacrynic Acid Impurity E

ETH401 55507-91-0
[2,3-dichloro-4-(2-methylacryloyl)phenoxy]acetic acid
Ethacrynic Acid Epoxide

ETH402 27223-10-5
2-(2,3-Dichloro-4-(2-ethyloxirane-2-carbonyl)phenoxy)acetic acid
Page 28
Etoricoxib
Etoricoxib
ETR100 202409-33-4
5-chloro-6'-methyl-3-(4-(methylsulfonyl)phenyl)-2,3'-bipyridine
Etoricoxib USP Related Compound A

ETR301 10297-73-1
4-(Methylsulfonyl)acetophenone ; 1-[4-(Methylsulfonyl)phenyl]ethanone;
Etoricoxib USP Related Compound B

ETR302 90536-66-6
2-(4-(methylsulfonyl)phenyl)acetic acid
Etoricoxib Impurity C
ETR401 249561-98-6
N-(2-Chloro-3-(dimethylamino)allylidene)-N-methylmethanaminium hexafluorophosphate(V)
Etoricoxib Impurity D
ETR402 221615-75-4
1-(6-methylpyridin-3-yl)-2-(4-(methylsulfonyl)phenyl)ethan-1-one
Etoricoxib Impurity-F
ETR403 325855-74-1 Etoricoxib N1’-Oxide
5-Chloro-6'-methyl-3-[4-(methylsulfonyl)phenyl]-2,3'-bipyridine 1'-Oxide
Etoricoxib CDPTH salt

ETR404 NA
2-chloro-1, 3-bis (piperidyl) trimethinium hexafluoro phosphate
Febuxostat
Febuxostat
FBX100 144060-53-7
2-[3-Cyano-4-(2-methylpropoxy)phenyl]-4-methylthiazole-5-carboxylic acid
Febuxostat Amide Impurity

FBX401 1239233-86-3
2-(3-Carbamoyl-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylic acid
Febuxostat Dicarboxylic Acid Impurity

FBX402 1239233-87-4
2-[3-Carboxy-4-(2-methylpropoxy)phenyl]-4-methyl-5-thiazolecarboxylic acid
Febuxostat Ethyl Ester

FBX403 160844-75-7
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate
Febuxostat Isopropyl Ester

FBX404 1346238-10-5
Isopropyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate
Febuxostat Methyl Ester

FBX405 923942-34-1
Methyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate
Febuxostat Impurity 2
FBX406 161798-03-4
ethyl 2-(3-formyl-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate
Febuxostat Impurity 8
FBX407 144060-62-8
2-(3-formyl-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylic acid
Febuxostat Butyl Ester Impurity

FBX408 1619982-02-3
butyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate
Page 29
FBX409 2476465-11-7 3-Descyano-3-ethoxycarbonyl Febuxostat
Felbamate
FLB100 Felbamate
25451-15-4
Felbamate Related Compound A

FLB301 25451-53-0
3-hydroxy-2-phenylpropyl carbamate
Felbamate Related Compound B

FLB302 6326-19-8
phenethyl carbamate
Felbamate Dimer
FLB401 1796927-91-7
(carbonylbis(oxy))bis(2-phenylpropane-3,1-diyl) dicarbamate
FLB402 1570-95-2 2-Phenyl-1,3-propanediol
4-Hyrdroxy Felbamate
FLB403 109482-28-2
2-(4-Hydroxyphenyl)-1,3-propanediyl Dicarbamate
Fenbendazole impurity A
FND201 10605-21-7
Methyl 1H-benzimidazol-2-ylcarbamate, Fenbendazole Related Compound A
Fenbendazole
FND100 Fenbendazole
Fenofibrate
Fenofibrate
FNB100 49562-28-9
Isopropyl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate
Fenofibrate EP Impurity A
FNB201 42019-78-3
Fenofibrate USP Related Compound A ; (4-Chlorophenyl)(4-hydroxyphenyl)methanone
Fenofibrate EP Impurity B
FNB202 42017-89-0 Fenofibrate USP Related Compound B ; Fenofibric Acid ;
2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropanoic acid
Fenofibrate EP Impurity F
FNB206 154356-96-4
(4-Chlorophenyl)[4-(1-methylethoxy)phenyl]methanone
Page 30
Fenofibrate EP Impurity G
FNB207 217636-48-1 Fenofibrate USP Related Compound C ;
1-Methylethyl 2-[[2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoyl]oxy]-2-methylpropanoate
Fenticonazole
Fenticonazole Nitrate
FNT100 73151-29-8
1-(2-(2,4-dichlorophenyl)-2-((4-(phenylthio)benzyl)oxy)ethyl)-1H-imidazole nitrate
Fenticonazole Nitrate EP Impurity A

FNT201 24155-42-8
1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl)ethan-1-ol
Fenticonazole Nitrate EP Impurity B

FNT202 80639-95-8 1-(2-(2,4-dichlorophenyl)-2-((4-(phenylsulfinyl)benzyl)oxy)ethyl)
-1H-imidazole nitrate
Fenticonazole Nitrate EP Impurity C

FNT203 80676-29-5
1-(2-(2,4-dichlorophenyl)-2-((4-(phenylsulfonyl)benzyl)oxy)ethyl)-1H-imidazole
Fenticonazole Nitrate EP Impurity D

FNT204 1313397-05-5
3-(2-(2,4-dichlorophenyl)-2-hydroxyethyl)-1-(4-(phenylthio)benzyl)-1H-imidazol-3-ium nitrate
Fenticonazole Nitrate EP Impurity E

FNT205 756429-44-4 3-(2-(2,4-dichlorophenyl)-2-((4-(phenylthio)benzyl)oxy)ethyl)-1-(4-(phenylthio)
benzyl)-1H-imidazol-3-ium Hydrochloride
4-phenyl thio benzyl chloride

FNT501 1208-87-3
(4-(chloromethyl)phenyl)(phenyl)sulfane
Fexofenadine
Fexofenadine
FXN100 83799-24-0
(R)-2-(4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)piperidin-1-yl)butyl)phenyl)-2-methylpropanoic acid
Fexofenadine EP Impurity A
FXN201 76811-98-8
Fexofenadine USP related compound A
Fexofenadine EP Impurity C
FXN203 185066-37-9
Decarboxylated degradant
Fexofenadine EP Impurity E
FXN205 115-46-8
diphenyl(piperidin-4-yl)methanol
Fexofenadine Impurity 1
FXN401 154477-54-0
methyl 2-(4-(4-chlorobutanoyl)phenyl)-2-methylpropanoate
Flecainide
Flecainide acetate
FLC100 54143-56-5
N-(piperidin-2-ylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide acetate
Flecainide EP Impurity B
FLC202 22990-77-8
(RS)-(piperidin-2-yl)methanamine
Page 31
Fluoxetine
Fluoxetine HCl
FLX100 56296-78-7
N-Methyl-γ-[4-(trifluoromethyl)phenoxy]benzenepropanamine Hydrochloride
Fluoxetine EP Impurity A
FLX201 42142-52-9
α-[2-(Methylamino)ethyl]benzyl Alcohol, 3-(methylamino)-1-phenylpropan-1-ol
Fluoxetine EP Impurity B
FLX202 23580-89-4/ 30684-07-2
Fluoxetine USP Related Compound B
Fluoxetine EP Impurity C
FLX203 56161-72-9
N-Methyl-3-phenyl-3-(3-(trifluoromethyl)phenoxy)propan-1-amine
Fluoxetine Related Compound A

FLX301 79088-29-2 N-Methyl-γ-[3-(trifluoromethyl)phenoxy]benzenepropanamine Hydrochloride; N-Methyl-3-phenyl-3-[(α,α,α-
trifluoro-m-tolyl)oxy]propylamine Hydrochloride
Fosfomycin
Fosfomycin Tromethamine
FSM100 78964-85-9 2-amino-2-(hydroxymethyl)propane-1,3-diol ((2R,3S)-3-methyloxiran-2-yl)
phosphonate
Fosfomycin Trometamol EP Impurity A

FSM201 84954-80-3
1,2-dihydroxypropyl)phosphonic acid
Fosfomycin Trometamol EP Impurity C

FSM203 23001-39-0
2-amino-3-hydroxy-2-(hydroxymethyl)propyl dihydrogen phosphate
Gabapentin
Gabapentin
GBP100 60142-96-3
1-(Aminomethyl)cyclohexaneacetic acid
Gabapentin EP Impurity A
GBP201 64744-50-9 Gabapentin USP Related Compound A ;
Gabapentin Lactam ; 3-Azaspiro-[4,5]decan-3-one
Gabapentin EP Impurity B
GBP202 133481-09-1
Gabapentin USP Related Compound B ; (1-Cyanocyclohexyl)acetic acid
Gabapentin EP Impurity E
GBP205 67950-95-2 Gabapentin USP Related Compound E ;
Gabapentin Diacid ; 1-(carboxymethyl)cyclohexanecarboxylic acid
Gliclazide
Gliclazide
GLC100 21187-98-4
1-(Hexahydrocyclopenta[c]pyrrol-2(1H)-yl)-3-[(4-methylphenyl)sulfonyl]urea
Gliclazide EP Impurity A
GLC201 70-55-3
Gliclazide BP Impurity A ; 4-Methylbenzenesulfonamide
Page 32
Gliclazide EP Impurity B
GLC202 54786-86-6
Gliclazide BP Impurity B ; 2-Nitroso-octahydrocyclopenta[c]pyrrole
Gliclazide EP Impurity C
GLC203 5577-13-9
Gliclazide BP Impurity C ; Ethyl [(4-methylphenyl)sulfonyl]-carbamate
Gliclazide EP Impurity D
GLC204 1136426-19-1 Gliclazide BP Impurity D ; N-[(4-Methylphenyl)sulfonyl]hexahydrocyclopenta[c]
pyrrol-2(1H)-carboxamide
Gliclazide Impurity 1
GLC401 58108-05-7
hexahydrocyclopenta[c]pyrrol-2(1H)-amine hydrochloride
Glimepiride
Glimepiride
GLM100 93479-97-1 1-[[p-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)
ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea
Glimepiride EP Impurity B
GLM202 119018-29-0
USP Glimepiride Related Compound B ; Glimepiride Sulfonamide
Glimepiride EP Impurity C
GLM203 119018-30-3
Glimepiride Ester, GLIMEPIRIDE RELATED COMPOUND C
Sulfonyl-N-ethylcarbamic ethyl ester
GLM401 NA Ethyl ethyl((4-(2-(3-ethyl-4-methyl-2-oxo-2,5-dihydro-1H-pyrrole-1-carboxamido) ethyl)
phenyl)sulfonyl)carbamate
Phenylethyl Impurity
GLM401-AI 247098-18-6
3-Ethyl-4-methyl-2-oxo-N-phenethyl-2,5-dihydro-1H-pyrrole-1-carboxamide
Phenylethyl Impuriy sulphonyl chloride

GLM401-AII 119043-16-2
4-[2-(3-Ethyl-4-methyl-2-carbonyl pyrrolidine amido)ethyl] benzene sulfonyl chloride
Sulfonyl-N-ethyl glimepiride
GLM402 NA
3-ethyl-N-[2-[4-[[ethyl[(trans-4-methylcyclohexyl)amino]carbonyl]amino]sulfonylphenyl]ethyl]
Glipizide
Glipizide
GLP100 9094-61-9 N-[2-[4[[[(Cyclohexylamino)carbonyl]amino]sulfonyl]phenyl]ethyl]-
5-methylpyrazinecarboxamide
Glipizide EP Impurity A
GLP201 33288-71-0 Glipizide Related Compound A ;
[2-(4-Sulphamoylphenyl) ethyl] 5-methyl-pyrazine-2-carboxamide ;
Glipizide EP Impurity B
GLP202 108-91-8
cyclohexanamine
Page 33
Glipizide EP Impurity G
GLP207 33288-74-3 methyl ((4-(2-(5-methylpyrazine-2-carboxamido)ethyl)phenyl)sulfonyl)
carbamate
Guaifenesin
Guaifenesin
GFN100 93-14-1
Ranolazine Related Compound 2 ; 3-(2-methoxyphenoxy)propane-1,2-diol
Guaifenesin EP Impurity A
GFN201 90-05-1
2-methoxyphenol
Guaifenesin EP impurity C
GFN203 1797132-23-0
1,7-Di(2-methoxyphenoxy)-2,6-dihydroxy-4-oxaheptane;3,3'-Oxybis(1-(2-methoxyphenoxy)propan-2-ol)
Guaifenesin EP Impurity D
GFN204 16929-60-5
Dianisylglycerol ; 1,3-bis(2-methoxyphenoxy)propan-2-ol
Guaifenesin Impurity 1
GFN401 2210-74-4
2-((2-methoxyphenoxy)methyl)oxirane
Guanine
Guanine
GNN100 73-40-5
2-amino-9H-purin-6(1H)-one
Haloperidol
Haloperidol
HLP100 52-86-8
4-(4-(4-Chlorophenyl)-4-hydroxy-1-piperidinyl)-1-(4-fluorophenyl)-1-butanone
Haloperidol EP Impurity A
HLP201 3109-12-4
1-(4-fluorophenyl)-4-(4-hydroxy-4-phenylpiperidin-1-yl)butan-1-one ; Dechlorohaloperidol
Haloperidol EP Impurity B
HLP202 1391052-53-1
Haloperidol Related Compound B
Haloperidol EP Impurity D
HLP204 67987-08-0
Haloperidol USP Related Compound A
Haloperidol EP Impurity H
HLP208 148406-51-3
Haloperidol N-Oxide
Haloperidol Impurity 8
HLP401 3874-54-2 Chloro-fluoro-butyrophenone ; 4-chloro-1-(4-fluorophenyl)butan-1-one; 3-(4-Fluorophenylcarbonyl)-1-
chloropropane
Haloperidol Impurity 9
HLP402 39512-49-7
4-(4-chlorophenyl)-4-hydroxypiperidine ; Chlorophenyl hydroxypiperidine
trans-Haloperidol N-Oxide
HLP403 150214-93-0
4-[trans-4-(4-Chlorophenyl)-4-hydroxy-1-oxido-1-piperidinyl]-1-(4-fluorophenyl)-1-butanone
cis-Haloperidol N-Oxide
HLP404 150214-94-1
4-[cis-4-(4-Chlorophenyl)-4-hydroxy-1-oxido-1-piperidinyl]-1-(4-fluorophenyl)-1-butanone
Page 34
Hydralazine
Hydralazine Impurity-A
HYR401 253-52-1
Phthalazine
Hydrochlorothiazide
Hydrochlorothiazide
HYD100 58-93-5
6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide
Hydrochlorothiazide EP Impurity A
HYD201 DATE
3,4-Dehydro Hydrochlorothiazide ; Chlorothiazide
Hydrochlorothiazide EP Impurity B
HYD202 121-30-2
Hydrochlorothiazide USP Related Compound A
Hydroxychloroquine Sulfate
HYX100 747-36-4
2-[[4-[(7-Chloro-4-quinolinyl)amino]pentyl]ethylamino]ethanol Sulfate
Hydroxychloroquine EP Impurity G
HYX207 86-98-6 4,7-Dichlrorquinoline
Ibuprofen
Ibuprofen
IBP100 15687-27-1
(2RS)-2-(4-isobutylphenyl)propanoic acid
Ibuprofen EP Impurity B
IBP202 3585-49-7
(2RS)-2-(4-butylphenyl)propanoic acid
Ibuprofen EP Impurity E
IBP205 38861-78-8 Ibuprofen USP Related Compound C ;
1-(4-isobutylphenyl)ethan-1-one ; 1-[4-(2-methylpropyl)phenyl]ethanone
Ibuprofen Ethyl Ester

IBP401 41283-72-1
2-(4-Isobutylphenyl)propionic acid ethyl ester
Ibuprofen EP Impurity J
IBP210 65813-55-0
Ibuprofen EP Impurity J; (2RS)-2-(4-Isobutyrylphenyl)propanoic acid
Iguratimod
Iguratimod
IGR100
123663-49-0 N-(7-(Methylsulfonamido)-4-oxo-6-phenoxy-4H-chromen-3-yl)formamide
Iopamidol
Iopamidol impuirty A
IPM201 60166-98-5
5-amino-N,N'-bis[2-hydroxy-1-(hydroxymethyl)ethyl]-2,4,6-triiodobenzene-1,3-dicarboxamide,
Iopamidol impuirty B
IPM202 77868-41-8 5-[(hydroxyacetyl)amino]-N,N'-bis[2-hydroxy-1-(hydroxymethyl)ethyl]-2,4,6-triiodobenzene-1,3-
dicarboxamide,
Iopamidol impuirty C
IPM203
5-(acetylamino)-N,N'-bis[2-hydroxy-1-(hydroxymethyl)ethyl]-2,4,6-triiodobenzene-1,3-dicarboxamide
Page 35
IOPAMIDOL RELATED COMPOUND C
IPM303 NA
4-Chloro-N1, N3 -bis(1,3-dihydroxypropan-2-yl)-5-(S)-lactamido-2,6-diiodoisophthalamide.
Irbesartan
Irbesartan
IRB100 138402-11-6
2-Butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one
Irbesartan EP Impurity A
IRB201 748812-53-5
Irbesartan USP Related Compound A
Irbesartan Lactam Impurity

IRB401 151257-01-1
2-Butyl-1,3-diazaspiro[4.4]non-1-en-4-one Hydrochloride
Irbesartan Bromo Nitrile Impurity

IRB402 114772-54-2
4'-(Bromomethyl)biphenyl-2-carbonitrile
Irbesartan Dibromomethyl Impurity

IRB403 209911-63-7
4'-(Dibromomethyl)biphenyl-2-carbonitrile
Irbesartan Hydroxy Impurity

IRB404 160514-13-6
Candesartan Hydroxy Impurity ; p-(o-1H-Tetrazol-5-ylphenyl)benzyl alcohol
Irbesartan Impurity 1
IRB405 154709-19-0
2-[4-(Hydroxymethyl)phenyl]benzonitrile; 4-(Hydroxymethyl)-2'-cyanobiphenyl
Isosorbide
isosorbide
ISR100 652-67-5
1,4:3,6-Dianhydro-D-glucitol
Isosorbide Mononitrate EP Impurity A

ISR201 87-33-2
Isosorbide Dinitrate
Isosorbide Mononitrate EP Impurity B

ISR202 16051-77-7
1,4:3,6-Dianhydro-D-glucitol 5-Nitrate,Isosorbide 5-Mononitrate
Itraconazole
Itraconazole
ITR100 84625-61-6 (±)-1-[(RS)-sec-butyl]-4-[p-[4-[p-[[(2R,4S)-rel-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-
dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4-triazolin-5-one
Ivabradine
Ivabradine Hydrochloride
IVB100 148849-67-6 (S)-3-(3-(((4,5-dimethoxy-1,2 dihydrocyclobutabenzen1yl)methyl)(methyl)amino)propyl)-7,8-dimethoxy-4,5-
dihydro-1Hbenzo[d]azepin-2(3H)-one hydrochloride
Ivabradine Impurity 2
IVB401 73942-87-7
7,8-dimethoxy-1,3-dihydro-2H-benzo[d]azepin-2-one
Page 36
Ivabradine chloro Impurity
IVB402 85175-59-3
3-(3-chloropropy)-7,8-dimethoxy-1,3-dihydro-2H-benzo[d]azepin-2-one
Ivabradine Iodo Impurity

IVB403 148870-57-9
3-(3-iodopropyl)-7,8-dimethoxy-1,3-dihydro-2H-benzo[d]azepin-2-one
IVB404 85175-65-1
3-(3-chloropropyl)-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-benzo[d]azepin-2-one
IVB405 109-70-6
1-bromo-3-chloropropane
IVB406 NA
3,3'-(propane-1,3-diyl)bis(7,8-dimethoxy-1,3,4,5-tetrahydro-2H-benzo[d]azepin-2-one)
rac-Ivabradine
IVB407 1796933-38-4 3-(3-(((3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl)(methyl)amino)propyl)-7,8-dimethoxy-1,3,4,5-
tetrahydro-2H-benzo[d]azepin-2-one hydrochloride
IVB408 866783-13-3
(S)-1-(3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)-N-methylmethanamine hydrochloride
2-Oxo-Ivabradine
IVB409 1616710-50-9 (S)-3-(3-(((3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl)(methyl)amino)propyl)-7,8-dimethoxy-4,5-
dihydro-1H-benzo[d]azepine-1,2(3H)-dion
Ketamine
Ketamine Hydrochloride
KTM100 1867-66-9
(2RS)-2-(2-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride.
Ketamine impurity A
KTM201 6740-87-0
1-[(2-Chlorophenyl)-(methylimino)methyl]cyclopentanol
ketamine EP Impurity B
KTM202 1823362-29-3
(2RS)-2-(2-chlorophenyl)-2-hydroxycyclohexanone
ketamine EP Impurity C
KTM203 90717-17-2
(2-chlorophenyl)(1-hydroxycyclopentyl)methanone
Ketamine impurity 1
KTM401 6740-86-9
(1-Bromocyclopentyl)(2-chlorophenyl)methanone
Ketoprofen
Ketoprofen
KTP100 22071-15-4
2-(3-benzoylphenyl)propanoic acid
ketoprofen EP impurity A
KTP201 66067-44-5 Ketoprofen Related Compound D;
1-(3-benzoylphenyl)ethan-1-one
Page 37
ketoprofen EP impurity C
KTP203 68432-95-1
3-(1-carboxyethyl)benzoic acid, Ketoprofen Related Compound C
ketoprofen EP impurity D
KTP204 107257-20-5
2-(3-(4-methylbenzoyl)phenyl)propanoic acid, Ketoprofen Related Compound A
ketoprofen EP impurity E
KTP205 59512-16-2
2-(3-benzoylphenyl)propanamide
ketoprofen EP impurity F
KTP206 42872-30-0
2-(3-benzoylphenyl)propanenitrile
ketoprofen EP impurity G
KTP207 5537-71-3
3-(1-cyanoethyl)benzoic acid
KTP208 5689-33-8 Ketoprofen EP Impurity H
Labetalol
Labetalol
LBT100 32780-64-6 2-hydroxy-5-((S)-1-hydroxy-2-(((S)-4-phenylbutan-2-yl)amino)ethyl)
benzamide hydrochloride
Labetalol EP Impurity A
LBT201 1391051-99-2
2-Hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzoic Acid
Labetalol EP Impurity B
LBT202 802620-01-5/33778-93-7
methyl 2-hydroxy-5-((S)-1-hydroxy-2-(((S)-4-phenylbutan-2-yl)amino)ethyl)benzoate
Labetalol EP Impurity C
LBT203 NA
5-(2-(benzylamino)-1-hydroxyethyl)-2-hydroxybenzamide
Labetalol EP Impurity D
LBT204 NA
5-[(1RS)-2-amino-1-hydroxyethyl]-2-hydroxybenzamide
Labetalol EP Impurity G
LBT207 NA
3-bromo-2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide.
Lacidipine
Lacidipine
LCD100 3890-78-4
Diethyl 4-{o-[(E)-2-tert-butoxycarbonylethenyl]phenyl}-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
cis Lacidipine
LCD401 103890-79-5 (Z)-4-[2-[3-(1,1-Dimethylethoxy)-3-oxo-1-propenyl]phenyl]-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic
Acid Diethyl Ester
Lacosamide
Page 38
Lacosamide
LCS100 175481-36-4
(2R)-2-(Acetylamino)-3-methoxy-N-(phenylmethyl)propanamide
Lacosamide EP Impurity A
LCS201 175481-37-5
(S)-2-(Acetylamino)-3-methoxy-N-(phenylmethyl)propanamide
Lacosamide EP Impurity B
LCS202 1318777-54-6
Lacosamide O-Acetyl Impurity , Lacosamide BP Impurity B
Lacosamide EP Impurity C
LCS203 2742962-60-1
(R)-N-Benzyl-3-methoxy-2-(N-methylacetamido)propanamide
Lacosamide EP Impurity D
LCS204 196601-69-1
(2R)-2-Amino-3-methoxy-N-(phenylmethyl)-propanamide. BP Impurity D
Lacosamide EP Impurity E
LCS205 175481-39-7
Lacosamide BP Impurity E, Desacetyl desmethyl Lacosamide
Lacosamide EP Impurity F
LCS206 175481-38-6
Desmethyl Lacosamide(Hydroxy Imp)
Lacosamide EP Impurity G
LCS207 588-46-5
N-benzyl acetamideLacosamide, N-(Phenylmethyl)-acetamide
Lacosamide EP Impurity H
LCS208 NA
USP Dimer (R, R isomer)
Lacosamide EP Impurity I
LCS209 2295925-90-3
(R)-N-benzyl-2-(3-benzylureido)-3-methoxypropanamide
Lacosamide EP Impurity J
LCS210 100-46-9
phenylmethanamine
Lacosamide EP Impurity K
LCS211 86921-49-5
2-acetamido-N-benzylacrylamide
Lacosamide EP Impurity L
LCS212 388619-64-5
(R)-2-(Acetylamino)-3-methoxy-N-methyl-N-(phenylmethyl)-propanamide
N-Acetyl-O-methyl-D-serine
LCS401 196601-67-9
N-Acetyl-O-methyl-D-serine; (R)-2-(Acetylamino)-3-methoxypropionic Acid
Lacosamide Impurity 1
LCS402 NA
2-acetamido-3-methoxypropanamide
Lacosamide Impurity C
LCS403 1466-67-7
1,3-Dibenzyl-urea; N,N'-Bis(phenylmethyl)urea
2-Acetamido-N-benzyl-3-hydroxypropanamide
LCS404 171623-02-2
2-Acetamido-N-benzyl-3-hydroxypropanamide
2-Amino-3-hydroxy-N-(phenylmethyl)-propanamide
LCS405 NA
2-Amino-3-hydroxy-N-(phenylmethyl)-propanamide
Lacosamide Related Compound A

LCS301 NA
(R)-tert-Butyl 1-(Benzylamino)-3-methoxy-1-oxopropan-2-ylcarbamate.
Page 39
Lamotrigine
LMT100 Lamotrigine
Lamotrigine EP Impurity A
LMT201 252186-78-0
Lamotrigine USP RC C ; 3-Amino-6-(2,3-dichlorophenyl)-1,2,4-triazin-5(4H)-one
Lamotrigine EP Impurity E
LMT205 50-45-3
Lamotrigine Related Compound B, 2,3-Dichlorobenzoic acid
LMT206 252186-79-1 Lamotrigine EP Impurity F
Lamotrigine Diamide Impurity

LMT401 1373393-59-9
Lamotrigine Related Compound D
Lansoprazole
Lansoprazole Sodium
LNS100 NA
2-[[3-Methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl]-1H-benzoimidazole
Lansoprazole EP Impurity A
LNS201 213476-12-1
Lansoprazole N-Oxide
Lansoprazole EP Impurity B
LNS202 131926-99-3
Lansoprazole USP Related Compound A ; Lansoprazole Sulfone, Dexlansoprazole Sulfone
Lansoprazole EP Impurity C
LNS203 103577-40-8/1288338-69-1
Lansoprazole USP Related Compound B ; Lansoprazole Sulfide
Lansoprazole EP Impurity D
LNS204 615-16-7
1H-Benzimidazol-2-ol ; 2-Hydroxybenzimidazole
Lansoprazole EP Impurity E
LNS205 583-39-1
2-Mercaptobenzimidazole
Lansoprazole Sulfide N-Oxide

LNS401 163119-30-0
2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]thio]-1H-benzimidazole N-Oxide
Lansoprazole Sulfone N-Oxide

LNS402 953787-54-7
2-[[[3-Methyl-1-oxido-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfonyl]-1H-benzimidazole
Leflunomide
Leflunomide
LFN100 75706-12-6
5-methyl-N-(4-(trifluoromethyl)phenyl)isoxazole-4-carboxamide
Leflunomide EP Impurity A
LFN201 455-14-1
Leflunomide USP RC A ; 4-(trifluoromethyl)aniline
Page 40
Leflunomide EP Impurity B
LFN202 163451-81-8
Leflunomide USP RC B ; (Z)-2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)but-2-enamide, Teriflunomide
Leflunomide EP Impurity C
LFN203 61643-23-0
Leflunomide USP RC C ; 5-methyl-N-(3-(trifluoromethyl)phenyl)isoxazole-4-carboxamide
Leflunomide EP Impurity D
LFN204 42831-50-5
5-methylisoxazole-4-carboxylic acid
Leflunomide EP Impurity E
LFN205 208401-20-1
Leflunomide EP Impurity F
LFN206 1403564-06-6
Leflunomide EP Impurity G
LFN207 724429-16-7
5-methyl-N-(p-tolyl)isoxazole-4-carboxamide
Leflunomide EP Impurity H
LFN208 24522-30-3
2-cyano-N-(4-(trifluoromethyl)phenyl)acetamide
Leflunomide Impurity 1
LFN401 20328-15-8
ethyl 3-methylisoxazole-4-carboxylate
LFN402 17153-20-7
3-Methylisoxazole-4-carboxylic Acid
LFN403 1011244-72-6
4-Amino-N-[4-(trifluoromethyl)phenyl]benzamide/ Teriflunomide Impurity 3
Lenalidomide
Lenalidomide
LND100 191732-72-6
3-(4-Amino-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-2,6-piperidinedione
Levocetirizine
Levocetirizine
LVC100 130018-77-8
(R)-2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic acid
Levocetirizine EP Impurity G
LVC207 109806-71-5
(RS)-2-[4-[(4-chlorophenyl)phenylmethyl]piperazin-1-yl]ethan-1-ol
Levocetirizine Impurity 2
LVC401 300543-56-0
(R)-1-((4-chlorophenyl)(phenyl)methyl)piperazine, Chlorobenzhydryl Piperazine
Levocetirizine Impurity 1
LVC402 1150310-68-1
Levocetirizine N-Benzylamide
Levodopa
Levodopa
LVD100 59-92-7
(S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
Page 41
Levodopa EP Impurity A
LVD201 27244-64-0
Levodopa USP Related Compound A ; (2S)-2-Amino-3-(2,4,5-trihydroxyphenyl)propanoic acid
Levodopa EP Impurity B
LVD202 60-18-4
L-tyrosine ; (2S)-2-Amino-3-(4-hydroxyphenyl)propanoic acid
Levodopa EP Impurity C
LVD203 7636-26-2
Levodopa USP Related Compound B ; 3-Methyl-DL-Dopa ; 3-Methoxy-DL-tyrosine
Levodopa EP Impurity D
LVD204 5796-17-8
(R)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid ; D-Dopa
Levodopa Impurity 1
LVD401 32404-28-7/ 32483-30-0
3-Acetyl-L-tyrosine Hydrochloride
Levodopa Impurity 2
LVD402 55-59-4
3,4-Dimethoxyphenylalanine; DL-3,4-Dimethoxyphenylalanine
Levomefolate
151533-22-1 / Levomefolate
LVM100 N-[4-[[[(6S)-2-Amino-3,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl]methyl]amino]benzoyl]-L-glutamic
31690-09-2
Acid Calcium Salt
Lidocaine
Lidocaine
LDC100 137-58-6
Anestacon ; 2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide
Lidocaine EP Impurity A
LDC201 87-62-7
Bupivacaine EP Impurity F ; Lidocaine USP Impurity A ; 2,6-Dimethylaniline
Lidocaine EP Impurity B
LDC202 2903-45-9
Lidocaine N-Oxide
Lidocaine EP Impurity C
LDC203 2198-53-0
N-(2,6-Dimethylphenyl)acetamide
LDC204 7729-94-4 Lidocaine - Impurity D (Hydrochloride)
Lidocaine EP Impurity E
LDC205 745798-07-6
Lidocaine USP Impurity E ; Lidocaine Dimer Impurity
Lidocaine EP Impurity F
LDC206 857170-72-0/142713-08-4
Lidocaine 2,3-Dimethyl Analog
Lidocaine EP Impurity G
LDC207 35891-87-3
N-(2,6-dimethylphenyl)-2-((1-methylethyl)amino)acetamide hydrochloride
Lidocaine EP Impurity H
LDC208 1131-01-7 Lidocaine USP Related Compound H ; 2-Chloro-N-
(2,6-dimethylphenyl)acetamide
Lidocaine EP Impurity I
LDC209 17289-54-2/17289-53-1
Page 42
Lidocaine EP Impurity J
LDC210 1012864-23-1/857570-37-7
LDC401 17289-53-1 Lidocaine Impurity I Free
Lidocaine Impurity 1
LDC402 39084-88-3
n-Dichloroacetyl-2,6-Xylidine, 2,2-Dichloro-N-(2,6-dimethylphenyl)acetamide
Linagliptin
Linagliptin
LNG100 668270-12-0 (R)-8-(3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1H-
purine-2,6-dione
Lisinopril
Lisinopril Dihydrate
LSN100 83915-83-7
(S)-1-[N2-(1-Carboxy-3-phenylpropyl)-L-lysyl]-L-proline Dihydrate
Lisinopril EP Impurity B
LSN202 104-15-4
4-methylbenzenesulfonic acid
Lisinopril EP Impurity C
LSN203 328385-86-0
S,S,S-Diketopiperazine (lisinopril related compound A)
Lisinopril EP Impurity D
LSN204 219677-82-4
R,S,S-Diketopiperazine
lobeglitazone
lobeglitazone Impuirty 1
LBG401 607723-69-3
2-((6-(4-methoxyphenoxy)pyrimidin-4-yl)(methyl)amino)ethan-1-ol
lobeglitazone Impuirty 2
LBG402 NA
4-(2-((6-(4-Methoxyphenoxy)pyrimidin-4-yl)(methyl)amino) ethoxy)benzaldehyde
lohexol
lohexol Related Compound A
IOH301 31127-80-7
(5-(Acetylamino)-N,N’-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide)
lohexol Related Compound B

IOH302 76801-93-9
5-Amino-N1,N3-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide,
lohexol Related Compound C

IOH303 76820-34-3
(N,N’-Bis(2,3-dihydroxypropyl)-5-nitro-1,3-benzenedicarboxamide)
Loperamide
Loperamide
LPR100 53179-11-6
4-(4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl)-N,N-dimethyl-2,2-diphenylbutanamide
Page 43
Loperamide EP Impurity C
LPR203 39512-49-7
4-(4-chlorophenyl)piperidin-4-ol
Loratadine
Loratadine
LRT100 79794-75-5 Ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]
pyridin-11-ylidene)-1-piperidinecarboxylate
Loratadine EP Impurity B
LRT202 31251-41-9 Loratadine USP Related Compound C ; 8-Chloro-5,6-dihydro-11H-benzo
[5.6] cyclohepta[1,2-b]pyridin-11-one
Loratadine EP Impurity D
LRT204 100643-71-8
Desloratadine ; Loratadine USP Related Compound A
Loratadine EP Impurity G
LRT207 38092-89-6
N-Methyl Desloratadine ; Loratadine USP Related Compound B
Lorazepam
LRZ302 2958-36-3 LORAZEPAM RELATED COMPOUND B
Lornoxicam
Lornoxicam
LRN100 70374-39-9
6-Chloro-4-hydroxy-2-methyl-N-(pyridin-2-yl)-2H-thieno[2,3-e][1,2]thiazine-3-carboxamide 1,1-dioxide
Losartan
Losartan Base
LSR100 114798-26-4
2-Butyl-4-chloro-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol
Losartan Potassium
LSR101 124750-99-8 2-Butyl-4-chloro-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol
monopotassium salt
Losartan EP Impurity A
LSR201 79047-41-9
2-Butyl-4-chloro-1H-imidazole-5-methanol
LSR204 83857-96-9 Losartan EP Impurity D
Losartan EP Impurity K
LSR211 114798-36-6 Losartan USP RC C ; Losartan Aldehyde ; 2-Butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-
formaldehyde
Lurasidone
Lurasidone
LRS100 367514-87-2 (3aR,4S,7R,7aS)-2-(((1R,2R)-2-((4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)methyl)
cyclohexyl)methyl)hexahydro-1H-4,7-methanoisoindole-1,3(2H)-dione
Page 44
Lurasidone Sulfoxide
LRS401 1809325-45-8
Lurasidone DP4- IMPURITY
Lurasidone Sulfone
LRS402 1644295-09-9/ 1807607-99-3
LURASIDONE DP5- IMPURITY
Lurasidone Enantiomer
(3aR,4S,7R,7aS)-2-{(1S,2S)-2-[4-(1,2-Benzisothiazol-3-yl)piperazin-1-yl methyl] cyclohexylmethyl}hexahydro-
LRS403 1448443-35-3 4,7-methano-2H-isoindole-1,3-dione Hydrochloride;(3aR,4S,7R,7aS)-2-(((1S,2S)-2-((4-(Benzo[d]isothiazol-3-
yl)piperazin-1-yl)methyl)cyclohexyl)methyl)hexahydro-1H-4,7-methanoisoindole-1,3(2H)-dione
Hydrochloride
Lurasidone N oxide
(3aR,4S,7R,7aS)-2-[[(1R,2R)-2-[[4-(1,2-Benzisothiazol-3-yl)-1-oxido-1-
LRS404 1574569-32-6
piperazinyl]methyl]cyclohexyl]methyl]hexahydro-4,7-methano-1H-isoindole-1,3(2H)-dione;Lurasidone
Piperazine N-Oxide
Lurasidone amine
LRS405 1260138-03-1
N-[1R,2R-(2-Methylamino)cyclohex-1-yl)methyl]-N’-(1,2-benzisothiazol-3-yl)piperazine
Lurasidone dimer impurity

LRS406 2518442-98-1
(1R,2R)-1,2-bis((4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)methyl)cyclohexane
Lurasidone impurity 1
LRS407 186204-37-5
(3aR,7aR)-4'-(benzo[d]isothiazol-3-yl)octahydrospiro[isoindole-2,1'-piperazin]-2-ium methanesulfonate
Lurasidone impurity 2
LRS408 186204-35-3
(1R,2R)-1, 2-bis (methane sulfonyloxy methyl)Cyclohexane
Mefenamic
acid
MFN100 61-68-7 Mefenamic acid
MFN201 87-59-2 Mefenamic acid EP impurity A
MFN203 118-91-2 Mefenamic acid EP impurity C
MFN204 65-85-0 Mefenamic acid EP impurity D
Melantonin
Melantonin
MLT100 73-31-4
N-(2-(5-methoxy-1H-indol-3-yl)ethyl)acetamide
Melantonin USP Related Compound A

MLT301 608-07-1
2-(5-methoxy-1H-indol-3-yl)ethan-1-amine
Page 45
Melitracen
MLR100 10563-70-9 Melitracen hydrochloride
Meloxicam
Meloxicam
MLX100 71125-38-7 4-hydroxy-2-methyl-N-(5-methylthiazol-2-yl)-2H-benzo[e][1,2]thiazine-
3-carboxamide 1,1-dioxide
Meloxicam EP Impurity A
MLX201 24683-26-9 Meloxicam USP Related Compound A ;
ethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide
Meloxicam EP Impurity B
MLX202 7305-71-7
Meloxicam USP Related Compound B ; 5-methylthiazol-2-amine
Meloxicam EP Impurity C
MLX203 1262333-25-4 Methyl-meloxicamc USP, N-[(2Z)-3,5-dimethylthiazol-2(3H)-ylidene]-4-hydroxy-2-methyl-2H-1,2-
benzothiazine-3-carboxamide 1,1-dioxide
Meloxicam EP Impurity D
MLX204 1331636-17-9 Meloxicam USP RC D; N-[(2Z)-3-ethyl-5-methylthiazol-2(3H)-ylidene]-4-hydroxy-2-methyl-2H-1,2-
benzothiazine-3-carboxamide 1,1-dioxide
Meloxicam EP Impurity E
MLX205 35511-15-0
methyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide
Meloxicam EP Impurity F
MLX206 118854-48-1 Meloxicam USP Related Compound C ;
isopropyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide
Memantine
Memantine HCl
MNT100 41100-52-1
3,5-Dimethyltricyclo[3.3.1.13,7]decan-1-amine hydrochloride
Memantine Related Compound A

MNT301 702-79-4
(1r,3r,5s,7s)-1,3-dimethyladamantane
Memantine Related Compound B

MNT302 707-37-9
(1r,3R,5S,7r)-3,5-dimethyladamantan-1-ol
Memantine Related Compound C

MNT303 707-36-8
(1r,3R,5S,7r)-1-chloro-3,5-dimethyladamantane
Memantine Related Compound D

MNT304 941-37-7
(1r,3R,5S,7r)-1-bromo-3,5-dimethyladamantane
Memantine Related Compound E

MNT305 351329-88-9
N-((1r,3R,5S,7r)-3,5-dimethyladamantan-1-yl)formamide
Page 46
Acetyl memantine
MNT401 19982-07-1
N-((1r,3R,5S,7r)-3,5-dimethyladamantan-1-yl)acetamide
1-Amino -3-Methyladmantane HCl

MNT402 33103-93-4
(1s,3s,5R,7S)-3-methyladamantan-1-amine hydrochloride
Mesalazine
Mesalazine
MSL100 89-57-6
5-Amino-2-hydroxybenzoic acid. ; Mesalamine
Mesalazine EP Impurity A
MSL201 123-30-8
4-aminophenol, Mesalamine EP Impurity A
Mesalazine EP Impurity B
MSL202 591-27-5
3-aminophenol, Mesalamine EP Impurity B
Mesalazine EP Impurity C
MSL203 95-55-6
2-aminophenol.; Mesalamine EP Impurity C
Mesalazine EP Impurity D
MSL204 99-05-8
3-aminobenzoic acid.; Mesalamine EP impurity D
Mesalazine EP Impurity E
MSL205 65-49-6 4-amino-2-hydroxybenzoic acid (4-aminosalicylic acid).;
Mesalamine EP Impurity E
Mesalazine EP Impurity F
MSL206 570-23-0 3-amino-2-hydroxybenzoic acid (3-aminosalicylic acid).;
Mesalamine EP Impurity F
Mesalazine EP Impurity G
MSL207 490-79-9
2,5-dihydroxybenzoic acid.; Mesalamine Ep Impurity G
Mesalazine EP Impurity H
MSL208 69-72-7
2-hydroxybenzoic acid (salicylic acid).; Mesalamine EP Impurity H
Mesalazine EP Impurity I
MSL209 3147-53-3 2-hydroxy-5-(phenyldiazenyl)benzoic acid (phenylazosalicylic acid).;
Mesalamine EP Impurity I
Mesalazine EP Impurity J
MSL210 112725-89-0
3,5-diamino-2-hydroxybenzoic acid (3,5-diaminosalicylic acid).; Mesalamine EP Impurity J
Mesalazine EP Impurity K
MSL211 142-04-1
aniline hydrochloride
Mesalazine EP Impurity L
MSL212 118-91-2
2-chlorobenzoic acid.; Mesalamine EP Impurity L
Mesalazine EP Impurity M
MSL213 2516-96-3
2-chloro-5-nitrobenzoic acid,.; Mesalamine EP Impurity M
Mesalazine EP Impurity N
MSL214 96-97-9 2-hydroxy-5-nitrobenzoic acid (5-nitrosalicylic acid). ;
Mesalamine EP Impurity N
Page 47
Mesalazine EP Impurity O
MSL215 121-57-3
4-aminobenzenesulfonic acid (sulfanilic acid).; Mesalamine EP Impurity O
Mesalazine EP Impurity Q
MSL217 3970-35-2
2-chloro-3-nitrobenzoic acid. ; Mesalamine EP Impurity Q
Mesalazine EP Impurity R
MSL218 85-38-1 2-hydroxy-3-nitrobenzoic acid (3-nitrosalicylic acid). ;
Mesalamine EP Impurity R
Metamizole
Metamizole Sodium Monohydrate
MTZ100 5907-38-0
Methanesulfonic acid, [(2,3-dihydro-1,5-dimethyl-3-oxo-2-phenyl-1H-pyrazol-4-yl)methylamino]
Metamizole EP Impurity A
MTZ201 1672-58-8
4-(formylamino)-1,5-dimethyl-2-phenyl-2,3-dihydro-1H-pyrazol-3-one ; 4-Formylamino Antipyrine
Metamizole EP Impurity B
MTZ202 83-07-8
4-Aminophenazone ; 4-amino-1,5-dimethyl-2-phenyl-2,3-dihydro-1H-pyrazol-3-one ; 4-Aminophenazone
519-98-2/ 856307-27-2 (Hcl Metamizole EP Impurity C

MTZ203
salt) 1,5-dimethyl-4-(methylamino)-2-phenyl-2,3-dihydro-1H-pyrazol-3-one ;4-Methylamino Antipyrine
Metamizole EP Impurity D
MTZ204 58-15-1
4-(dimethylamino)-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one ; 4-Dimethylamino Antipyrine
Metamizole EP Impurity E
MTZ205 117-38-4/129-89-5 Dipirone Impurity E ; ((1,5-dimethyl-3-oxo-2-phenyl-2,3-dihydro-1H-pyrazol-4-yl)amino)methanesulfonic acid
Metformin
MTF100 1115-70-4 Metformin HCl
Metformin EP Impurity A
MTF201 461-58-5
Metformin USP RC A ; 1-Cyanoguanidine
Metformin EP Impurity B
MTF203 2959-04-08
Guanylmelamine HCl ; (4,6-Diamino-1,3,5-triazin-2-yl)guanidine HCl
Metformin EP Impurity D
MTF204 108-78-1
Melamine ; 1,3,5-Triazine-2,4,6-triamine
Metformin EP Impurity E
MTF205 1609-00-3/1674-62-0
N-Methyl-imidodicarbonimidic Diamide HCl
Methyltestoste
rone
Methyltestosterone
MTS100 58-18-4
17-Hydroxy-17-methyl-3-keto-androstene-4
Page 48
Metolazone
Metolazone
MTL100 17560-51-9
7-Chloro-1,2,3,4-tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide
Metolazone EP Impurity A
MTL201 50869-25-5
Metolazone USP RC C ; meta-Metolazone ;
Metolazone EP Impurity B
MTL202 28508-63-6
Metolazone USP RC D ;
Metolazone EP Impurity C
MTL203 Metolazone USP RC A ; Desmethyl metolazone ;
7-Chloro-1,2,3,4-tetrahydro-2-methyl-4-oxo-3-phenyl-6-quinazolinesulfonamide
Metolazone EP Impurity D
MTL204 4015-23-0
Metolazone USP RC E ; Didehydrometolazone
Metolazone EP Impurity E
MTL205 23380-54-3
Metolazone USP RC B ; Metolazone benzamide analog ;
Metoprolol
MTP100 98418-47-4 Metoprolol Succinate
Metoprolol EP Impurity A
MTP201 109632-08-8
Metoprolol USP Related Compound A
Metoprolol EP Impurity B
MTP202 56718-71-9
4-(2-Methoxyethyl)phenol
Metoprolol EP Impurity C
MTP203 29122-74-5 Metoprolol USP Related Compound C ;
4-[(2RS)-2-Hydroxy-3-[(1-methylethyl)amino]propoxy]benzaldehyde
Metoprolol EP Impurity D
MTP204 62572-90-1
(2RS)-3-[4-(2-Methoxyethyl)phenoxy]propane-1,2-diol
Metoprolol EP Impurity F
MTP206 7695-63-8
(2RS)-1-[(1-Methylethyl)amino]-3-phenoxypropan-2-ol
Metoprolol EP ImpurityG
MTP207 501-94-0
2-(4-Hydroxyphenyl)ethanol
Metoprolol EP Impurity O
MTP215 1486464-40-7 Metoprolol USP Related Compound D ; 1,1-[(1-Methylethyl)imino]bis[3-[4-(2-methoxyethyl)phenoxy] propan-
2-ol] Hydrochloride
Metoprolol USP Related Compound B

MTP302 56718-76-4
(+/-)1-Chloro-2-hydroxy-3-[4-(2-methoxyethyl)phenoxy]-propane
Metronidazole
Page 49
Metronidazole
MTR100 443-48-1
2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethan-1-ol
Metronidazole EP impurity A
MTR201 696-23-1
2-methyl-5-nitro-1H-imidazole
Metronidazole EP impurity B
MTR202 3034-38-6
4-nitro-1H-imidazole
Metronidazole EP impurity C
MTR203 5006-69-9
2-(4-nitro-1H-imidazol-1-yl)ethan-1-ol
Metronidazole EP impurity D
MTR204 5006-68-8
2-(5-nitro-1H-imidazol-1-yl)ethan-1-ol
Metronidazole EP Impurity E
MTR205 705-19-1
2-(2-Methyl-4-nitro-1H-imidazol-1-yl)ethan-1-ol
Metronidazole EP Impurity F
MTR206 16156-94-8
2-(2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethoxy)ethan-1-ol
Metronidazole EP impurity G
MTR207 1010-93-1
2-(2-methyl-5-nitro-1H-imidazol-1-yl)acetic acid
Milnacipran
Milnacipran
MLN100 92623-85-3
(1S,5R)-1-phenyl-3-oxabicyclo[3.1.0]hexan-2-one
MLN401 63106-93-4 1-Phenyl-3-oxabicyclo[3.1.0]hexan-2-one
Mirabegron
Mirabegron
MRB100 223673-61-8
2-Amino-N-[4-[2-[[(2R)-2-hydroxy-2-phenylethyl]amino]ethyl]phenyl]-4-thiazoleacetamide
Mirabegron Impurity A
MRB401 29676-71-9
2-(2-aminothiazol-4-yl)acetic acid
Mirabegron Impurity B
MRB402 1684453-05-1
2-Oxo Mirabegron
MIRABEGRON IMPURITY MRBRC4

MRB403
(R)-2-(2-Aminothiazol-4-yl)-N-(4-(2-((2-hydroxy-2-phenyethyl)(methyl)amino)ethyl)phenyl)acetamide
Mirabegron EP Impurity G/ Mirabegron Stage-1 Impurity

MRB 207/ MRB404 521284-19-5
(R)-2-hydroxy-N-(4-nitrophenethyl)-2-phenylacetamide
Mirabegron EP Impurity F/ Mirabegron Stage- 2 Impurity

MRB206/ MRB405 223673-34-5
(R)-2-((4-Nitrophenethyl)amino)-1-phenylethan-1-ol
Mirabegron EP Impurity B/ Mirabegron Stage-3 Impurity

MRB406/MRB202 391901-45-4/521284-22-0
(R)-2-((4-Aminophenethyl)amino)-1-phenylethan-1-ol/ Mirabegron Impurity C
Mirabegron EP Impurity C/ Mirabegron Deshydroxy Impurity

MRB407/203 1581284-82-3/1581284-79-8
2-(2-Aminothiazol-4-yl)-N-(4-(2-(phenethylamino)ethyl)phenyl)acetamide
Mirabegron EP Impurity A
MRB201 1796931-48-0
Mirabegron Enantiomer
Page 50
Mirabegron Impurity 2/ Mirabegron EP Impurity D
MRB409 2489747-26-2 (R)-2-(2-Aminothiazol-4-yl)-N-(4-(2-((4-(2-((2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)amino)-2-
oxoethyl)thiazol-2-yl)acetamide
Mirabegron Impurity 3
MRB410 2036283-13-1
2-(2-(2-(2-Aminothiazol-4-yl)acetamido)thiazol-4-yl)acetic acid
Mirabegron Impurity 4
MRB411 1684452-83-2 (R)-2-(2-Aminothiazol-4-yl)-N-(4-(2-(2-aminothiazol-4-yl)acetamido)phenethyl)-N-(2-hydroxy-2-
phenylethyl)acetamide
Mirabegron EP Impurity E
MRB205 29968-78-3/ 24954-67-4
2-(4-Nitrophenyl)ethanamine Hydrochloride
MRB209 1892-57-5 Mirabegron - Impurity I (Freebase)
MRB501 53266-94-7 Mirabegron Impurity I
MRB502 1603-91-4 Mirabegron Impurity II
MRB503 1310279-36-7 Mirabegron Impurity III
Mirabegron Impurity IV
MRB504 1154949-80-0
2-Phenylethanamine,N-(4-nitrophenethyl);[2-(4-Nitrophenyl)ethyl](2-phenylethyl)amine
Montelukast
Montelukast/ Montelukast Sodium

MNK100 158966-92-8/151767-02-1 (R-(E))-1-(((1-(3-(2-(7-Chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-
methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic acid
Montelukast EP Impurity B
MNK202 918972-54-0
Montelukast USP Related Compound F ; Montelukast Methylstyrene ; Anhydro Montelukast
Montelukast EP Impurity C
MNK203 909849-96-3
Montelukast USP Related Compound A ; Montelukast Sulfoxide
MNK401 959235-68-8 Montelukast (3RS)-Hydroxy Propanol
MNK402 2125943-58-8 Montelukast EP Impurity D / E
MNK403 184764-13-4 Montelukast KSM-I Keto impurity
Moxifloxacin
Moxifloxacin HCl
MXF100 186826-86-8 1-Cyclopropyl-6-fluoro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-
dihydroquinoline-3-carboxylic acid hydrochloride
Moxifloxacin EP Impurity A
MXF201 151213-15-9
Moxifloxacin USP RC A ; 8-Desmethoxy-8-Fluoro Moxifloxacin ; Moxifloxacin Difluoro Analog;
Mycophenolate Mofetil
Page 51
Mycophenolate Mofetil
6-[(7-Hydroxy-5-methoxy-4-methyl-1-oxo-3H-isobenzofuran-6-yl)]-4-methyl-hex-4-enoic acid 2-
MCP100 128794-94-5
morpholinoethyl ester ; 2-(Morpholin-4-yl)ethyl (4E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-
dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate
Mycophenolate Mofetil EP Impurity E

MCP205 31858-66-9
Mycophenolic Acid Methyl Ester
Mycophenolate Mofetil EP Impurity F
MCP206 24280-93-1
Mycophenolic Acid
Nabumetone
Nabumetone EP Impurity A
NBM201 343272-52-6
3-(6-methoxynaphthalen-2-yl)-5-methylcyclohexanone
Nabumetone EP Impurity B
NBM202 343272-51-5
(5RS)-5-(6-methoxynaphthalen-2-yl)-3-methylcyclohex-2-enone
Nabumetone EP Impurity C
NBM203 65726-24-1
(2RS)-4-(6-methoxynaphthalen-2-yl)butan-2-ol
Nabumetone EP Impurity D
NBM204 127053-22-9
USP Related Compound A ; Dehydro Nabumetone ;
Nabumetone EP Impurity F
NBM206 29619-45-2
6,6'-dimethoxy-2,2'-binaphthalenyl
Nabumetone Impurity 1
NBM401 218768-11-7
(3Z)-4-Hydroxy-4-(6-methoxy-2-naphthalenyl)-3-buten-2-one
Naproxen
Naproxen
NPR100 22204-53-1
(S)-6-Methoxy-α-methyl-2-naphthaleneacetic Acid ; Diocodal ; d-2-(6-Methoxy-2-naphthyl)propionic Acid
Naproxen EP Impurity E
NPR205 26159-35-3
Methyl (2S)-2-(6-methoxynaphthalen-2-yl)propanoate
Naproxen EP Impurity L
NPR212 3900-45-6
1-(6-methoxynaphthalen-2-yl)ethan-1-one
Naproxen EP Impurity N
NPR214 5111-65-9
2-Bromo-6-methoxynaphthalene
Naproxen EP Impurity O
NPR215 2471-70-7
Naproxen USP Related Compound A ; Naproxen Carboxylic Impurity ; 6-Methoxy-2-naphthoic acid
Nateglinide
Nateglinide
NTG100 105816-04-4
(2R)-2-({[trans-4-(1-methylethyl)cyclohexyl]carbonyl}amino)-3-phenylpropanoic acid
NTG206 944746-48-9 NATEGLINIDE IMPURITY-F
NTG207 187728-85-4 Nateglinide ethyl ester
NTG401 105746-45- 0 Nateglinide Impurity 1
Nebivolol
Page 52
Nebivolol hydrochloride
NBV100 152520-56-4 α,α’-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol]; α,α’-
(Iminodimethylene)bis[6-fluoro-2-chromanmethanol] Hydrochloride
N-Formyl Nebivolol
NBV401 NA
N,N-bis(2-(6-fluorochroman-2-yl)-2-hydroxyethyl)formamide
NBV402 1391051-68-5
N,N-bis(2-(6-fluorochroman-2-yl)-2-hydroxyethyl)nitrous amide
Nefopam
NFP100 13669-70-0
3,4,5,6-Tetrahydro-5-methyl-1-phenyl-1H-2,5-benzoxazocine
Nefopam Impurity 1
NFP401 85-52-9
2-Benzoylbenzoic acid
Nefamide, Nefopam Impurity 2
NFP402 24833-47-4
2-Benzoyl-N-(2-hydroxyethyl)-N-methylbenzamide
Nefopam Impurity A, Nefopam Impurity 3

NFP403 60725-36-2
2-((2-(Hydroxy(phenyl)methyl)benzyl)(methyl)amino)ethan-1-ol
Nicorandil
Nicorandil
NCR100 65141-46-0
2-[(Pyridin-3-ylcarbonyl)amino]ethyl nitrate
Nicorandil EP Impurity A
NCR201 65141-47-1
2-(isonicotinamido)ethyl nitrate ; 2-[(pyridin-4-ylcarbonyl)amino]ethyl nitrate
Nifedipine EP impurity A
NFD201 67035-22-7
dimethyl 2,6-dimethyl-4-(2-nitrophenyl)pyridine-3,5-dicarboxylate (nitrophenylpyridine analogue)
Nifedipine
Nifedipine
NFD100 21829-25-4
3,5-dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
Nifedipine EP impurity B
NFD202 50428-14-3 Nifedipine nitrosophenylpyridine analog ; Dimethyl 4-(2-nitrosophenyl)-2,6-dimethylpyridine-3,5-
dicarboxylate
Nifedipine EP impurity C
NFD203 111304-31-5
methyl 2-(2-nitrobenzylidene)-3-oxobutanoate
Octenidine dihydrochloride
OCT100 70775-75-6/71251-02-0
N,N′-(decane-1,10-diyldi-1(4H)-pyridyl-4-ylidene)bis(octylammonium) dichloride
Olanzapine
Olanzapine
OLN100 132539-06-1
2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine
Olanzapine EP Impurity A
OLN201 138564-59-7
Olanzapine USP RC A ; 5-methyl-2-((2-nitrophenyl)amino)thiophene-3-carbonitrile
Page 53
Olanzapine Amino Impurity
OLN401 873895-41-1
2-(2-Aminoanilino)-5-methylthiophene-3-carbonitrile
2-Amino-5-methyl-3-thiophenecarbonitrile
OLN402 138564-58-6
2-Amino-5-methyl-3-thiophenecarbonitrile
Olmesartan
Olmesartan Medoxomil
OLM100 144689-63-4 (5-Methyl-2-oxo-2H-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-({4-[2-(2H-1,2,3,4-tetrazol-5-
yl)phenyl]phenyl}methyl)-1H-imidazole-5-carboxylate
Olmesartan EP Impurity A
OLM201 144689-24-7
Olmesartan Acid
Olmesartan EP Impurity B
OLM202 849206-43-5
Olmesartan USP RC A ; Olmesartan gama-Lactone ; Olmesartan Lactone ;
Olmesartan EP Impurity C
OLM203 879562-26-2 Dehydro Olmesartan Medoxomil ; Anhydro Olmesartan Medoxomil ; Olmesartan Medoxomil Olefinic
Impurity (USP)
Olmesartan EP Impurity D
OLM204 1020157-01-0
N2-Trityl Olmesartan Medoxomil
Olmesartan Ethyl Ester

OLM401 144689-23-6 4-(2-Hydroxypropan-2-yl)-2-propyl-1-({4-[2-(2H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)-1H-imidazole-5-
carboxylic acid ethyl ester
Olmesartan Imidazole Diacid Impurity

OLM402 58954-23-7
2-Propyl-1H-imidazole-4,5-dicarboxylic acid
Olmesartan Imidazole Diethyl Ester Impurity
OLM403 144689-94-1
2-Propyl-1H-imidazole-4,5-dicarboxylic acid diethyl ester
Olmesartan Imidazole Ethyl Ester Impurity

OLM404 144689-93-0
Ethyl 4-(1-hydroxy-1-methylethyl)-2-propyl-imidazole-5-carboxylate
Olmesartan Medoxomil Methyl Ether

OLM405 896419-17-3
Olmesartan Medoxomil O-Methyl Analog
OLM406 NA Olmesartan Methyl Ether with Trityl

Olmesartan Methyl Ketone
OLM407 1227626-45-0
Olmesartan Acetyl Analog
Olmesartan Anhydro Acid
OLM408 172875-98-8
Olmesartan Methylvinyl Acid ; Olmesartan Olefinic Acid, Olmesartan Dehydro
Olmesartan Anhydro Acid Ethyl Ester

OLM409 172875-87-5
Olmesartan Olefinic Acid Ethyl Ester
Olmesartan Medoxomil Ethyl Methyl Analog

OLM410 1378863-74-1 4-(1-Hydroxy-1-methylpropyl)-2-propyl-1-[[2’-(2H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-1H-imidazole-5-
carboxylic Acid (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl Ester
Olmesartan Impurity (N-(Triphenylmethyl)

OLM411 124750-51-2 1H-Tetrazole, 5-[4'-(bromomethyl)[1,1'-biphenyl]-2-yl]-1-(triphenylmethyl)
Page 54
N1-Trityl Olmesartan Medoxomil
OLM412 144690-92-6 4-(1-Hydroxy-1-methylethyl)-2-propyl-1-[[2’-[1-(triphenylmethyl)-1H-tetrazol-5-yl][1,1’-biphenyl]-4-yl]methyl]-
1H-Imidazole-5-carboxylic Acid (5-Methyl-2-oxo-1,3-dioxol-4-yl)Methyl Ester
Olmesartan Ethyl Ester Trityl Impurity

1H-Imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-[1-(triphenylmethyl)-1H-tetrazol-
OLM413 144690-33-5
5-yl][1,1'-biphenyl]-4-yl]methyl]-, ethyl ester' Ethyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[4-[2-
(trityltetrazol-5-yl)phenyl]phenyl]methylimidazole-5-carboxylateTritylolmesartan ethyl ester
Olmesartan Medoxomil Impurity 5

OLM1414 80841-78-7
(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl Chloride; 4-Chloromethyl-5-methyl-2-oxo-1,3-dioxole
Olmesartan Impurity 3
OLM415 172875-53-5
ethyl 4-(2-hydroxybutan-2-yl)-2-propyl-1H-imidazole-5-carboxylate
OLM416 1443544-27-1
4,5-bis(chloromethyl)-1,3-dioxol-2-one
OLM417 144690-07-3
ethyl 4-acetyl-2-propyl-1H-imidazole-5-carboxylate
OLM418 157356-73-5
ethyl 4-(prop-1-en-2-yl)-2-propyl-1H-imidazole-5-carboxylate
Olmesartan Dimer Ester

4-(1-Hydroxy-1-methylethyl)-2-propyl-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-
OLM419 1040250-19-8
carboxylic acid 1-[5-carboxy-2-propyl-1-[[2'-(2H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-1H-imidazol-4-yl]-
1-methylethyl ester
OLOPATADINE RELATED COMPOUND C

OLP303 55453-87-7
2-(11-Oxo-6,11-dihydrodibenzo[b,e]oxepin-2-yl)acetic acid,
Omeprazole
Omeprazole
OMP100 95510-70-6 (Na salt) & 73590-58-6Sodium 5-methoxy-2-[(RS)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl] sulphinyl]-1H-benzimidazole
monohydrate
Omeprazole EP Impurity A
OMP201 37052-78-1
Esomeprazole EP Impurity A ; 5-Methoxy-1H-benzimidazole-2-thiol
Omeprazole EP Impurity C
OMP203 73590-85-9
Esomeprazole EP Impurity C ; Omeprazole Sulfide
Omeprazole EP Impurity D
OMP204 88546-55-8
Omeprazole sulphone ; Esomeprazole USP Related Compound A Omeprazole Related Compound A,
Omeprazole EP Impurity E
OMP205 176219-04-8
Omeprazole USP RC E ; Esomeprazole EP Impurity E ; Omeprazole N-Oxide
Omeprazole Impurity F and G Mixture

OMP206-207 125656-82-8/125656-83-9 8(9)-Methoxy-1,3-dimethyl-12-thioxopyrido[1’,2’:3,4]imidazo[1,2-a]benzimidazol-2-(12H)-one (Mixture of
Regioisomers);Omeprazole Related Compound F&G (US
Omeprazole EP Impurity I
OMP209 158812-85-2
Omeprazole USP RC I
Omeprazole EP Impurity 1
OMP401 86604-75-3
2-Chloromethyl-3,5-dimethyl-4-methoxypyridine HCl
Page 55
Omeprazole EP Impurity 2
OMP402 89352-76-1
Mixture of N-Methyl 5-Methoxy & N-Methyl 6-Methoxy Analog
Ondansetron
Ondansetron Hydrocloride
OND100 103639-04-9 9-methyl-3-((2-methyl-1H-imidazol-1-yl)methyl)-1,2,3,9-tetrahydro -4H-carbazol-4-one hydrochloride
dihydrate
153139-56-1/ Ondansetron EP Impurity A

OND201 Ondansetron Related Compound A,3-((dimethylamino)methyl)-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-
119812-29-2
one
Ondansetron EP Impurity C
OND203 27387-31-1 Ondansetron Related Compound C,
9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one
Ondansetron EP Impurity D
OND204 99614-64-9
Related compound D, 9-methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-one
OND 288-32-4 Ondansetron EP Impurity E

Ondansetron EP Impurity F
OND206 693-98-1
2-methyl-1H-imidazole
Ondansetron EP Impurity G
OND207 99614-03-6
3-((1H-imidazol-1-yl)methyl)-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one
Ondansetron EP Impurity H
OND208 99614-14-9
3-((2-methyl-1H-imidazol-1-yl)methyl)-1,2,3,9-tetrahydro-4H-carbazol-4-one
OXACEPROL
OCP100 33996-33-7 (2S,4R)-1-acetyl-4-hydroxypyrrolidine-2-carboxylic acid
Oxcarbazepine
Oxcarbazepine
OXC100 28721-07-5
10-oxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide
Oxcarbazepine EP Impurity A
OXC201 298-46-4
5H-dibenzo[b,f]azepine-5-carboxamide
Oxcarbazepine EP Impurity C
OXC203 21737-58-6
Oxcarbazepine Related Compound E; 5,11-dihydro-10H-dibenzo[b,f]azepin-10-one
Oxcarbazepine EP Impurity E
OXC205 256-96-2
5H-dibenzo[b,f]azepine, Iminostilbene
Oxybendazole
Oxybendazole
OXY100 20559-55-1
(5-Propoxy-1H-benzimidazol-2-yl)carbamic Acid Methyl Ester
Ozanimod
Ozanimod
OZN100 1306760-87-1 (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-
isopropoxybenzonitrile Hydrochloride
Page 56
Ozanimod Ketone Impurity
OZN401 2251699-84-8
2-Isopropoxy-5-(3-(1-oxo-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)benzonitrile
Ozanimod Alcohol Impurity

OZN402 1201447-05-3
5-(3-(1-hydroxy-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile
Ozanimod R Isomer
OZN403 (R)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-
isopropoxybenzonitrile hydrochloride
Ozanimod Impurity 1
OZN501
tert-butyl (1R)-4-(5-(3-cyano-4-isopropoxyphenyl)-1,2,4-oxadiazol-3-yl)-2,3-dihydro-1H-inden-1-ylcarbamate
Pantoprazole
Pantoprazole
PNT100 102625-70-7
5-(difluoromethoxy)-2-(((3,4-dimethoxypyridin-2-yl)methyl)sulfinyl)-1H-benzo[d]imidazole
Pantoprazole EP Impurity A
PNT201 127780-16-9 Pantoprazole Related Compound A ; 6-(difluoromethoxy)-2-(((3,4-dimethoxypyridin-2-yl)methyl)sulfonyl)-1H-
benzo[d]imidazole
Pantoprazole EP Impurity B
PNT202 102625-64-9 Pantoprazole Related Compound B ; 5-(difluoromethoxy)-2-(((3,4-dimethoxypyridin-2-yl)methyl)thio)-1H-
benzo[d]imidazole
Pantoprazole EP Impurity C
PNT203 97963-62-7
Pantoprazole Related Compound C ; 5-(difluoromethoxy)-1H-benzo[d]imidazole-2-thiol
Pantoprazole Related Compound D and F

PNT304-305 NA
5-(difluoromethoxy)-2-(((3,4-dimethoxypyridin-2-yl)methyl)sulfinyl)-1-methyl-1H-benzo[d]imidazole
Pantoprazole Chloro Impurity

PNT401 72830-09-2
2-(chloromethyl)-3,4-dimethoxypyridine hydrochloride
PNT402 953787-60-5 2-(((6-(difluoromethoxy)-1H-benzo[d]imidazol-2-yl)sulfinyl)methyl)-3,4-dimethoxypyridine 1-oxide
Pantoprazole Sulfone N-Oxide

PNT403 953787-55-8
2-(((5-(difluoromethoxy)-1H-benzo[d]imidazol-2-yl)sulfonyl)methyl)-3,4-dimethoxypyridine 1-oxide
Papaverine
Papaverine hydrochloride
PVR100 61-25-6
1-(3,4-Dimethoxybenzyl)-6,7-dimethoxyisoquinoline hydrochloride
Methylparaben
PRB100 99-76-3 methyl 4-hydroxybenzoate
Butylparaben Impurity E
PRB401 4247-02-3
isobutyl 4-hydroxybenzoate
Propylparaben
PRB402 94-13-3
propyl 4-hydroxybenzoate
Paracetamol
Paracetamol
PRC100 103-90-2
N-(4-hydroxyphenyl)acetamide
Page 57
Paracetamol EP Impurity A
PRC201 614-80-2
Acetaminophen Related Compound C, N-(2-hydroxyphenyl)acetamide
Paracetamol EP Impurity B
PRC202 1693-37-4
Acetaminophen Related Compound B, N-(4-hydroxyphenyl)propionamide
Paracetamol EP Impurity C
PRC203 3964-54-3
N-(3-chloro-4-hydroxyphenyl)acetamide
Paracetamol EP Impurity D
PRC204 103-84-4
Acetaminophen Related Compound D, N-phenylacetamide
Paracetamol EP Impurity E
PRC205 99-93-4
1-(4-hydroxyphenyl)ethanone
Paracetamol EP Impurity F
PRC206 100-02-7
4-nitrophenol
Paracetamol EP Impurity G
PRC207 198712-64-0
(E)-1-(4-hydroxyphenyl)ethanone oxime
Paracetamol EP Impurity H
PRC208 2623-33-8
4-acetamidophenyl acetate
Paracetamol EP Impurity I
PRC209 118-93-4
1-(2-hydroxyphenyl)ethan-1-one
Paracetamol EP Impurity J
PRC210 539-03-7
Acetaminophen Related Compound J, N-(4-chlorophenyl)acetamide
Paracetamol EP Impurity K
PRC211 123-30-8
4-aminophenol
Parbendazole
Parbendazole
PRN100 14255-87-9
Methyl (5-butyl-1H-benzoimidazol-2-yl)carbamate, Methyl 5(6)-butyl-2-benzimidazolecarbamate
Penicillin
PNC100 87-08-1
Penicillin V, Phenoxymethylpenicillinic acid ;
Phenoxymethylpenicillin EP Impurity B
PNC202 122-59-8
Glycolic acid phenyl ether ; 2-phenoxyacetic acid
6-Aminopenicillanic Acid
PNC401 551-16-6 (2S,5R,6R)-6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-
2-carboxylic acid
Pheniramine
Pheniramine Maleate
PHR100 132-20-7
N,N-Dimethyl-3-phenyl-3-(pyridin-2-yl)propan-1-amine maleate
Pheniramine Impurity 1
PHR401 NA
2-phenyl-4-(dimethylamino)-2-(pyridin-2-yl) butanenitrile
Pheniramine Impurity 2
PHR402 5005-36-7
phenyl(pyridin-2-yl)acetonitrile
Phenylephrine
Phenylephrine HCl
PHN100 61-76-7
(αR)-3-Hydroxy-α-[(methylamino)methyl]benzenemethanol Hydrochloride;
Phenylephrine EP Impurity C
PHN203 52093-42-2 / 94240-17-2
Phenylephrine USP Related Compound C ; 1-(3-hydroxyphenyl)-2-(methylamino)ethanone ; phenylephrone
Page 58
Phenylephrine EP Impurity D
PHN204 1367567-95-0/ 71786-67-9 Phenylephrine USP Related Compound D ; (1R)-2-(benzylmethylamino)-1-(3-hydroxyphenyl)ethanol ;
benzylphenylephrine
Phenylephrine EP Impurity E
PHN205 56917-44-3 Phenylephrine Related Compound E ; 2-(benzylmethylamino)-1-(3-hydroxyphenyl)ethanone ;
benzylphenylephrone
Norphenylephrine
PHN401 4779-94-6
DL-Norphenylephrine Hydrochloride, PHENYLEPHRINE HCl IMPURITY A
Phenytoin
Phenytoin Sodium
PHY100 630-93-3
5,5-diphenylimidazolidine-2,4-dione
Pioglitazone
Pioglitazone hydrochloride
PGL100 112529-15-4
(RS)-5-(4-[2-(5-Ethylpyridin-2-yl)ethoxy]benzyl)thiazolidine-2,4-dione hydrochloride
Pioglitazone EP impurity A
PGL201 625853-74-9
5-Hydroxy Pioglitazone Impurity ; Pioglitazone 5-Hydroxy Metabolite
Pioglitazone EP impurity B
PGL202 136401-69-9 /144809-28-9
Didehydro Pioglitazone Impurity ; 5-{4-[2-(5-Ethyl-2-pyridinyl) ethoxy] benzylidene}-2,4-thiazolidinedione
Pioglitazone EP impurity C
PGL203 952188-00-0
Pioglitazone USP RC C ; N-Alkyl Pioglitazone
Pioglitazone Aldehyde Impurity
PGL401 114393-97-4
Pioglitazone Benzaldehyde Impurity
Pioglitazone M1 Metabolite
PGL402 74772-78-4
5-(4-Hydroxybenzyl)-1,3-thiazolidine-2,4-dione
Pioglitazone N-Oxide
PGL403 145350-09-0
5-[[4-[2-(5-Ethyl-2-pyridinyl]ethoxy]phenyl]methyl]-2,4-thiazolidinedione N-oxide
Pioglitazone impurity 1
PGL404 2295-31-0
thiazolidine-2,4-dione
Pioglitazone impurity 2
PGL405 5223-06-3
2-(5-Ethylpyridin-2-yl)ethanol
Pioglitazone impurity
PGL406 103788-60-9
5-(4-Hydroxybenzylidene)thiazolidine-2,4-dione
Pirfenidone
Pirfenidone
PRF100 53179-13-8
5-methyl-1-phenylpyridin-2(1H)-one
Pirfenidone EP Impurity A
PRF201 1603-41-4
5-methylpyridin-2-amine
Pirfenidone EP Impurity B
PRF202 1003-68-5
5-methylpyridin-2(1H)-one
Pirfenidone EP Impurity C
PRF203 108-95-2
phenol
Pirfenidone EP Impurity D
PRF204 108-86-1
Bromobenzene
Piroxicam
Page 59
Piroxicam
PRX100 36322-90-4
4-hydroxy-2-methyl-N-(pyridin-2-yl)-2H-benzo[e][1,2]thiazine-3-carboxamide 1,1-dioxide
Piroxicam EP Impurity A
PRX201 504-29-0
pyridin-2-amine, Piroxicam Related Compound A
Piroxicam EP Impurity D
PRX204 6639-62-9
Methyl (1,1-dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl)acetate, Piroxicam Related Compound D
Piroxicam EP Impurity E
PRX205 24683-20-3
Ethyl (1,1-dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl)acetate
Piroxicam EP Impurity F
PRX206 76508-37-7
1-Methylethyl (1,1-dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl)acetate
Piroxicam EP Impurity G
PRX207 35511-14-9
Methyl 4-hydroxy-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide, Piroxicame Related Compound G
Piroxicam EP Impurity J
PRX210 35511-15-0 Methyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide, Piroxicame Related Compound
J
Piroxicam EP Impurity K
PRX211 24683-26-9
Ethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide
Piroxicam EP Impurity L
PRX212 118854-48-1
1-methylethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide
Pramipexole
PRM100 Pramipexole
(R)-N-Despropyl Pramipexole
PRM401 106092-11-9
(R)-4,5,6,7-Tetrahydro-benzothiazole-2,6-diamine
Prasugrel
Prasugrel Hydrochloride
PRS100 389574-19-0 5-(2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate
hydrochloride
Prasugrel EP Impurity D
PRS204 150322-38-6
Prasugrel Thiolactone ; Prasugrel USP Related Compound D
Prasugrel EP Impurity G
PRS207 1391054-37-7
Prasugrel Diketone ; 1-cyclopropyl-2-(2-fluorophenyl)ethane-1,2-dione
Prasugrel EP Impurity I
PRS209 150322-73-9
1-cyclopropyl-2-(2-fluorophenyl)ethan-1-one
Prasugrel HCl Desacetyloxy Impurity

PRS401 201049-78-7
1-cyclopropyl-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)-2-(2-fluorophenyl) ethan-1-one hydrochloride
Prasugrel Bromobutyryl Impurity

PRS402 1373350-59-4
5-(5-bromo-1-(2-fluorophenyl)-2-oxopentyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate
Prasugrel Hydroxy Thiolactone

PRS403 947502-66-1 Desacetyl hydroxyprasugrel ; 5-(2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl)-7a-hydroxy-5,6,7,7a-
tetrahydrothieno[3,2-c]pyridin-2(4H)-one
Page 60
Prasugrel Impurity 7
PRS404 115473-15-9
5,6,7,7a-tetrahydrothieno[3,2-c]pyridin-2(4H)-one hydrochloride
PRS405 1100905-45-0
1-cyclopropyl-2-(2-fluorophenyl)-2-hydroxyethan-1-one
PRS406 204205-33-4
2-bromo-1-cyclopropyl-2-(2-fluorophenyl)ethan-1-one
Prasugrel Impurity of KSM-ll
PRS407 2091625-61-3
2,2-dibromo-1-cyclopropyl-2-(2-fluorophenyl) ethanone
PRS408 134770-09-5 BROMO(2-FLUROPHENYL)ACETIC ACID
Prednisolone
PRD100 50-24-8 Prednisolone
Pregabalin
Pregabalin
PRG100 148553-50-8
(S)-3-(Aminomethyl)-5-methylhexanoic acid
Pregabalin EP Impurity A
PRG201 181289-23-6
(4S)-4-(2-Methylpropyl)pyrrolidin-2-one
Pregabalin EP Impurity B
PRG202 148553-51-9
USP Pregabalin Related Compound A ; (R)-3-(aminomethyl)-5-methylhexanoic acid
Pregabalin EP Impurity C
PRG203 90-64-2
2-hydroxy-2-phenylacetic acid,(Mandelic acid)
Pregabalin EP Impurity D
PRG204 4118-51-8
1-Methylethyl (2RS)-2-hydroxy-2-phenylacetate
Pregabalin Lactam Impurity
PRG401 61312-87-6
4-isobutylpyrrolidin-2-one, Pregabalin related compound C
Pregabalin Impurity 1/Pregabalin Impurity B
PRG402 75143-89-4
(3-Isobutylglutaric Acid) ; 3-isobutylpentanedioic acid
Pregabalin Impurity 2
PRG403 181289-33-8
Isobutyl-glutamonoamide (R)-3-(2-amino-2-oxoethyl)-5-methylhexanoic acid
Pregabalin Impurity 3
PRG404 181289-15-6
3-(2-amino-2-oxoethyl)-5-methylhexanoic acid
Progesterone
PRT100 Progesterone
PRT202 Progesterone EP Impurity B
PRT203 Progesterone EP Impurity C
Propofol
Propofol
PFL100 2078-54-8
2,6-diisopropylphenol
Propofol EP Impurity C
PFL203 88-69-7
2-(1-methylethyl)phenol
Propofol EP Impurity E
PFL205 2416-95-7
3,3′,5,5′-tetrakis(1-methylethyl)biphenyl-4,4′-diol, Propofol USP Related Compound A
Page 61
Propofol EP Impurity F
PFL206 618-45-1
3-Isopropylphenol
Propofol EP Impurity G
PFL207 141214-18-8
2-(1-methylethoxy)-1,3-bis(1-methylethyl)benzene, Propofol USP Related Compound C
Propofol EP Impurity H
PFL208 99-89-8
4-(1-methylethyl)phenol
Propofol EP Impurity I
PFL209 101-84-8
oxydibenzene
Propofol EP Impurity J
PFL210 1988-11-0
Propofol Related Compound B, 2,6-bis(1-methylethyl)benzene-1,4-dione
Propofol EP Impurity K
PFL211 14366-59-7
Isopropyl 2-Isopropylphenyl Ether, o-Cumenyl Isopropyl Ether
Propofol EP Impurity N
PFL214 13423-73-9
4-hydroxy-3,5-bis(1-methylethyl)benzoic acid
Propranolol
Propranolol EP Impurity A/Propranolol Related Compound A
PRP201 36112-95-5
3-(naphthalen-1-yloxy)propane-1,2-diol
Propranolol EP Impurity B/Propranolol Dimer
PRP202 2172495-51-9 / 83314-78-7
3,3'-(isopropylazanediyl)bis(1-(naphthalen-1-yloxy)propan-2-ol)
Propranolol EP Impurity C
PRP203 17216-10-3
1,3-bis(naphthalen-1-yloxy)propan-2-ol
2-[(1-Naphthalenyloxy)methyl]oxirane
PRP401 2461-42-9
2-[(1-Naphthalenyloxy)methyl]oxirane
Prucalopride
Prucalopride Succinate
PRL100 179474-85-2 4-amino-5-chloro-N-(1-(3-methoxypropyl)piperidin-4-yl)-2,3
-dihydrobenzofuran-7-carboxamide succinate
Prucalopride impurity D
PRL404 182808-04-4
Methyl 4-amino-5chloro-2,3dihydrobenzofuran7-carboxylate
Prucalopride impurity E
PRL405 137211-63-3
Ethyl 4-(4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxamido)piperidine-1-carboxylate
Prucalopride Impurity 1
PRL406 123654-26-2
4-Amino-5-chloro-2,3-dihydrobenzofuran-7-carboxylic acid
Prucalopride Impurity 2
PRL407 1599434-55-5
4-Amino-5-chloro-N-(1-(3-hydroxypropyl)piperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide
Prucalopride impurity A
PRL401 137211-64-4
4-amino-5-chloro2,3-dihydro-N(piperidin4-yl) benzofuran -7carboxamide TFA Salt
Prucalopride impurity B
PRL402 182808-16-8
4-amino-5-chloro-2,3dihydro-1-benzofuran7-carboxamide
Prucalopride impurity C
PRL403 1900715-98-1 Prucalopride N-Oxide ; 4-(4-amino-5-chloro-2,3-dihydrobenzofuran
-7-carboxamido)-1-(3-methoxypropyl)piperidine 1-oxide
Pulegone
PLG100 89-82-7 Pulegone
Page 62
Quetiapine
Quetiapine Fumarate
QTP100 111974-72-2
2-[2-(4-dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol hemifumarate
Quetiapine EP Impurity A
QTP201 844639-07-2
2-[2-(4-Dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethyl acetate
Quetiapine EP Impurity B
QTP202 111974-74-4
Quetiapine USP Related Compound B ; Dibenzo[b,f][1,4]thiazepine-11-yl-piperazine dihydrochloride
Quetiapine EP Impurity D
QTP204 945668-94-0
Quetiapine Dimer Impurity ; Quetiapine Bis(dibenzothiazepinyl) piperazine Impurity (USP)
Quetiapine EP Impurity G
QTP207 3159-07-7
Quetiapine USP Related Compound G ; Dibenzo[b,f][1,4]thiazepine-11(10-H)-one
Quetiapine EP Impurity H
QTP208 1076199-40-0
Quetiapine N-Oxide ; 2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol N-oxide
Quetiapine EP Impurity I
QTP209 329218-14-6/ 329216-67-3
Quetiapine Desethoxy Impurity (USP) ; Quetiapine Alcohol Impurity
Quetiapine EP Impurity P HCl Salt
QTP216 NA
Quetiapine N-Ethyl Impurity, 11-(4-Ethylpiperazin-1-yl)dibenzo[b,f][1,4]thiazepine hydrochloride
Quetiapine EP Impurity Q
QTP217 NA
4-(Dibenzo[b,f][1,4]thiazepin-11-yl)-1,1-bis(2-(2-hydroxyethoxy)ethyl) piperazin-1-ium Iodide
Quetiapine DBTC Impurity

QTP401 13745-86-3
Dibenzo[b,f][1,4]thiazepine-11-yl-chloride ; 11-Chloro-dibenzo[b,f][1,4] thiazepine
Quetiapine DBTP N-Methyl Impurity
QTP402 1977-09-9
11-(4-Methylpiperazin-1-yl)-dibenzo[b,f][1,4]thiazepine
Quetiapine Ethyl Ether

QTP403 1011758-06-7
2-[2-(4-dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-1-ethyl ethanol
Rabeprazole
Rabeprazole Sodium
RBP100 117976-90-6
Sodium 2-[[4-(3-methoxypropoxy)-3-methyl-pyridin-2-yl]methylsulfinyl]benzoimidazole
Rabeprazole EP Impurity A
RBP201 117976-47-3
Rabeprazole USP Related Compound D ; Rabeprazole Sulfone ;
Rabeprazole EP Impurity B
RBP202 117977-21-6
Rabeprazole USP Related Compound E ; Rabeprazole Sulfide ;
Rabeprazole EP Impurity D
RBP204 924663-38-7
Rabeprazole USP Related Compound B , Rabeprazole N-Oxide
Rabeprazole EP Impurity F
RBP206 583-39-1
Rabeprazole USP Related Compound C ; Lansoprazole EP Impurity E
Rabeprazole EP Impurity I
RBP209 924663-37-6
Rabeprazole Sulfone N-Oxide
Rabeprazole EP Impurity K
RBP211 615-16-7
Lansoprazole EP Impurity D ; 2-Hydroxybenzimidazole
Rabeprazole Sulfide N-Oxide
RBP401 924663-40-1
Rabeprazole Sulfide N-Oxide ;
Page 63
Rabeprazole 2-Chloromethyl Impurity
RBP402 153259-31-5
2-Chloromethyl-3-methyl-4-(3-methoxypropoxy)pyridine hydrochloride
Raloxifene
Raloxifene EP Impurity A
RLX201 1159977-58-8
7-[4-(2-Piperidinyl)ethoxy]benzoyl Raloxifene
Raloxifene EP Impurity B
RLX202 1391054-73-1
Raloxifene Isomer; 3-Des[4-(2-Piperidinyl)ethoxy]benzoyl-7-[4-(2-Piperidinyl)ethoxy]benzoyl Raloxifene;
Raloxifene EP Impurity C
RLX203 195454-31-0
[6-Hydroxy-2-(4-hydroxyphenyl)-1-benzothien-3-yl][4-[2-(1- oxidopiperidin-1-yl)ethoxy]phenyl]methanone
Raloxifene EP Impurity D
RLX204 177744-96-6
(6-Hydroxy-2-(4-hydroxyphenyl)benzo[b]thiophen-3-yl)(4-hydroxy phenyl) methanone
Ranolazine
Ranolazine
RNL100 95635-55-5
N-(2,6-Dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-1-piperazineacetamide
Ranolazine Related Compound A
RNL301 2210-74-4
2-[(2-Methoxyphenoxy)methyl]oxirane
Ranolazine Related Compound B
RNL302 755711-09-2 Ranolazine Desmethoxy Impurity ; N-(2,6-dimethylphenyl)-2-(4-(2-hydroxy-3-phenoxypropyl)piperazin-1-
yl)acetamide
Ranolazine Related Compound C
RNL303 5294-61-1
1-[(2,6-dimethylphenyl)aminocarbonylmethyl]piperazine
Ranolazine Related Compound D
RNL304 380204-72-8
N,N’-bis(2,6-Dimethylphenyl)-1,4-piperazinediacetamide
Ranolazine Related Compound 2
RNL401 93-14-1
Guaifenesin ; 3-(2-methoxyphenoxy)propane-1,2-diol
Ranolazine Related Compound 4
RNL402 2210-74-4
1-(2-methoxyphenoxy)-2,3- epoxy propane
Ranolazine impurity C
RNL403 162712-35-8
1-(2-methoxyphenoxy)-3-(piperazin-1-yl)propan-2-ol
Ranolazine impurity 1
RNL404 25772-81-0
1-chloro-3-(2-methoxyphenoxy)propan-2-ol
Ranolazine Dimer Impurity
RNL405 333749-57-8
α,α’-Bis[(2-Methoxyphenoxy)methyl]-1,4-piperazinediethanol
Ranolazine N-Oxide
Ranolazine N-Oxide;
RNL406 NA
1-(2-((2,6-dimethylphenyl)amino)-2-oxoethyl)-4-(2-hydroxy-3-(2- methoxyphenoxy)propyl)piperazine 1-
oxide; Ranolazine Mono-N-oxide
P-Ranolazine
RNL407 1393717-45-7
Ranolazine impurity 2/ Dianisylglycerol

RNL408 16929-60-5 1,3-Bis(2-methoxyphenoxy)-2-propanol ,
Guaifenesin EP Impurity D
Ranolazine impurity 3
RNL409 29183-14-0
Acetamide, N-(2,6-dimethylphenyl)-2-hydroxy, N-(2,6-Dimethylphenyl)-2-hydroxyacetamide
1,3-bis(2-methoxyphenoxy)propan-2-ol
RNL410 NA
1,3-bis(2-methoxyphenoxy)propan-2-ol
m-Ranolazine
RNL411 1393717-46-8
Page 64
Ranolazine Bis(N-Oxide)
RNL412 1246816-00-1 1-(2-((2,6-dimethylphenyl)amino)-2-oxoethyl)-4-(2-hydroxy-3-(2-methoxyphenoxy)propyl)piperazine 1,4-
dioxide
Rivaroxaban
Rivaroxaban
RVX100 366789-02-8 5-Chloro-N-[[(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-5-oxazolidinyl]
methyl]-2-thiophenecarboxamide
Rivaroxaban R-Isomer/ Rivaroxaban EP Impurity A

RVX401 865479-71-6 ent-Rivaroxaban ; 5-chloro-N-[[(5R)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-
yl]methyl]thiophene-2-carboxamide
RIVAROXABAN RELATED COMPOUND H

RVX308 1770812-37-7
((S)-4,5-Dichloro-N-({2-oxo-3-[4-(3-oxomorpholino)phenyl]oxazolidin-5-yl}methyl)thiophene-2-carboxamide)
Rivaroxaban Impurity 1
RVX501 446292-04-2
4-(4-Nitrophenyl)morpholin-3-one
RVX502 438056-69-0
4-(4-Aminophenyl)morpholin-3-one
Rivaroxaban impurity 24
RVX503 161596-47-0
(S)-2-(Oxiran-2-ylmethyl)isoindoline-1,3-dione
RVX504 550-44-7
2-Methylisoindoline-1,3-dione
RVX505 181140-34-1
(R)-2-(Oxiran-2-ylmethyl)isoindoline-1,3-dione
RVX506 24065-33-6
5-Chlorothiophene-2-carboxylic acid
RVX507 96-43-5 2-Chlorothiophene

RVX508 106-89-8
Epichlorohydrin
RVX509 85-41-6
Phthalimide
RVX510 67843-74-7
(S)-Epichlorohydrin
RVX511 19532-98-0
N1,N2-Dimethylphthalamide
Rizatriptan
RZT100 145202-66-0 Rizatriptan Benzoate
Rizatriptan EP Impurity A
RZT501 887001-08-3/ 2-(5-((1H-1,2,4-triazol-1-yl)methyl)-2-((3-(2-(dimethylamino)ethyl)-1H-indol-5-yl)methyl)-1H-indol-3-yl)-N,N-
dimethylethan-1-amine
Rizatriptan Impurity 1
RZT202 119192-10-8
4-(1H-1,2,4-Triazol-1-ylmethyl)benzenamine
Rosuvastatin Calcium
RSV100 147098-20-2 (3R,5S,6E)-7-{4-(4-Fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-3,5-
dihydroxyhept-6-enoic acid calcium salt
Rosuvastatin EP Impurity D
RSV204 503610-43-3 N-[4-(4-Fluorophenyl)-6-(1-methylethyl)-5-[(1E)-2-[(2S,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
yl]ethenyl]-2-pyrimidinyl]-N-methyl-methanesulfonamide
RSV211 1422954-12-8 ROSUVASTATIN IMPURITY-K
Page 65
REV213 847849-66-5 ROSUVASTATIN IMPURITY-M
Roxithromycin
RXT100 80214-83-1 Roxithromycin
Rufinamide
Rufinamide
RFN100 106308-44-5
1-[(2,6-Difluorophenyl)methyl]-1H-1,2,3-triazole-4-carboxamide
Rufinamide acid impurity
RFN401 166196-11-8
1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxylic acid
Rufinamide Ethylester
RFN402 869501-51-9
Ethyl 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxylate
Rufinamide-5-Carboxamide
RFN403 1622904-99-7
3-(2,6-Difluorobenzyl)-3H-1,2,3-triazole-5-carboxamide
Rufinamide 3-chloro impurity
RFN404
1-(3-chloro-2,6-difluoro-benzyl)-1H-[1,2,3]triazole-4-carboxylic acid amide
Rufinamide Related Compound A

RFN301 106308-41-2
6-Desfluoro Rufinamide, 1-[(2-Fluorophenyl)methyl]-1H-1,2,3-triazole-4-carboxamide
Rufinamide Related Compound B

RFN302 217448-86-7
Rufinamide Methyl Ester Analog ; 1-(2,6-Difluorobenzyl)-1H-1,2,3-triazole-4-carboxylic acid methyl ester
Salicylic Acid
SLC100 Salicylic Acid
SLC401 99-96-7 Salicylic acid impurity A
SLC402 636-46-4 Salicylic acid impurity B
SLC403 108-95-2 Salicylic acid impurity C
Sitagliptin
STG100 486459-71-6 Sitagliptin
Sitagliptin EP Impurity A
STG201 823817-55-6 (S)-SitagliptinIsomer ; (S)-4-Oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-
(2,4,5-trifluorophenyl)butan-2-amine ;
Sitagliptin EP Impurity D
STG204 1253056-18-6 Sitagliptin Phenylcrotonyl Analog;(E)-1-(3-(Trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-
yl)-4-(2,4,5-trifluorophenyl)but-2-en-1-one
936630-57-8/ Sitagliptin FP Impurity E
STG401
1204818-19-8 (Hcl salt) (3R)-3-amino-4-(2,4,5-trifluorophenyl)butanoic acid
Sitagliptin Triazole Hydrochloride

STG402 762240-92-6 Sitagliptin Impurity 20 HCl; 3-(Trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine
hydrochloride
Sitagliptin Ketoamide Impurity

STG403 64667-65-4 Sitagliptin dioxo impurity; (2Z)-4-Oxo-4-[3-(trifluoroMethyl)-5,6-dihydro-[1,2,4] triazolo[4,3-a]pyrazine-7(8H)-
yl]-1-(2,4,5-trifluorophenyl)butan-2-one
Page 66
Sitagliptin N-Acetyl Impurity
Sitagliptin impurity D; N-Acetyl Sitagliptin ;
STG404 1379666-94-0
7-[(3R)-3-[(N-Acetyl)amino]-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-
triazolo[4,3-a]pyrazine
(S)-Sitagliptin N-Boc-Acid Impurity
STG405 922178-94-7
(S)-3-((tert-butoxycarbonyl)amino)-4-(2,4,5-trifluorophenyl)butanoic acid
(R)-Sitagliptin N-Boc-Methyl-Ester Impurity

STG406 881995-73-9
methyl (R)-3-((tert-butoxycarbonyl)amino)-4-(2,4,5-trifluorophenyl)butanoate
(R)-Sitagliptin Methyl-Ester
STG407 881995-69-3
Impurity methyl (R)-3-amino-4-(2,4,5-trifluorophenyl)butanoate
Sitagliptin Impurity 19
STG408 486460-00-8
(R)-3-((tert-butoxycarbonyl)amino)-4-(2,4,5-trifluorophenyl)butanoic acid
STG409 486460-23-5 tert-butyl (R)-(4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo
[4,3-a]pyrazin-7(8H)-yl)-1-(2,4,5-trifluorophenyl)butan-2-yl)carbamate
STG410 NA (R)-N-(4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo
[4,3-a]pyrazin-7(8H)-yl)-1-(2,4,5-trifluorophenyl)butan-2-yl)formamide
STG411 1481965-39-2
7-Nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine
4-Methyl L-Aspartate Hydrochloride

STG501 16856-13-6
4-Methyl L-Aspartate Hydrochloride
D-Aspartic Acid 4-Methyl Ester Hydrochloride
STG502 22728-89-8
D-Aspartic Acid 4-Methyl Ester Hydrochloride
STG503 209995-38-0 2,4,5-Trifluorophenylacetic Acid

MELDRUM'S ACID
STG504 2033-24-1
2,2-Dimethyl-1,3-dioxane-4,6-dione
Sulfamethoxazole
SLF100 723-46-6 Sulfamethoxazole
Sulfamethoxazole EP Impurity A
SLF201
N-Acetyl Sulfamethoxazole, N-(4-(N-(5-Methylfuran-3-yl)sulfamoyl)phenyl)acetamide
Sulfamethoxazole EP Impurity C
SLF203 1072-67-9
Sulfamethoxazole USP Related Compound C, 5-Methylisoxazol-3-amine
Sulfamethoxazole EP Impurity F
SLF206 17103-52-5
Isosulfamethoxazole, 4-Amino-N-(3-methylisoxazol-5-yl)benzenesulfonamide
Sulfaquinoxaline
SLP100 59-40-5 Sulfaquinoxaline
Suvorexant
Diazepane Impurity
SVR401 1266975-27-2(BASE) (R)-5-chloro-2-(5-methyl-1,4-diazepan-1-yl)benzo[d]oxazole TFA salt, 5-chloro-2-[(5R)-5-methyl-1,4-diazepan-
1-yl]-1,3-benzoxazole Trifluoroacetic acid salt.
Page 67
Des-Chloro impurity
SVR402 NA (R)-(4-(benzo[d]oxazol-2yl)-7-methyl-1,4-diazepan-1-yl)(5-methyl- 2-(2H-1,2,3-triazol-2-
yl)phenyl)methanone.
Regio-isomer impurity
SVR403 NA (R)-(4-(5-chlorobenzo[d]oxazol-2-yl)-5-methyl-1,4-diazepan-1-yl)(5-methyl-2-(2H-1,2,3-trizol-2-
yl)phenyl)methanone
MTM Impurity
SVR404 NA
(R)-(7-methyl-1,4-diazepan-1-yl)(5-methyl-2-(2H-1,2,3-trizol-2-yl)phenyl)methanone
DCO Impurity
SVR405 3621-81-6
2,5-Dichlorobenzooxazole
Tadalafil
TDL100 171596-29-5 (6R,12aR)-6-(1,3-Benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methylpyrazino [1’,2’:1,6]pyrido[3,4-b]indole-
1,4-dione; Cialis;
Tamsulosin
Tamsulosin
TMS100 2-(4-{[4-Methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3
-benzodiazol-1-yl] methyl}phenyl)benzoic acid
Telmisartan
144701-48-4 Telmisartan
TLM100 2-(4-{[4-Methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3
-benzodiazol-1-yl] methyl}phenyl)benzoic acid
Telmisartan EP Impurity A
TLM201 152628-02-9
Telmisartan USP Related Compound A
Telmisartan EP Impurity B
TLM202 1026353-20-7
Telmisartan USP Related Compound B ; Telmisartan Isomer
Telmisartan EP Impurity C
TLM203 144702-26-1
Telmisartan t-Butyl Ester
Telmisartan EP Impurity E
TLM205 884330-12-5
Telmisartan Diacid
Telmisartan EP Impurity F
TLM206 915124-86-6
Telmisartan Amide
Telmisartan EP Impurity G
TLM207 144702-27-2
Telmisartan Cyano Analog ; 2-Descarboxy-2-Cyano Telmisartan
Telmisartan EP Impurity H
TML208 114772-40-6
t-Butyl 4'-bromomethyl biphenyl-2-carboxylate
Telmisartan Methyl Ester
TLM401 528560-93-2 2-(4-{[4-Methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3-benzodiazol-1-
yl]methyl}phenyl)benzoic acid methyl ester
Telmisartan Ethyl Ester
TLM402 528560-94-3 2-(4-{[4-Methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl
-1H-1,3-benzodiazol-1-yl] methyl}phenyl)benzoic acid ethyl ester
Telmisartan Bromo Nitrile Impurity

TLM403 114772-54-2
4'-(Bromomethyl)-[1,1'-biphenyl]-2-carbonitrile ; 2-(4-Bromomethylphenyl) benzonitrile
Telmisartan Impurity 1
TLM404 152628-03-0
Telmisartan Benzimidazole Acid
Page 68
Temazepam
Temazepam EP impuirty A ;TMZ Benzophenone
TMZ201 1022-13-5
5-chloro-2-(methylamino)phenyl]phenylmethanone
Temazepam EP impuirty C ;TMZ Acetoxy
TMZ203 1824-74-4 Oxazepam Related Compound B;(3RS)-7-chloro-1-methyl-2-oxo-5-phenyl-2,3-dihydro-1H-1,4-benzodiazepin-
3-yl acetate
Temazepam Impurity E;TMZ N OXIDE

TMZ205 2888-64-4
7-chloro-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one 4-oxide
Temazepam EP Impurity F;TMZ Dion

TMZ206 3294-96-0
(5RS)-7-chloro-1-methyl-5-phenyl-4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione
TMZ Impurity G
TMZ207 93329-92-1
(5RS)-7-chloro-1,4-dimethyl-5-phenyl-4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione.
2-Chloroacetamido-5-chlorobenzophenone
TMZ401 6021-21-2 2-Chloroacetamido-5-chlorobenzophenone; 5-Chloro-2-(chloroacetamido)benzophenone; 5-Chloro-2-
chloracetylaminobenzophenone; N-(2-Benzoyl-4-chlorophenyl)-2-chloroacetamide
Teneligliptin
Teneligliptin HBr
TNL100 906093-29-6 [(2S,4S)-4-[4-(3-Methyl-1-phenyl-1H-pyrazol-5-yl)-1-piperazinyl]-2-pyrrolidinyl]-3-thiazolidinylmethanone
HBr
Tenegliptin impurity A
TNL401 401566-79-8
1-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazine
Tenteligliptin impurity B
TNL402 401566-80-1 tert-butyl (2S,4S)-4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)-2-(thiazolidine-3-
carbonyl)pyrrolidine-1-carboxylate
Tenteligliptin impurity C
TNL403 NA
(2S)-tert-butyl4-hydroxy-2-(thiazolidine-3-carbonyl)pyrrolidine-1-carboxylate
Tenteligliptin impurity 1
TNL404 401564-36-1
(2S)-4-Oxo-2-(3-thiazolidinylcarbonyl)-1-pyrrolidinecarboxylic Acid 1,1-Dimethylethyl Ester
Teneligliptin (2R,4R)-Isomer
TNL405 1404559-17-6 (Free Base) {(2R4R)-4-[4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazine-l-yl]pyrrolidine-2-yl}( 1.3-thiazolidine-3-
yl)methanonehemipentahydrobromide hydrate
Teneligliptin BOC acid Impurity

TNL406 1821705-03-6 (2S,4S)-1-(tert-butoxycarbonyl)-4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidine-2-
carboxylic acid
(2S,4R)-Teneligliptin Hydrobromide
TNL407 1404559-15-4 (2S, 4R)-4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl) piperazin-1-yl) pyrrolidin-2-yl) (thiazolidin-3-yl) methanone
Hydrobromide.
(2R,4S)-Teneligliptin Hydrobromide
TNL408 NA (2R, 4S)-4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl) piperazin-1-yl) pyrrolidin-2-yl) (thiazolidin-3-yl) methanone
Hydrobromide.
TNL501 147266-92-0
(2R,4S)-1-(tert-butoxycarbonyl)-4-hydroxypyrrolidine-2-carboxylic acid
Page 69
TNL502 NA
3-[(2R,4S)-1-tert-Butoxycarbonyl-4-hydroxy-2-pyrrolidinylcarbonyl]-1,3-thiazolidine
TNL503 NA
(2R)-4-Oxo-2-(3-thiazolidinylcarbonyl)-1-pyrrolidinecarboxylic Acid 1,1-Dimethylethyl Ester
Teriflunomide
Teriflunomide
TRF100 163451-81-8
(2Z)-2-Cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2-enamide
Teriflunomide Impurity 1
TRF401/LFN205 208401-20-1
TRF402 1011244-72-6 4-amino-N-(4-(trifluoromethyl)phenyl)benzamide
TRF403 2366-92-9
1-ethoxy-4-(trifluoromethyl)benzene
TRF404 349-97-3
N-(4-(trifluoromethyl)phenyl)acetamide
Teriflunomide EP Impurity B
TRF202 24522-30-3
2-cyano-N-(4-(trifluoromethyl)phenyl)acetamide
TRF405/LFN100 75706-12-6
Leflunomide ; 5-Methyl-N-[4-(trifluoromethyl)phenyl]isoxazole-4-carboxamide
Teriflunomide ortho isomer

TRF406 220512-86-7
Teriflunomide ortho isomer
Teriflunomide Meta isomer

TRF407 63927-52-6
Teriflunomide Meta isomer
Tetracycline
Tetracycline
TRC100 60-54-8 (4S,6S,12aS)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-
3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxonaphthacene-2-carboxamide
TRC101 64-75-5 Tetracycline hydrochloride
Anhydro tetracycline impurity

TRC401 NA (4S,4aS,12aS)-4-(Dimethylamino)-1,4,4a,5,12,12a-Hexahydro-
3,10,11,12a-Tetrahydroxy-6-Methyl-1,12-Dioxotetracene-2-Carboxamide
Thiamazole
Thiamazole
THM100
60-56-0 1-Methyl-3H-imidazole-2-thione
Thiamazole EP Impurity B
THM202 616-47-7
1-Methyl-1H-imidazole; N-Methylimidazole
Thiamine monophosphate chloride di hydrate
THN100 273724-21-3 2-[3-[(4-Amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazol-3-ium-5-yl]ethyl dihydrogen Phosphate
Chloride Dihydrate
Tinidazole
Tinidazole
TND100 19387-91-8
1-(2-(ethylsulfonyl)ethyl)-2-methyl-5-nitro-1H-imidazole
Tinidazole EP Impurity A
TND201 696-23-1
Tinidazole USP Related Compound A ; 2-Methyl-5-nitroimidazole
Page 70
Tirofiban
TRB100 144494-65-5
(S)-2-(butylsulfonamido)-3-(4-(4-(piperidin-4-yl)butoxy)phenyl)propanoic acid
Tirofiban Impurity A
TRB401 149490-60-8
L-N-Butylsulfonyl-p-hydroxyphenylalanine,
149463-65-0 TIROFIBAN IMPURITY B
TRB402
4-(4-Chlorobutyl)pyridine hydrochloride
Tolterodine
TLR100 Tolterodine
Tolterodine Lactone Impurity Racemate

TLR402 40546-94-9
6-Methyl-4-phenyl-3,4-dihydro-1-benzopyran-2-one ; 6-methyl-4-phenylchroman-2-one
Tolterodine EP Impurity A
TLR201 124937-73-1
3-(2-methoxy-5-methylphenyl)-3-phenylpropan-1-ol; Tolterodine Impurity A
Tolterodine EP Impurity C
TLR 203 124935-88-2
[3-(2-methoxy-5-methyl-phenyl)-3-phenyl-propyl]-diisopropyl amine
Tolterodine EP Impurity D
TLR204 1391053-65-8 N-isopropyl-3-(2-methoxy-5-methylphenyl)-3-phenylpropan-1-amine hydrochloride; Tolterodine EP Impurity
D
Tolterodine EP Impurity E/ Tolterodine monoisopropyl analog
TLR205 480432-14-2
4-Methyl-2-[(1RS)-3-[(1-methylethyl)amino]-1-phenylpropyl]pheno
Tolterodine Propanol Impurity
TLR403 851789-43-0
4-Methyl-2-[(1RS)-3-[(1-methylethyl)amino]-1-phenylpropyl]pheno
Tolterodine Lactol Impurity
TLR404 209747-04-6
3,4-Dihydro-6-methyl-4-phenyl-2H-1-benzopyran-2-ol ; 6-methyl-4-phenylchroman-2-ol
TRM100 36282-47-0 Tramadol

Tramadol EP Impurity A
TRM201 152538-36-8/36282-47-0
Tramadol Related Compound A
Tramadol EP Impurity B
TRM202 66170-32-9 1-(3'-methoxy-3,4,5,6-tetrahydro-[1,1'-biphenyl]-2-yl)-N,N-dimethyl
methanamine hydrochloride
Tramadol EP Impurity C
TRM203 66170-31-8/192384-41-1(free base)
1-(3'-methoxy-2,3,4,5-tetrahydro-[1,1'-biphenyl]-2-yl)-N,N-dimethyl
methanamine hydrochloride
148218-19-3/ 80456-81-1/ Tramadol EP Impurity D
TRM204
73986-53-5 3-(2-((dimethylamino)methyl)-1-hydroxycyclohexyl)phenol hydrochloride
Tramadol EP Impurity E
TRM205 42036-65-7
Tramadol Related Compound B ; 2-((dimethylamino)methyl)cyclohexan-1-one hydrochloride
Tramadol N-Oxide
TRM401 147441-56-3 1-((1S,2S)-2-hydroxy-2-(3-methoxyphenyl)cyclohexyl)-
N,N-dimethylmethanamine oxide
Tramadol EP Impurity A ( Free Base)
TRM402 NA
(±)-trans-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol
Trelagliptin Impurity I /Trelagliptin impuirty A/ succinate salt

TRG401 1812193-01-3 (R)-4-Fluoro-2-((3-methyl-2,4-dioxo-6-(piperidin-3-ylamino)-3,4-dihydropyrimidin-1(2H)-
yl)methyl)benzonitrile
Page 71
Trelagliptin Impurity II / Trelagliptin impuirty B
TRG402 2087874-92-6 (R)-4-((1-(3-(2-Cyano-5-fluorobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)piperidin-3-
yl)amino)-4-oxobutanoic Acid
Trelagliptin Impurity III / Trelagliptin impuirty C

TRG403 865759-24-6
2-((6-Chloro-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzonitrile
Trelagliptin Impurity S-Isomer /Trelagliptin impuirty D

TRG404 2206135-35-3 (S)-2-((6-(3-Aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-
fluorobenzonitrile
TRG405 1938080-43-3 Trelagliptin impuirty E
TRL100 68786-66-3 Triclabendazole
TRP100 1508-75-4 Tropicamide
Tropicamide EP Impurity A
TRP201 33403-97-3
Tropicamide related compound A, N-(pyridin-4-ylmethyl)ethanamine
Tropicamide EP Impurity B
TRP202 57322-50-6 Tropicamide related compound B
Tropicamide EP Impurity C
TRP203 552-63-6
Tropicamide related compound C
Tropicamide EP Impurity D
TRP204 103-82-2
Tropicamide related compound D, phenylacetic acid
Ursodiol
URS100 Ursodiol
URS401 481-29-8 Epiandrosteron
Valganciclovir
Valganciclovir Hydrochloride
VLG100 175865-59-5
L-Valine 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxy propyl ester hydrochloride
Valaciclovir EP Impurity A
VLG201 73-40-5 Valganciclovir related compound B
Valganciclovir related compound B, A ciclovir EP Impurity B ; Guanine
VLG401 3056-33-5 Diacetylguanine
Valsartan
Valsartan
VLS100 137862-53-4
(S)-N-[p-(o-1H-Tetrazol-5-ylphenyl)benzyl]-N-valeryl-L-valine
Valsartan EP Impurity A
VLS201 137862-87-4 Valsartan USP Related Compound A ; Valsartan R-Isomer ; (R)-Valsartan,
(R-N-Valeryl-N-([2'-(1H-tetrazole-5-yl)biphen-4-yl]methyl)valine
Valsartan EP Impurity B
VLS202 137863-20-8
Valsartan USP Related Compound C ; Valsartan Benzyl Ester
Page 72
Valsartan EP Impurity C
VLS203 952652-79-8
Valsartan related compound B ; Valsartan N-Butyryl Analog
N-Nitrosodimethylamine
VLS401 62-75-9
N-Methyl-N-nitrosomethanamine; DMN; DMNA;
N- nitrosodiethylamine (NDEA).
VLS402 55-18-5
N-Ethyl-N-nitrosoethanamine; DEN; DENA; Diethylnitrosamide
Nitroso-N-methyl-4-aminobutyric acid (NMBA)
VLS403 61445-55-4
4-(Methylnitrosoamino)butanoic Acid; N-Methyl-N-(3-carboxypropyl)nitrosamine
Valsaratan Azido Nitrile Impurity
VLS404 133690-91-2
4'-(Azidomethyl)-[1,1'-biphenyl]-2-carbonitrile
Valsaratan Azido Tetrazole Impuity
VLS405 152708-24-2
5-[4'-(Azidomethyl)[1,1'-biphenyl]-2-yl]-2H-tetrazole
Venlafaxine
Venlafaxine HCl
VNL100 99300-78-4
1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol hydrochloride
Venlafaxine EP Impurity A
VNL201
775-33-7 2-(4-Methoxyphenyl)-N,N-dimethylethanamine
323176-93-8/2174001-92-2 Venlafaxine EP Impurity B
VNL202
Hcl Venlafaxine Ester Impurity, Ethyl (2RS)-3-(dimethylamino)-2-(4-methoxyphenyl)propanoate
Venlafaxine EP Impurity C
VNL203 130198-05-9
N,N-Didesmethyl Venlafaxine Hydrochloride
Venlafaxine EP Impurity D
VNL204 149289-30-5
Venlafaxine USP Related Compound A
Venlafaxine EP Impurity E
VNL205 93413-70-8/93413-56-0
(5RS)-5-(4-methoxyphenyl)-3-methyl-1-oxa-3-azaspiro[5.5]undecane
Venlafaxine EP Impurity F
VNL206 93413-79-7 (HCl)/ 93413-57-1 (2RS)-2-(Cyclohex-1-enyl)-2-(4-methoxyphenyl)-N,N-dimethylethanamine hydrochloride ; 2-Cyclohexenyl-2-
(4-methoxyphenyl)-N,N -dimethylethanamine hydrochloride
Venlafaxine EP Impurity G
VNL207 1076199-92-2
Deshydroxy Venlafaxine , 1-[2-Dimethylamino-1-(4-methoxyphenyl) ethyl] cyclohexane
Venlafaxine EP Impurity H
VNL208 1329795-88-1
1-[(1RS)-1-(4-methoxyphenyl)-2-[[2-(4-methoxyphenyl)ethyl]amino]ethyl]cyclohexanol
Venlafaxine O-Desmethyl Impurity

VNL401 93413-62-8
4-[2-(Dimethylamino)-1-(1-hydroxycyclohexyl)ethyl]phenol ; Desvenlafaxine
VNL402 1094598-37-4 Venlafaxine N-Oxide
Vigabatrin Related Compound B

VGB302 1379403-11-8
(2E)-2-(2-Aminoethyl)but-2-enoic Acid Hydrochloride
Vildagliptin
Vildagliptin
VLD100 274901-16-5
(2S)-1-[2-[(3-Hydroxytricyclo[3.3.1.13,7]dec-1-yl)amino]acetyl]-2-pyrrolidinecarbonitrile
Vildagliptin Impuirty A
VLD401 1789703-37-2
Vildagliptin CyclicAmidine;2-(3-Hydroxyadamantan-1-yl)-1-iminohexahydropyrrolo[1,2-a]pyrazin-4(1H)-one
Page 73
Vildagliptin Impurity B
VLD402 565453-39-6
Vildagliptin amide impurity;1-[(3-Hydroxyadamant-1-ylamino)-acetyl]-(2S)-prolinamide
Vildagliptin Impurity C
VLD403 1789703-36-1
Vildagliptin Diketo Impurity;2-(3-Hydroxyadamantan-1-yl)hexahydropyrrolo[1,2-a]pyrazine-1,4-dione
Vildagliptin Impurity D
VLD404 1036959-23-5 (2S,2'S)-1,1'-(2,2'-(((1r,3R,5R,7S)-3-hydroxyadamantan-1-yl)azanediyl)
bis(acetyl))bis(pyrrolidine-2-carbonitrile);Vildagliptin Dimer Impurity
(R)-Vildagliptin
VLD405 1036959-27-9
(R)-1-(((1r,3S,5R,7S)-3-hydroxyadamantan-1-yl)glycyl)pyrrolidine-2-carbonitrile
Vildagliptin Chloroacetyl Amide (S)-Isomer
VLD406 214398-99-9
(S)-1-(2-chloroacetyl)pyrrolidine-2-carboxamide
Vildagliptin Chloroacetyl Amide (R)-Isomer
VLD407 1211679-98-9
(R)-1-(2-Chloroacetyl)pyrrolidine-2-carboxamide
Vildagliptin Carboxylic Acid Impurity

VLD409 565453-40-9 (2S)-1-[2-[(3-Hydroxytricyclo[3.3.1.13,7]dec-1-yl)amino]acetyl]-2-pyrrolidine
carboxylic acid
Gly-Pro-CN TFA SALT

VLD410 NA
(2S)-1-(AMINOACETYL) PYRROLIDINE -2-CARBONITRILE
Cyclo(-Gly-Pro)
VLD411 3705-27-9
(S)-Hexahydro-pyrrolo[1,2-a]pyrazine-1,4-dione
Vildagliptin Chloroacetyl Nitrile (R)-Isomer
VLD412 565452-98-4
Vildagliptin Chloroacetyl Nitrile (R)-Isomer
(S)-1-(2-Hydroxyacetyl)pyrrolidine-2-carboxamide
VLD413 96166-39-1
(S)-1-(2-Hydroxyacetyl)pyrrolidine-2-carboxamide
Nitroso Vildagliptin
VLD414 NA
N-(2-((S)-2-Cyanopyrrolidin-1-yl)-2-oxoethyl)-N-((1r,3R,5R,7S)-3-hydroxyadamantan-1-yl)nitrous amide
Vildagliptin Chloroacetyl Nitrile (S)-Isomer

VLD501 207557-35-5
(2S)-1-(Chloroacetyl)-2-Pyrrolidinecarbonitrile ; Vildagliptin Impurity 14
Diazabicycloundecene impurity ,
VLD502 6674-22-2
3,4,6,7,8,9,10-Octahydropyrimido[1,2-a]azepine
1-Adamantanol
VLD503 768-95-6
2,3,4,6,7,8,9,10-Octahydropyrimido[1,2-a]azepine
Vildagliptin Amino Alcohol Impurity
VLD504 702-82-9
1-Amino-3-adamantanol ; Vildagliptin Impurity 15
Vortioxetine
Vortioxetine
VRT100 508233-74-7
1-[2-[(2,4-Dimethylphenyl)thio]phenyl]piperazine
Vortioxetine Sulfoxide
VRT401 1429908-35-9
Vortioxetine Sulfoxide
VORTIOXETINE SULFOXIDE HBr
VRT402 NA
VORTIOXETINE SULFOXIDE Hydrobromide
Vortioxetine Impurity 31
VRT403 13616-82-5
2,4-Xylenethiol; 2,4-Dimethylbenzenethiol; 2,4-Dimethylthiopheno
Warfarin
Warfarin
WRF100 81-81-2
2-Oxo-3-[(1RS)-3-oxo-1-phenylbutyl]-2H-1-benzopyran-4-ol
Page 74
Zolpidem
Zolpidem Tartrate
ZLP100 82626-48-0
N,N,6-Trimethyl-2-(4-methylphenyl)imidazo[1,2-a]pyridine-3-acetamide
Zolpidem Tartrate EP Impurity A
ZLP201 1346600-85-8
Zolpidem USP Related Compound A
Zolpidem Tartrate EP Impurity B
ZLP202 NA 2-[2-(3-bromo-4-methylphenyl)-6-methylimidazo[1,2-a]pyridin-3-yl]
-N,N-dimethylacetamide
N,N-Dimethylprop-2-ynamide
ZLP401 2682-34-0
N,N-Dimethylprop-2-ynamide
Zonisamide
Zonisamide
ZNS100 68291-97-4
1,2-Benzisoxazole-3-methanesulfonamide
Zonisamide Related Compound A
ZNS301 73101-64-1
(1,2-benzisoxazole-3-methanesulfonic acid sodium salt
Zonisamide Related Compound C

ZNS303 1217201-89-2
N,N-Dimethyl Formimidamide ; (E)-N'-((benzo[d]isoxazol-3-ylmethyl)sulfonyl)-N,N-dimethylformimidamide
N-Methyl Zonisamide
ZNS401 68292-02-4
N-Methyl-1,2-benzisoxazole-3-methanesulfonamide
1,2-Benzisoxazol-3-ylacetic Acid
ZNS402 4865-84-3
1,2-Benzisoxazol-3-ylacetic Acid
Page 75
Certificate of Analysis
Name: Ozanimod (R)-enantiomer Impurity
Synonyms: (R)-4-(3-(1-((2-Hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-
isopropoxybenzonitrile
Structure:
Product Information :
Product code: OZN403 Batch Number : A3-523
Molecular Formula : C23H24N4O3: HCl Molecular Weight:404.5 : 36.45
Analysis Date : Aug-2022 Retest Date : Aug-2026
Long term Storage Condition: Store at 2°C to 8°C
Shipping Condition: This product is stable to be shipped at room temperature
Analytical Information :
Sr.No Test Results
1 Appearance Off-White Solid
2 Identification
1) H1NMR Conforms to the structure
2) C13NMR Conforms to the structure
3) IR Conforms to the structure
4) Mass Conforms to the structure
3 Purity (By HPLC) 99.49%
4 TGA (Weight Loss: 30°C to 105°C) 1.23%
5 ROI (800°C) 6.24%
6 DEFINED POTENCY 92.05%
7 UV 231nm
Prepared By: Reviewed By:
Dr. Amit Nagare Dr. Amol Taywade

Date: 01.06.2023 Date: 01.06.2023
Note: This product is not for human or animal consumption
02-Aug-22 4:19:46 PM Page 1 / 1
Analysis Report
<Sample Information>
Sample Name : Diluent
Sample ID : Blank
Data Filename : QC14-220802-001.lcd
Method Filename : 0.1%OPA METHOD.lcm
Batch Filename : 02.08.2022.lcb
Vial # : 1-1 Sample Type : Unknown
Injection Volume : 10 uL
Date Acquired : 02-Aug-22 2:51:36 PM Acquired by : B Swapna
Date Processed : 02-Aug-22 4:06:52 PM Processed by : B Swapna
<Chromatogram>
mAU
1000
PDA Multi 1 254nm,4nm
750
500
250
0 5 10 15 20
min
<Peak Table>
PDA Ch1 254nm
Peak# Ret. Time Area Conc. Area%
Total
AUG-2022 - 2-1/2-1 - QC14-220802-001.lcd

02-Aug-22 4:08:12 PM Page 1 / 1
Analysis Report
<Sample Information>
Sample Name : A3-523
Sample ID : A3-523
Data Filename : QC14-220802-003.lcd
Method Filename : 0.1%OPA METHOD.lcm
Batch Filename : 02.08.2022.lcb
Vial # : 1-33 Sample Type : Unknown
Injection Volume : 10 uL
Date Acquired : 02-Aug-22 3:42:22 PM Acquired by : B Swapna
Date Processed : 02-Aug-22 4:07:24 PM Processed by : B Swapna
<Chromatogram>
mAU
PDA Multi 1 254nm,4nm

7.387
1000
750
500
250
8.221
0 5 10 15 20
min
<Peak Table>
PDA Ch1 254nm
Peak# Ret. Time Area Height Area%
1 7.387 9988869 1045965 99.491
2 8.221 51098 5720 0.509
Total 10039967 1051685 100.000
AUG-2022 - 2-1/2-3 - QC14-220802-003.lcd

KARPSCHEM LABORATORIES PVT LTD
A3-523
1H-NMR/DMSO
01-AUG-2022
Current Data Parameters

NAME QC11220801009
9.117
8.543
8.538
8.434
8.428
8.411
8.406
8.179
8.161
7.938
7.919
7.599
7.584
7.580
7.561
5.305
5.292
5.280
5.002
4.987
4.972
4.917
3.719
3.706
3.693
3.680
3.507
3.485
3.467
3.453
3.447
3.303
3.293
3.282
3.270
3.259
3.248
3.060
3.006
2.588
2.565
2.304
2.293
2.281
1.392
1.377
EXPNO 1
PROCNO 1
F2 - Acquisition Parameters
Date_ 20220801
Time 12.40 h
INSTRUM spect
PROBHD Z108618_0828 (
PULPROG zg30
TD 65536
SOLVENT DMSO
NS 16
DS 2
SWH 8012.820 Hz
FIDRES 0.244532 Hz
AQ 4.0894465 sec
RG 195.98
DW 62.400 usec
DE 16.75 usec
TE 0 K
D1 1.00000000 sec
TD0 1
SFO1 400.0904705 MHz
NUC1 1H
P0 5.33 usec
P1 16.00 usec
PLW1 12.89900017 W
F2 - Processing parameters
SI 65536
SF 400.0880045 MHz
WDW EM
SSB 0
LB 0.30 Hz
GB 0
PC 1.00
15 14 13 12 11 10 9 8 7 6 5 4 3 2 1 0 ppm
1.97
1.00
1.04
1.06
1.07
2.12
1.03
1.09
1.08
2.11
1.39
1.39
2.26
1.13
0.89
6.10
A3-523
1H-NMR/DMSO
01-AUG-2022

NAME QC11220801009
9.117
8.543
8.538
8.434
8.428
8.411
8.406
8.179
8.161
7.938
7.919
7.599
7.584
7.580
7.561
EXPNO 1
PROCNO 1
Date_ 20220801
Time 12.40 h
INSTRUM spect
PROBHD Z108618_0828 (
PULPROG zg30
TD 65536
SOLVENT DMSO
NS 16
DS 2
SWH 8012.820 Hz
FIDRES 0.244532 Hz
AQ 4.0894465 sec
RG 195.98
DW 62.400 usec
DE 16.75 usec
TE 0 K
D1 1.00000000 sec
TD0 1
SFO1 400.0904705 MHz
NUC1 1H
P0 5.33 usec
P1 16.00 usec
PLW1 12.89900017 W
SI 65536
SF 400.0880045 MHz
WDW EM
SSB 0
LB 0.30 Hz
GB 0
PC 1.00
9.3 9.2 9.1 9.0 8.9 8.8 8.7 8.6 8.5 8.4 8.3 8.2 8.1 8.0 7.9 7.8 7.7 7.6 7.5 ppm
1.97
1.00
1.04
1.06
1.07
2.12
A3-523
1H-NMR/DMSO
01-AUG-2022

NAME QC11220801009
5.305
5.292
5.280
5.017
5.002
4.987
4.972
4.958
4.917
3.719
3.706
3.693
3.680
3.530
3.507
3.485
3.467
3.453
3.447
3.303
3.293
3.282
3.270
3.259
3.248
3.237
3.224
3.060
3.006
2.588
2.565
2.304
2.293
2.281
2.269
2.258
EXPNO 1
PROCNO 1
Date_ 20220801
Time 12.40 h
INSTRUM spect
PROBHD Z108618_0828 (
PULPROG zg30
TD 65536
SOLVENT DMSO
NS 16
DS 2
SWH 8012.820 Hz
FIDRES 0.244532 Hz
AQ 4.0894465 sec
RG 195.98
DW 62.400 usec
DE 16.75 usec
TE 0 K
D1 1.00000000 sec
TD0 1
SFO1 400.0904705 MHz
NUC1 1H
P0 5.33 usec
P1 16.00 usec
PLW1 12.89900017 W
SI 65536
SF 400.0880045 MHz
WDW EM
SSB 0
LB 0.30 Hz
GB 0
PC 1.00
5.5 5.0 4.5 4.0 3.5 3.0 2.5 ppm

1.03
1.09
1.08
2.11
1.39
1.39
2.26
1.13
0.89
A3-523
1H-NMR/DMSO
01-AUG-2022

NAME QC11220801009
1.392
1.377
EXPNO 1
PROCNO 1
Date_ 20220801
Time 12.40 h
INSTRUM spect
PROBHD Z108618_0828 (
PULPROG zg30
TD 65536
SOLVENT DMSO
NS 16
DS 2
SWH 8012.820 Hz
FIDRES 0.244532 Hz
AQ 4.0894465 sec
RG 195.98
DW 62.400 usec
DE 16.75 usec
TE 0 K
D1 1.00000000 sec
TD0 1
SFO1 400.0904705 MHz
NUC1 1H
P0 5.33 usec
P1 16.00 usec
PLW1 12.89900017 W
SI 65536
SF 400.0880045 MHz
WDW EM
SSB 0
LB 0.30 Hz
GB 0
PC 1.00
1.7 1.6 1.5 1.4 1.3 1.2 1.1 ppm

6.10
A3-523
1H-NMR/DMSO
01-AUG-2022
# ADDRESS FREQUENCY INTENSITY

[Hz] [PPM]
1 23104.5 3647.519 9.1168 0.04
2 24980.6 3418.137 8.5435 0.15
3 24998.9 3415.907 8.5379 0.16
4 25339.5 3374.258 8.4338 0.07
5 25357.9 3372.004 8.4282 0.07
6 25413.2 3365.250 8.4113 0.08
7 25431.5 3363.005 8.4057 0.07
8 26172.6 3272.403 8.1792 0.08
9 26232.6 3265.063 8.1609 0.09
10 26960.7 3176.044 7.9384 0.07
11 27022.8 3168.444 7.9194 0.08
12 28072.5 3040.108 7.5986 0.05
13 28119.3 3034.377 7.5843 0.12
14 28134.3 3032.545 7.5797 0.11
15 28195.3 3025.086 7.5611 0.13
16 35577.9 2122.445 5.3049 0.04
17 35619.3 2117.388 5.2923 0.10
18 35659.6 2112.457 5.2800 0.04
19 36518.6 2007.433 5.0175 0.02
20 36568.3 2001.359 5.0023 0.05
21 36618.0 1995.278 4.9871 0.06
22 36666.7 1989.332 4.9722 0.04
23 36714.9 1983.439 4.9575 0.02
24 36847.3 1967.250 4.9170 0.03
25 40766.9 1488.011 3.7192 0.04
26 40809.8 1482.767 3.7061 0.10
27 40852.0 1477.603 3.6932 0.10
28 40894.3 1472.437 3.6803 0.04
29 41387.4 1412.145 3.5296 0.02
30 41461.5 1403.087 3.5069 0.02
31 41534.2 1394.204 3.4847 0.03
32 41592.9 1387.018 3.4668 0.04
33 41639.1 1381.367 3.4527 0.03
34 41658.1 1379.054 3.4469 0.03
35 42128.4 1321.547 3.3031 0.03
36 42163.1 1317.309 3.2925 0.03
37 42198.6 1312.968 3.2817 0.03
38 42237.6 1308.195 3.2698 0.03
39 42274.5 1303.687 3.2585 0.02
40 42308.7 1299.500 3.2480 0.02
41 42345.1 1295.058 3.2369 0.02
42 42386.4 1289.999 3.2243 0.02
43 42925.2 1224.123 3.0596 0.03
44 43101.7 1202.551 3.0057 0.03
45 44470.1 1035.235 2.5875 0.03
46 44542.9 1026.333 2.5653 0.05
47 45397.5 921.852 2.3041 0.02
48 45433.7 917.423 2.2931 0.03
49 45473.3 912.579 2.2809 0.02
50 45510.9 907.989 2.2695 0.02
51 45548.0 903.446 2.2581 0.01
52 48380.6 557.117 1.3925 0.73
53 48429.9 551.088 1.3774 0.72
A3-523
13C-NMR/DMSO
13-MAY-2023

NAME QC11230513081
173.30
167.95
162.55
144.62
139.26
134.62
133.84
131.50
129.35
129.09
128.64
127.51
122.87
115.86
115.25
114.91
102.46
EXPNO 2
72.54
61.31
61.09
56.60
46.50
31.65
27.79
21.47
13.86
PROCNO 1
Date_ 20230513
Time 23.15 h
INSTRUM spect
PROBHD Z108618_0828 (
PULPROG zgpg30
TD 65536
SOLVENT DMSO
NS 3000
DS 4
SWH 29761.904 Hz
FIDRES 0.908261 Hz
AQ 1.1010048 sec
RG 195.98
DW 16.800 usec
DE 6.50 usec
TE 0 K
D1 2.00000000 sec
D11 0.03000000 sec
TD0 1
SFO1 100.6122678 MHz
NUC1 13C
P0 3.67 usec
P1 11.00 usec
PLW1 40.78400040 W
SFO2 400.0896004 MHz
NUC2 1H
CPDPRG[2 waltz65
PCPD2 90.00 usec
PLW2 12.89900017 W
PLW12 0.40766999 W
PLW13 0.20506001 W
SI 32768
SF 100.6022568 MHz
WDW EM
SSB 0
LB 1.00 Hz
GB 0
PC 1.40
200 180 160 140 120 100 80 60 40 20 0 ppm

A3-523
13C-NMR/DMSO
13-MAY-2023

NAME QC11230513081
173.30
167.95
162.55
144.62
139.26
134.62
133.84
131.50
129.35
129.09
128.64
127.51
122.87
115.86
115.25
114.91
102.46
EXPNO 2
PROCNO 1
Date_ 20230513
Time 23.15 h
INSTRUM spect
PROBHD Z108618_0828 (
PULPROG zgpg30
TD 65536
SOLVENT DMSO
NS 3000
DS 4
SWH 29761.904 Hz
FIDRES 0.908261 Hz
AQ 1.1010048 sec
RG 195.98
DW 16.800 usec
DE 6.50 usec
TE 0 K
D1 2.00000000 sec
D11 0.03000000 sec
TD0 1
SFO1 100.6122678 MHz
NUC1 13C
P0 3.67 usec
P1 11.00 usec
PLW1 40.78400040 W
SFO2 400.0896004 MHz
NUC2 1H
CPDPRG[2 waltz65
PCPD2 90.00 usec
PLW2 12.89900017 W
PLW12 0.40766999 W
PLW13 0.20506001 W
SI 32768
SF 100.6022568 MHz
WDW EM
SSB 0
LB 1.00 Hz
GB 0
PC 1.40
180 170 160 150 140 130 120 110 100 ppm
A3-523
13C-NMR/DMSO
13-MAY-2023

NAME QC11230513081
EXPNO 2
72.54
61.31
61.09
56.60
46.50
31.65
27.79
21.47
13.86
PROCNO 1
Date_ 20230513
Time 23.15 h
INSTRUM spect
PROBHD Z108618_0828 (
PULPROG zgpg30
TD 65536
SOLVENT DMSO
NS 3000
DS 4
SWH 29761.904 Hz
FIDRES 0.908261 Hz
AQ 1.1010048 sec
RG 195.98
DW 16.800 usec
DE 6.50 usec
TE 0 K
D1 2.00000000 sec
D11 0.03000000 sec
TD0 1
SFO1 100.6122678 MHz
NUC1 13C
P0 3.67 usec
P1 11.00 usec
PLW1 40.78400040 W
SFO2 400.0896004 MHz
NUC2 1H
CPDPRG[2 waltz65
PCPD2 90.00 usec
PLW2 12.89900017 W
PLW12 0.40766999 W
PLW13 0.20506001 W
SI 32768
SF 100.6022568 MHz
WDW EM
SSB 0
LB 1.00 Hz
GB 0
PC 1.40
90 85 80 75 70 65 60 55 50 45 40 35 30 25 20 15 10 ppm
A3-523
13C-NMR/DMSO
13-MAY-2023
# ADDRESS FREQUENCY INTENSITY

[Hz] [PPM]
1 8210.4 17434.829 173.3046 0.15
2 8803.6 16896.043 167.9489 0.14
3 9402.1 16352.397 162.5450 0.14
4 11387.4 14549.281 144.6218 0.19
5 11981.2 14009.937 139.2607 0.15
6 12495.4 13542.925 134.6185 0.16
7 12581.4 13464.810 133.8420 0.16
8 12840.8 13229.206 131.5001 0.07
9 13079.3 13012.585 129.3468 0.12
10 13107.7 12986.820 129.0907 0.11
11 13157.7 12941.375 128.6390 0.08
12 13283.3 12827.323 127.5053 0.16
13 13796.5 12361.168 122.8717 0.14
14 14572.9 11655.966 115.8619 0.13
15 14640.6 11594.534 115.2512 0.13
16 14678.4 11560.167 114.9096 0.17
17 16057.6 10307.515 102.4581 0.17
18 19371.7 7297.388 72.5370 0.22
19 20615.3 6167.911 61.3099 0.11
20 20639.6 6145.826 61.0903 0.19
21 21136.7 5694.333 56.6024 0.22
22 22256.1 4677.659 46.4966 0.16
23 23901.0 3183.636 31.6458 0.15
24 24328.3 2795.576 27.7884 0.16
25 25028.5 2159.611 21.4668 0.76
26 25870.9 1394.474 13.8613 0.10
Print of window 80: MS Spectrum
Data File : D:\DATA_MS\AUG-2022\01-08-2022-001 2022-08-01 17-25-20\QC01-2208-0003.D
=====================================================================
Acq. Operator : SYSTEM Seq. Line : 3
Acq. Instrument : ALR-QC-LCMS Location : 9
Injection Date : 8/1/2022 5:34:33 PM Inj : 1
Inj Volume : 10.000 µl
Acq. Method : D:\data_ms\AUG-2022\01-08-2022-001 2022-08-01 17-25-20\MASS FA.M
Last changed : 8/1/2022 5:25:20 PM by SYSTEM
Analysis Method : C:\CHEM32\1\METHODS\MASS FA..M
Last changed : 7/30/2022 6:34:18 PM by SYSTEM
(modified after loading)
Method Info : Mobile phase: Mobile Phase:1ml of Formic Acid in 1000ml Water:ACN (50:50
) Flow:0.5 mlFragmentor-110
Sample Info : Diluent:Methanol Expected Mas:404.5
MS Spectrum
*MSD1 SPC, time=0.194 of D:\DATA_MS\AUG-2022\01-08-2022-001 2022-08-01 17-25-20\QC01-2208-0003.D
405.2 ES-API, Pos, Scan,
100 Max: 223328
80
+ve
60
40
20
406.2
0
100 200 300 400 500 600 700 800 m/z
ALR-QC-LCMS 8/1/2022 5:37:37 PM SYSTEM Page 1 of 1
TGA
Sample: A3-523
Sample Size: 4.10010 mg
Operator:
Date of Experiment: 2023-05-13
File Path: \\Ta-pc\ta\Data\SDT\MAY 2023\ALR\ALR-

64.001
Method Log:
1: Ramp 10.00°C/min to 840.00°C
2: End of method
120
35.80°C
100.0% 105.00°C
100 98.76%
1.238%
92.52%
(3.669mg)
80
Time:9.08 min
Temperature:105°C Delta Y = 1.238%
Weight loss : 1.238% Loss on drying
From RT to 105C Time:80.24 min
60
Weight (%)
Temperature: 814.76°C
Weight loss : 92.52%
40
20
814.76°C
6.248%
-20
25 225 425 625 825
Temperature (°C) Universal V4.5A TA Instruments
QC-08 ALR LABS PVT. LTD. UV SPECTRA
Scan Spectrum Curve

2.000
1.475
231.00,1.007
276.00,0.867
Abs
0.950 213.50,0.775
0.425
-0.100
200.00 250.00 300.00 350.00 400.00
Wavelength(nm)
Instrument Performance
Model : UV-VIS Spectrophotometer
Number : 23-1950-01-0032
Spectral Bandwidth : 2.00 nm
Scan Spectrum Performance
Scan Range : 200.00 to 400.00 nm
Measure Mode : Abs
Interval : 0.50 nm
Speed : Medium
Data File : QC18-2305-007.spd
Create Date/Time : Monday, May 15, 2023 3:35:14 PM
Data Type : Original
Method File:
Analyse Note
Analyser : Administrator
Comment : A3-523
No. P/V Wavelength(nm) Abs Comment
1 Peak 276.00 0.867
1
QC-08 ALR LABS PVT. LTD. UV SPECTRA
2 Peak 231.00 1.007

3 Peak 213.50 0.775
2
Structure Elucidation Report (SER): Ozanimod (R)-
enantiomer Impurity (batch number A3-523)
NMR Study: The NMR experiments were performed in Bruker’s 400 MHZ FT-NMR
Spectrometer using DMSO-d6 Solvent. Chemical shifts were reported in delta (δ) units, parts
per million (ppm) with respect to the solvent DMSO-d6 2.50 ppm for proton and 39.5 ppm for
carbon. Coupling constants were reported in hertz (Hz). All assignments of Ozanimod (R)-
enantiomer Impurity were shown in the table below.
N
27
15
22 23 14
O N
16
13
9
O 18 8
24 21 N 10
19 17
H3 C 20
7
25 CH3 11
12
26 6
4
2
5
NH OH
3 1
HCl
1 13
Atom Label H chemical shift δ Number of Coupling constant C chemical shift
(ppm) protons (Hz) δ (ppm)
1 3.70 2 q, J=4.0 56.60
1-OH 5.29 1 t, J=4.8
2 3.01,3.06 2 m 46.50
3NH2+ 9.12 2 m
4 4.92 1 m 61.31
5 2.28,2.57 2 m 27.79
6 3.27,3.48 1 31.65
7C 144.62
8C 122.87
9 8.17 1 d, J=7.6 129.35
10 7.58 1 m 127.51
11 7.92 1 d, J=7.6 129.09
12C 139.26
13C 167.95
14N
15O
16C 173.30
17N
18C 115.86
19 8.42 1 dd, J=2.0,8.8 134.62
20 7.58 1 m 114.91
21C 162.55
22C 102.46
23 8.54 1 d, J=2.0 133.84
24 4.99 1 Sept, J=6.1 72.54
25,26 1.38 6 d, J=6.0 21.47
27C 115.25
d indicates doublet; dd-doublet of doublet; t-triplet, q-quartet; sept-septet and m, multiplet.
IR study: IR Assignment (Make:Bruker Model: Alpha +)

Wave number (Cm-1) Assignment
3410.81 -OH stretching
2928.10 Aliphatic -CH stretching
1275.09 -C-O stretching
Mass analysis: Mass data was acquired by using instrument details and mode (Make:Agilent
Model: 3120b)
Mass data of Ozanimod (R)-enantiomer impurity showed peak of protonated molecular ion at m/z
405.2 daltons.
Ozanimod (R)-enantiomer impurity
m/z Assignment
405.2 [M+H]+
Ozanimod (R)-enantiomer Impurity:- This impurity has been synthesized

using chiral starting material. The obtained product is having desired R-stereo center.
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NAME OF UNIT(S)
1 M/S KARPSCHEM LABORATORIES PRIVATE LIMITED
Name of
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No.
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Village/Town Morshi Block W.No. 17
OFFICAL ADDRESS OF ENTERPRISE Ramkrishna
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Colony
AMRAVATI , Pin
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444905
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DATE OF INCORPORATION /
01/12/2020
REGISTRATION OF ENTERPRISE
DATE OF COMMENCEMENT OF
01/12/2020
PRODUCTION/BUSINESS
SNo. NIC 2 Digit NIC 4 Digit NIC 5 Digit Activity
NATIONAL INDUSTRY 1 20 - Manufacture 2011 - 20119 - Manufacture Manufacturing

CLASSIFICATION CODE(S) of chemicals and Manufacture of of organic and
chemical products basic chemicals inorganic chemical
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DATE OF UDYAM REGISTRATION 13/03/2021

*
In case of graduation (upward/reverse) of status of an enterprise, the benefit of the Government Schemes will be availed as per the
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Testing Services and Custom Synthesis Services Related Research & Development
Date of Initial Registration 3rd April 2023

Date of this Certificate 2nd April 2024
Certificate of Compliance
This is to certify that
KARPSCHEM LABORATORIES PRIVATE LIMITED

at
Maharashtra, India
Has successfully implemented the Quality management System and been found
working satisfactorily as per the norms of “Good Manufacturing Practice” as
laid down by “World Health Organisation” which has been in conformance to
the requirements of
WHO-GMP
Manufacturing, Trading, Import and Export of Pharmaceutical Reference Standards,
Certified Analytical Standards, Reference Materials, Research Chemicals, Analytical
Testing Services and Custom Synthesis Services Related Research & Development
This certificate is issued under the following conditions:

1. It applies only to the quality system maintained in the manufacture of above
referenced Models Products.
2. The certificate remains valid until the manufacturing conditions or the quality
systems are changed and is subject to continuous surveillance according to the
WHO-GMP Guidelines
3. The certificate validity is conditioned by positive results or surveillance audits.

Date of Certification 3rd April 2024
1st Surveillance Audit Due 2nd April 2025

Karpschem Catalog 2024

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ALB205 10605-21-7 Albendazole EP Impurity E

31055-19-3 Allopurinol EP Impurity E

Hydroxyethyl Phthalyl Amlodipine

Apixaban ethyl ester impuity/ Apixaban Impurity 1

Apixaban acid impuity/ Apixaban Impurity 2

Apixaban methyl ester impuity/ Apixaban Impurity 3

O-Desmethyl Apixaban/ Apixaban Impurity 4

Apixaban chloro impurity / Apixaban Impurity 5

Apixaban Amino Acid Impurity / Apixaban Impurity 6

4,5-Dehydro Apixaban/ Apixaban Impurity 12

Apixaban IV Chloro Impurity

Apixaban Impurity 3(BMS-778960)

Apixaban Open Chain Acid

ARG100 74-79-3 L-(+)-Arginine

ARG401 2645-08-1 BENZOYL ARGININE ETHYL ESTER

Aripiprazole Related Compound B

ATN207 56392-14-4 Atenolol EP Impurity G

ATM100 82248-59-7 Atomoxetine Hydrochloride

1643684-05-2/ Atomoxetine EP Impurity D

ATM208 42142-52-9 Atomoxetine EP Impurity H

Atorvastatin calcium salt

Atorvastatin EP Impurity N/ Atorvastatin Acid t-Butyl Ester

Atorvastatin Impurity 2/ Atorvastatin Acid Methyl Ester

Azilsartan Impurity A/ Azilsartan Impurity 1

Azilsartan Impurity B/ Azilsartan Impurity 2

Azilsartan Impurity D/ Azilsartan Impurity 4

Azilsartan Impurity M/ Azilsartan Impurity 13

Azilsartan Ethyl Impurity/ Azilsartan Impurity 14

Azilsartan Ethyl Ring-opening Impurity/ Azilsartan Impurity 15

AZT100 117772-70-0 Azithromycin Dihydrate

Azithromycin EP Impurity A, AZAERYTHROMYCIN A

BNZ100 255-18-5 2H-1,2,4-Benzothiadiazine

Benzothiadiazine Related Compound A

Betahistine/ Betahistine HCl

Bisoprolol Carboxylic Acid Impurity

Brompheniramine Maleate EP Impurity C

87-62-7 / Bupivacaine EP Impurity F

Bupropion Related Compound A

Bupropion Related Compound B

Bupropion USP Related Compound C

Bupropion Related Compound D

Bupropion Related Compound E

Bupropion Related Compound F

Bupropion 2-Bromo Impurity

Bupropion Des-t-Butylamino Impurity

Bupropion Nitroso Impurity

Candesartan Bromo N1-Trityl Impurity

CRV100 99-49-0 Carvone

Celecoxib 2-Methyl Analog

Celecoxib Hydrazine Impurity

Celecoxib related compound D

948293-46-7/ Celecoxib Impurity 2

Celecoxib Related Compound C

CLX409 122-00-9 4-Methylacetophenone

346451-15-8 (base) Cetirizine EP Impurity D

Cetirizne Related Compound A

Cetirizne Related Compound B

200707-85-3 (HCl salt) Cetirizne Related Compound C

Cetirizine Methyl Ester (USP)