Stage- I : LOS-I Store in well closed containers below 25°C

Send the sample of Potassium carbonate powder to QC for checking LOD .(LOD NMT 2.0%)
Dry potassium carbonate in VTD-8109 If it is not in limit.

T-8103-5KL-SS 700 lit Fresh DMF

Manual 350 kg BMC RE-8109

Manual 267.75 Kg potasium carbonate
SS-316
6000L
stirr/cool/Rxn monitoring
Manual 252 Kg BCFI 10-15° C
Slow Addition
1135

T-7103-5KL-SS/ Fresh Methanol /

1750 Lit
Rec Methanol
V-8119 1750 Lit P.Water RE-8109
SS-316
6000L
Recirculation line with Pump Stirr
10-15° C

4635

CF-8104
SS-316

60''

Main filtration
25-30°C

490

RE-8109
1400 lit Pur. Water SS-316
490 Kg Wet cake 6000L
Stirr
25-30°C
I water leaching

1645

CF-8104
350 Lit Pur. Water SS-316
60''
I water leaching filtration
25-30°C

490

RE-8117
SS-316
1050 lit Pur. Water 2000 L
490 Kg Wet cake Stirr
25-30°C
II/III water leaching
 1295

CF-8104
660.0 Lit Pur. Water SS-316
60''
II/III water leaching filtration
25-30°C

465.5

RE-8117
Stirr
1400 lit Pur. Water 2000 L
466 Kg Wet cake 25-30°C

25-30°C
IV water leaching

1633

CF-8104
175 Lit P.Water SS-316
175 Lit Methanol 60''
Note: During 2nd spray wash, Methanol+Water solution IV water leaching filtration
spray wash is to be given. 25-30°C

483
RE-8117
SS-316
T-7103-5KL-SS 1400 Lit Methanol 2000 L
483 Kg Wet cake Slurry prep/Heat/Reflux
65-70°C

1642
RE-8117
SS-316
2000 L
Cooling/Stirring
0-5°C

1642
Jacketted Vessel CF-8108/ CF-8104

SS-316
V-8117 SS 1.0 KL
350 Lit Chilled Methanol 60"
Filtration
0-5°C

420
RVD-8101
SS-316
1500 L
Drying
55-60°C

409.5
LOS-I
Yield range: Between 1.10-1.38 kg/kg LOS-I of BMC
Send sample to QC after every 45 mins.
min vol
min vol max vol max vol ratio
BMC Content NMT 1.0%. ratio
400 700 1134.875 2 3.2

5 mts
Lit

1134.875 4635 3.2425 13.2

Lit

CFMLT-8111-1 KL-SS
ML 4158 Lit 490 0 1.4

Methanol 1715 Lit

DMF 686 Lit

Water 1750 Lit
Others 7 Lit
Kg
11.880375 1400 1645 4 4.7

Lit 1400 1645 4 4.7

ML

Water

kg
Lit 1050 1295 3 3.7

ML

Water

kg

Lit

ML

Water

Kg
1400 1642 4 4.7
condenser available

5 mts

Lit
1642 1642 4.69 4.7

Lit
420 0 1.2

CFMLT-8120-SS-500 L
ML+WML(MeOH)
1782 Lit

Kg
409.5 0 1.2

0 mts

Kg
.10-1.38 kg/kg LOS-I of BMC
C-7102 Rec MeOH T-7125-MS-5KL T-8108-SS-5KL
RE-8111 DMF-II Cut T-7131-MS-5KL RE-8111 REC. DMF T-7129-5KL-SS V-8103-1.5KL-SS

60 % DMF recovery to be considered.

 0.405
4.455

C-7102 Rec MeOH

 Stage II: Los-II Store in well closed containers below 25°C

AV-8101/ RE-8102

T-7103-5KL-MS 550 Lit Fresh Methanol /

SS-316
Rec Methanol
27.5 Lit P. Water 60 L
Manual 2.75 Kg sod.hydroxide Stirr/Cool
Manual 44 Kg sod.borohydride 25-35°C/10-15°C
10 mts
601 Lit

2750 Lit Methanol RE-8113

550 Kg Los-I SS-316 send sample to QC after every 60 mins
5000 L Los-I content not more than 0.5%
Charging/Chilling/Heating
25-30°/10-20°/65-70°C
10 mts
3626 Lit

RE-8113
1100 Lit Pur. Water SS-316
5000 L
Cooling/Charging/Stirr
20-25°C

4726 Lit
ML-WML T-8120-1KL-SS304
CF-8109 4726
V-8101A-1 KL- S 275 Lit Methanol SS-316 Methanol+water
60'' Water 1100
Filter Methanol 3575
20-25°C
0 mts
Wet cake 550 kg
VTD-8109/VTD-8102 Send sample A/4 hrs
SS-316 Water content NMT 0.40%
48 trays
Hot Water Temp 40-55°C
0 mts
528 Kg
Los-II

Yield :0.90-1.00 kg of Dry LOSS-II O/P in Kg of I/P of LOS-I in Kg

 MIN VOL MAX VOL MIN VOL MAX VOL
in lit in lit
550 601 1 1.1

2750 3626 5 6.6

to QC after every 60 mins

not more than 0.5%

3626 4726 6.6 8.6

T-8120-1KL-SS304 550 1.0

Lit
COMPOSITION
0.23
0.77

ent NMT 0.40% 528 0.96

I/P of LOS-I in Kg
 Stage III:Los-III Crude Store in well closed containers below 25°C

T-7134-10KL-MS /
2328 Lit MIBK / Rec MIBK RE-8123
7176 A/B-10KL-SS send sample to QC after
SS-316 24 HR, then after every
465.69 Kg LOS-II 8000L 2 HR,till LOS-II content
Manual 475.00 Kg Sodium Azide Stirr/heat/cool is NMT-0.50%
Manual 1024.52 Kg Triethylamine-HCL 25-30°/100-110°C/10-15°
512.259 Lit 10 mts
3311 lit

RE-8118
1630 Lit Purified Water SS-316
512.26 Kg Sodium nitrile 2000L
0.466 Kg Sodium hydrosulphite Chilling
256.362345 lit 10-15°/10-20°C
5mts
5197 lit

RE-8122
1250 Lit Purified water MSGL
V-8122A-PVDF-4KL
1250 Lit HCl 12500L
Stirr/cool
2927 Purified water 10-35°C/10-20°c/5-10°c
Adjust ph-(3.8-4.5) 5mts
10624 lit

4191.21 Lit Purified water CF-8110 ML-WML

3 times washing HALAR
4 lots 60'' MIBK
Filtration TEA
21.47351242 10-15° C Water

Wet cake 745 Kg

T-8110-5KL-SS 2329 Lit Ethyl Acetate RE-8104

745 Kg Wet Cake SS-316
T-8103-5KL-SS 232.845 Lit F. DMF 5000L
Charge/Heat/Cool
25-30°C/65-80°/5-10°C

2934 lit
V-8104-1.5KL-SS 466 Lit Ethyl acetate CF-8106 ML-WML
Chilled EA washing HALAR
60'' Ind imp at RRT 1.59 NMT 0.07%
FILTER Any other ind imp NMT 0.10%
10-15° C Total imp NMT 0.50%

Wet cake 451.7193 Kg

D-8108/8109
Send sample to QC SS-316
after every 4-hour drying 48 Trays
Unload the product Drying
when LOD is NMT 0.90% Hot Water Temp 45-55 c

Dry Qty 428.4348 kg

Los-III Crude

Yield :0.85-1.11 kg of LOS-III crude/Kg of LOSS-II

 MIN vol MAX vol MIN vol max vol
in lit in lit
2328 3311.05 5 7.109995

send sample to QC after

24 HR, then after every
2 HR,till LOS-II content
is NMT-0.50%

` 3311.05 5197.33 7.11 11.16

14016
5197.33 10624.11 11.16 22.81

449.98507

800
745.10 1.60
15615

MLT-8121-0.5KL-PPFRP
14443 Lit
1979.1825 Lit 98
512.259 Lit
11951 Lit 2

2328.96 2934.36 5.00 6.30

 T-9504-1.2KL-SS304
DMF 221.20275 Lit
EA 2952.9869 Lit
3174 lit 0.069687944719
Ind imp at RRT 1.59 NMT 0.07% 6.968794471912
Any other ind imp NMT 0.10% 93.03120552809 451.72 0.97
Total imp NMT 0.50%

23.2845

0.92

g of LOSS-II
 Store in well closed containers below 25°C
Stage IV: Los -III Pure

T-7101-5KL-SS 960 Lit F. IPA/ Rec IPA RE-8102

1440 Lit Pur. Water SS-316
3000L
0.4 Charging/Stirring
25-30°C
2400 Lit
RE-8102
5.00 Kg celite SS-316
3000L
Charging/Stirring
25-30°C
2403 Lit
SF-8101/CTF-8101
SS-316/18 "
20"
2403 Lit
Manual 30 Kg NaOH RE-8102
300 Kg Los-III Crude SS-316
15.00 KG Activated carbon 3000L Wash celite bed with IPA+Water mixt
240 Lit IPA+Water Mixture Charging/Filter
15 Kg Activated Carbon 25-30°C
360 Lit IPA+Water Mixture
2575 Lit
SP-01/CTF-01
SS-316/18 "
20"
2575 Lit
Prep soln in RE-8110 n unload in a PPFRP vessel RE-8110
240 Lit Purified water MSGL
80 Lit HCl 5000L
V-8121-0.5KL-PPFRP Chill/Adjust pH pH- 4.0-4.5
15-20°C
3502.54 Lit
0.25 RE-8110
MSGL
5000L
Stirr
15-20°C
3502.54 Lit
 CF-8102 CFMLT-8112-500 L-PPFRP
Halar Ml-WML 3152
48'' 38.067606
Filtration
15-20° C
330 kg
RE-8101
1500 Lit Purified water MSGL
330 Kg Wet cake 3000 L
Stirr
25-30°C

1665.00 Lit
3000 Lit Purified water CF-8106 ML-WML 4249
Spray wash in 2 lots SS CFMLT- 9504-1.2KL-SS316
60''
Filtration
25-30° C
315 kg
D-8102
SS-316
48 trays
Hot Water
Hot Water Temp 50-55°C
285 kg
Los-III Pure
Yield :0.90-0.98 kg/kg
 MIN VOL MAX VOL MIN VOL MAX VOL
in lit in lit

960 2400 3.20 8.00

2400 2403 8.00 8.01

2403 2575 8.01 8.58

e bed with IPA+Water mixture. 240 248 0.80 0.83

360 360 1.20 1.20

2575 3503 8.58 11.68

3503 3503 11.68 11.68

CFMLT-8112-500 L-PPFRP
lit 330 1.10

1500 1665 5.00 5.55

Lit ETP 315 1.05

CFMLT- 9504-1.2KL-SS316

285 0.95
 RE-8107
F.IPA T-7101 IPA 2695 Lit SS-316
R.IPA T-7173A/B 4 KL
KOH 3.3 kg TEMP:25-30°C
LOS III PURE 275 kg STIR=30-60MIN
IPA 330 Lit
3164.15

CTF-7113/14/15
SS316/HALAR/SS316
20"/20"/20"

3164.15

RE-7112
SS-316
5KL
TEMP:25-30°C
STIR=30-60MIN

V-7106
SS316 1.5 KL
TEMP=NMT 45°C send sample to QC
U/V DIST water content NMT 0.50%
412.5 if fail charge IPA again 825 L
 RE-7112
n-Heptane 1650 Lit SS316 5KL
TEMP:NMT 45 /30-35°C
cooling
TEMP:23-30°C
TIME=120-240 MIN
2062.5

LOT I
CF-7105
V-7121 SS316
IPA+n-HEPTANE 241 Lit 60"
TEMP=25-30°C

150 kg

LOT-II
CF-7105
From V-7121 SS316
IPA 16 lit 60"
n-HEPTANE 95 Lit TEMP=25-30°C

CF-7105
FROM V-7121 & RE-7112 SS316
IPA +n-Heptane 111 Lit 60"
TEMP=25-30°C

299.9975 kg
VTD-7103
SS-316
48 TRAYS Send sample to QC
TIME=NLT 60 MIN water content is NMT 0.50%
HWT 45-55°C LOD is NMT 0.40%
 280
MM-8104
SS-316
100 Kg/Hr

274.5
SFT-7101
SS-316
500 mm

275
`

Between 247.5-299.75 kg
Yield: Betn 0.90- 1.09Kg/Kg of LOS III pure
 MIN.Vol MAX Vol
2695 3303.3

3303.3 3303.3

3303.3 412.5

send sample to QC
water content NMT 0.50%
if fail charge IPA again 825 Lit
 412.5 2062.5

CFMLT-7111
2303
80%

CFMLT-7111

CFMLT-7111
2410.64 to SRU

299.9975

Send sample to QC
water content is NMT 0.50%
LOD is NMT 0.40%
 280

279.5
 Losartan Potassium (Amorphous)

RE-8115
Purified water 640 Lit SS-316
Stirring
Potassium hydroxide 15.58 Kg 1.2KL
Stir till clear soln obtained Temp-25-30 ̊C
30 min/60-90MIN
LOS-III PURE 100 Kg
Stir till clear soln obtained

SF-8104/CTF-8104
18"/20"

CTF-7107/71089 V-7114-1KL-SS316
V-7115-1KL-SS316

Purified water 100 Lit RE-8115

SS-316
Stirring
1.2KL

SF-8104/CTF-8104
18"/20"

CTF-7107/71089 V-7114-1KL-SS316
V-7115-1KL-SS316

755.56 Lit
V-7114-1KL-SS316 SD-7102/SD-7103
V-7115-1KL-SS316 SS-316
25kg/hr ,45 Kg/Hr

S-7101
SS-316
500mm
100 Kg
yield :NLT-0.60 AND NMT-1.08 Kg/Kg of LOSS-III Pure

`
Min Vol Max.vol

640 655.58 6.4 6.5558

655.58 755.58

755.58 755.58

100