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Ami Lifesciences Pvt- Ltd.

ctN - u241 1 oGJ1 994PTC021470
7'nFloor, Lilleria 1038, Gotri SevasiRoad,
Vadodara-390021 Gujarat lndia.
Tel.:+e1-265-2323046,2332104'Fax:+e1-265-2313523
E-mail : mail@amilifesciences.com

CERTIFICATE OF' ANALYSIS

.

(Finish Product)
Website : wwwamilifesciences.com
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Product Name TADALAFIL USP

Batch No. TDL/s0030723 A.R. No. z FP23/00894

Mfg. Date JUL-23 Date : JUN-28

Expiry/Retest
Approved Qty. 159.60 Kg Date of analysis z 07.07.23

Sr.
Test Specifications Results
No.
I Description White or almost white powder. White powder
Freely soluble in dimethyl sulfoxide, Freely soluble in dimethyl sulfoxide,
slightly soluble in methylene chloride. slightly soluble in methylene
2 Solubility
Practically insoluble in water. chloride. Practically insoluble in
water.
Identification
i) By IR The IR absorption spectrum of The IR absorption spectrum of
Tadalafil must be concordant with that Tadalafil concordant with that of
of spectrum obtained from standard. spectrum obtained from standard
J ii) By HPLC The retention time of the major peak The retention time of the major peak
(Enantiomeric and of the sample solution corresponds to of the sample solution corresponds to
Diastereomeric purity) that of the identification solution, as that of the identification solution, as
obtained in the test for Enantiomeric obtained in the test for Enantiomeric
and Diastereomeric purity. and Diastereomeric ourity
4 Residue on ignition NMT: 0.10 %w/w 0.07 o/ow/w
Organic impurities
5 )tndividual impurity NMT :0.1Yo i BDL
)Total impurities NMT :0.3 %o BDL
Enantiomeric and Diastereomeric
Purity
6 )6&l2aS Diastereomer NMT :0.1%o 0.03 %
)65,l2aS Enantiomer NMT :0.1%o ND
)65,l2aR Diastereomer NMT : 0.1% ND
7 Loss on drying NMT :0.5 %owlw 0.15 o/ow/w

Prepared by Checked by Approved by

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Date
72=
23
12, o-1,
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Date { )--o T-va

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Date l?rO+'2
Name Vishnu Patel Name Jagdish Rank Name Arabinda Sahoo
Designation/ Dy.Manager Designation/ Manager Designation/ Manager
Department Quality Control Department Quality Control Department Quality Assurance
Pase No.: I of 2 Format No.: OCD074/['/0rl05
FACTORY:Block N0.82/B, ECP Road, At & Post : Karakhadi-391450, Taluka: Padra, District: Vadodara, Gujarat, lNDlA. Tel.: +91-2662-273312 . Fax: +91-2662-273401
Aqli"L_if9,?Sig:lges
Ami Lifesciences Pvl. Ltd.
crN . u241 1oGJ1 994PTCO21470
7'nFloor, Lilleria 1038, Gotrisevasi Road,
Vadodara-390021 Gujarat lndia.
Tel.: +e1-265'2323046,2332104
E-mail : mail@amilifesciences.com

CERTIFICATE OF ANALYSIS
.
'Fax :+e1'265-2313523
Website : www.amilifesciences.com

(Finish Product)
#
ISOQAR
K4,I;:,-ii.lti::ls I
0026

Product Name TADALAFIL USP

Batch No. TDL|50030723 A.R. No. z FP23100894

Mfg. Date JUL-23 Date : JUN-28

Expiry/Retest
Approved Qty. 159.60 Kg Date of analysis z 07.07.23

Sr.
Test Specifications Results
No.
Assay by HPLC
8 Between 97.5 % and 102.5 %owlw 99.3 Yowlw
(on dried basis)
ADDITIONAL TEST
Residual Solvents*
)Methanol NMT:3000 ppm ND
9
)Isopropyl Alcohol NMT: 5000 ppm ND
)Tetrahydrofuran NMT :720 ppm ND
l0 Acetic Acid Content By GC* NMT: 5000 ppm ND

Remarks: The product conforms as per Specification No.: FPS/TDL/03i00.

6R,l2aS Diastereomer: (6R,12aS)-6-(1,3-benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino [1',2':1,6]

pyrido[3,4-b] indole- 1,4-dione
6S,12aS Enantiomer: (6S, l2aS)-6-(1,3-benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino fl',2':1,61
pyrido[3,4-b] indole-1,4-dione .:.

6S,l2aRDiastereomer: (65, 12aR)-6-(1,3-benzodioxol-5-yl)-2-methyl-2,3;6,7,12,12a-hexahydropyrazinofl',2':1,6f

pyrido[3,4-b] indole- 1,4-dione

"*" Indicates in house method

ff'
Prepared by Checked by Approved by

Sign

Date f
71>-
z. o-t e_j
Sign

Date
V
l'L-oTw
Sign

Date \ >-'D+'2--3
Name Vishnu Patel Name Jagdish Rank Name Arabinda Sahoo
Designation/ Dy.Manager Designation/ Manager Designation/ Manager
Department Quality Control Department Quality Control Department Quality Assurance
Pase No.: 2 of 2 tr'ormat No. : OCD07 4tF 102 I 05
FACTORY :Block No. 82/B, ECP Road, At & Post : Karakhadi-391450, Taluka: Padra, District : Vadodara, Gujarat, lNDlA. Tel.: +91-2662-273312 . Fax : +9'1-2662-273401