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COA Lincomycin 180622051

The Certificate of Analysis for Lincomycin Hydrochloride (Batch No. 180622051) from Topfond Pharmaceuticals confirms that the sample meets all specifications set by USP 41. The analysis includes tests on characteristics, solubility, identification, specific rotation, pH, water determination, limit of Lincomycin B, and assay potency. The document is prepared and reviewed by R&D specialists, with attachments including IR identification charts and HPLC chromatograms.

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18 views3 pages

COA Lincomycin 180622051

The Certificate of Analysis for Lincomycin Hydrochloride (Batch No. 180622051) from Topfond Pharmaceuticals confirms that the sample meets all specifications set by USP 41. The analysis includes tests on characteristics, solubility, identification, specific rotation, pH, water determination, limit of Lincomycin B, and assay potency. The document is prepared and reviewed by R&D specialists, with attachments including IR identification charts and HPLC chromatograms.

Uploaded by

jesuskirolos76
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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R&D department

Code No. RDF -733-13


CERTIFICATE OF ANALYSIS

Chemical Name Lincomycin Batch No. 180622051


Hydrochloride

Supplier Topfond Quantity 1.0 Kg


Pharmaceuticals Co.,
Ltd

Mfg date JUN-2018 Method Reference USP 41

Re-test/Expiry date JUN-2021 Supplier method Reference USP 41

Page 1/3
Test Specification
Results Test Code

1- Characteristics
A) Appearance White or practically white, crystalline White or practically white,
powder. Is odorless or has a faint odor crystalline powder. Is Visual inspection
. Is stable in the presence of air and odorless or has a faint
light. odor . Is stable in the
presence of air and light.
B) Solubility
GT-SOL-1.1-01-0
Freely Soluble in water , soluble in Freely Soluble in water ,
Dimethylformamide , very slightly soluble in
soluble in acetone Dimethylformamide , very
slightly soluble in acetone

2- Identification
A) Infrared absorption Comparison Lincomycin Hydrochloride
spectrophotometry RS Complies GT-IR-1.1-01-0
R&D department
Code No. RDF -733-13
CERTIFICATE OF ANALYSIS

Chemical Name Lincomycin Batch No. 180622051


Hydrochloride

Supplier Topfond Quantity 1.0 Kg


Pharmaceuticals Co.,
Ltd

Mfg date JUN-2018 Method Reference USP 41

Re-test/Expiry date JUN-2021 Supplier method Reference USP 41

Page 2/3
Specific Rotation Between +135oC and +150oC GT-OR-1.2-01-0
+138.143
PH Between 3.0 and 5.5 in a solution (1 GT-pH-1.2-01-0
in10) 4.51
Water determination Between 3% and 6% GT-WD-1.2-01-0
4.1060%
Limit of Lincomycin B Area of Lincomycin B is not greater GT-LC-1.2-01-0
than 5% than the sum of the areas of Lincomycin B area :
the lincomycin B peak and the
lincomycin peak 236159

5% of the sum of

Lincomycin and

Lincomycin B area peaks:

398601.8

Assay Lincomycin Hydrochloride has a GT-LC-1.2-01-0


potency equivalent to not less than 848.0345436
790µg of Lincomycin (C18H34N2O6S)
per mg

Page 3/3
R&D department
Code No. RDF -733-13
CERTIFICATE OF ANALYSIS

Chemical Name Lincomycin Batch No. 180622051


Hydrochloride

Supplier Topfond Quantity 1.0 Kg


Pharmaceuticals Co.,
Ltd

Mfg date JUN-2018 Method Reference USP 41

Re-test/Expiry date JUN-2021 Supplier method Reference USP 41

Conclusion: The Sample meets the specifications.

Attachments: • Charts of Lincomycin Hydrochloride identification by IR

•Chromatograms of Assay by HPLC

•Chromatograms of Limit of Lincomycin B by HPLC

•Water determination report by karl fischer titration

Prepared by:Dr. Karim Emad Reviewed by: Dr. George Ashraf Approved by: Dr. Laila GadElRub

Position :R&D Specialist Position : R&D executive Position :R&D director

Signature: Signature: Signature:

Date: Date: Date:

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