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Cefowin Injection 1000mg (Summary Report)

The certificate of analysis summarizes the results of quality testing on three batches of CEFOWIN INJECTION 1000mg. All batches met specifications for appearance, identification, pH of solution, particulate matter, assay, sterility, and bacterial endotoxin. The results demonstrated the batches complied with tests for retention time, constituted solution, and limits for assay of 90-115% of the label claim of 1000mg cefotaxime per vial. All batches were approved as meeting quality standards.

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Shafaq ALI
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102 views1 page

Cefowin Injection 1000mg (Summary Report)

The certificate of analysis summarizes the results of quality testing on three batches of CEFOWIN INJECTION 1000mg. All batches met specifications for appearance, identification, pH of solution, particulate matter, assay, sterility, and bacterial endotoxin. The results demonstrated the batches complied with tests for retention time, constituted solution, and limits for assay of 90-115% of the label claim of 1000mg cefotaxime per vial. All batches were approved as meeting quality standards.

Uploaded by

Shafaq ALI
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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Certificate of Analysis

SUMMARY REPORT
Product: CEFOWIN INJECTION 1000mg
TEST SPECIFICATIONS RESULTS
B.No. 007CV B.No. 044CV B.No. 036CV
Mfg.: 03-2019 Mfg.: 11-2019 Mfg.: 11-2019
Exp. : 03-2021 Exp. : 11-2021 Exp. : 11-2021
Appearance White to yellowish orange crystalline Almost white Almost white Almost white
powder. crystalline crystalline crystalline
powder. powder. powder.
Identification (HPLC) The retention time of the major peak of
Cefotaxime in the chromatogram of
Retention Retention Retention
assay preparation, corresponds to that
time Complies time Complies time Complies
exhibited in the chromatogram of the
standard preparation.
pH of solution 4.5 – 6.5 5.1 5.15 5.17
Constituted solution Complies with the test Complies Complies Complies
Particulate matter The solution is free from visible, un
Complies Complies Complies
dissolved foreign particles.
ASSAY Label Claim: Limit:
(Cefotaxime as 500mg/vial 90% - 115% 98.77% 99.22% 104.16%
sodium)

MICROBIAL TESTS
Sterility Meets the requirement of sterility test sterile sterile sterile
Bacterial Endotoxin NMT 0.2Eu/mg of ceftriaxone No gel No gel No gel
observed observed observed
(Label Claim: Cefotaxime as sodium = 1000mg/vial)

Remarks: Product tested as per USP specification.

Analyst: _______________ Manager Q.C. ______________

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