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CERTIFICATE OF ANALYSIS
Product Name |
Benzylpenicillin Potassium Sterile |
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Batch No. |
220574 |
MFG. Date |
2022/05/26 |
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Report Date |
2022/06/12 |
Exp. Date |
2024/05/25 |
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Package |
316Kg/bag |
Quantity |
220 bag |
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ITEMS |
SPECIFICATIONS |
RESULTS |
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Characters |
White or almost white crystalline powder |
White crystalline powder |
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Identification |
Complies |
Complies |
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Tests |
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PH |
5.5-7.5 |
6.44 |
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Specific optical rotation |
+270°~ +300° |
+295° |
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Absorbance |
325nm |
≤0.10 |
0.01 |
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280nm |
≤0.10 |
0.02 |
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264nm |
0.80-0.88 |
0.84 |
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Related substances |
≤1.0% |
0.1% |
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Loss on drying |
≤1.0% |
0.09% |
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Sterility |
Complies |
Complies |
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Bacterial endoloxins |
<0.16IU/mg |
Complies |
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Assay calculated as anhydrous substance |
96.0%~102.0% |
99.3% |
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Conclusion |
Complies with EP 5th standard |