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CERTIFICATE OF ANALYSIS
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Product Name |
Chloramphenicol |
Batch No. |
20190805 |
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MFG. Date |
Aug 05,2019 |
Exp. Date |
Aug 04,2021 |
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|
Quantity |
250kg |
Batch size |
25kg |
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Test Items |
Specifications |
Results |
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Characteristics |
Fine white or grayish white or yellowish white needle-like crystals or elongated plates |
Yellowish whie needle-like crystals or elongated plates |
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Identification |
Positive |
Positive |
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Melting Point |
149～153oC |
150.0-152.3oC |
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Assay |
98.5～102% |
99.6% |
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Loss on drying |
≤0.5% |
0.18% |
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Residue on Ignition |
≤0.10% |
0.06% |
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Acidity or Alkalinity(PH) |
5.0～7.5 |
5.30 |
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Specific Rotation |
+18.5～+20.5o |
+19.1o |
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Heavy Metals |
≤0.001% |
≤0.001% |
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Related Substances |
The any secondary spot≤0.5% Total≤2.0% |
The any secondary spot≤0.5% Total≤2.0% |
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Chloride |
≤0.005% |
≤0.005% |
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Crystallinity |
Meets the requirements |
Meets the requirements |
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Conclusion |
The above product complies with the standard EP9.0/BP2013/USP36. |
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