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甲潑尼松半琥珀酸酯COA/27303-92-0
CERTIFICATE OF ANALYSIS
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Product name |
Meprednisone Hemisuccinate |
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Batch No. |
220801 |
Quantity |
53.50kg |
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Mfg. Date |
Aug.,25, 2022 |
Expiry date |
Aug.,24, 2025 |
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Specification |
Enterprise Standard |
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Items |
Standard |
Results |
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Description |
white or almost white crystalline powder |
white crystalline powder |
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Identification |
A(IR), B(HPLC) |
complies |
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Loss on drying |
≤1.0% |
0.31% |
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Residue on ignition |
≤0.1% |
0.03% |
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Light absorption |
310~330 |
323.7 |
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Specific rotation |
+174º~ + 182º |
+178.8º |
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Related substance |
single impurity not more than 1.0% |
0.52% |
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total impurities not more than 2.0% |
0.68% |
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Assay |
98.0%~102.0% |
99.2% |
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Particle size |
90%≤20um |
complies |
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80%≤10um |
complies |
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CONCLUSION:THIS BATCH OF PRODUCT CONFORM TO ENTERPRISE STANDARD |
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Analyst |
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Checker |
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Approved by |
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