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CERTIFICATE OF ANALYSIS
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PRODUCT: |
Methylprednisolone |
ANALYSIS DATE: |
2019-9-5 |
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BATCH NO: |
1909001 |
DATE OF MANUFACTURING: |
2018-9-1 |
RETEST DATE: |
2021-8-31 |
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QUANTITY: |
10KG |
CAS NO: |
83-43-2 |
DATE OF REEVALUATION: |
2021-8-31 |
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DATE OF EXPIRY: |
2021-8-31 |
STANDARD: |
USP34 |
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ITEM AND RESULT |
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Item |
Test based on |
specification |
Result |
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Appearance |
USP34 |
White to practically white Crystalline powder |
Almost white crystalline powder |
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Identification |
USP34 |
A.IR B.UV C.Positive reaction |
Complies |
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Specific rotation |
USP34 |
+79°~+86° |
+82.5° |
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Loss on drying |
USP34 |
≤1.0% |
0.19% |
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Residue on ignition |
USP34 |
≤0.2% |
0.06% |
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Chromatographic purity |
USP34 |
Single impurity≤1.0% |
0.26% |
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Total impurities≤2.0% |
0.58% |
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Residual solvents |
In-house Standard |
Methanol≤0.2% Dichloromethane≤0.05% Acetone≤0.2% Ethanol≤0.3% Ethyl acetate≤0.3% |
0.02% ND ND 0.06% ND |
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Assay |
USP34 |
97.0%~103.0% |
99.1% |
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