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醋酸甲基潑尼松龍，53-36-1，質檢單
CERTIFICATE OF ANALYSIS
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PRODUCT: |
Methylprednisolone Acetate |
ANALYSIS DATE: |
2020-9-5 |
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BATCH NO: |
2009001 |
DATE OF MANUFACTURING: |
2020-9-1 |
RETEST DATE: |
2023-8-31 |
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QUANTITY: |
10KG |
Packing |
/ |
DATE OF REEVALUATION: |
2023-8-31 |
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DATE OF EXPIRY: |
2023-8-31 |
STANDARD: |
USP40 |
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ITEM AND RESULT |
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Item |
Test based on |
specification |
Result |
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Appearance |
USP40 |
White or almost white Crystalline powder |
white crystalline powder |
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Identification |
USP40 |
A.IR B.UV |
Complies |
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Specific rotation |
USP40 |
+97°~+105° |
+100.57° |
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Loss on drying |
USP40 |
≤1.0% |
0.12% |
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Chromatographic purity |
USP40 |
Single impurity≤1.0% |
0.58% |
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Total impurities≤2.0% |
0.84% |
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Particle size(um) |
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90%≤20um |
Complies |
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Assay |
USP40 |
97.0%~103.0% |
98.97% |
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Conclusion |
Complies USP40 standard |
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