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醋酸氟氫可的松514-36-3/COA
CERTIFICATE OF ANALYSIS
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PRODUCT |
Fludrocortisone acetate CAS: 514-36-3 |
SAMPLE DATE |
2021.08.12 |
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|
BATCH NO. |
210801 |
TESTED DATE |
2021.09.06 |
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CRITERIA |
EP8 |
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ITEMS |
SPECIFICATION |
TEST RESULT |
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IDENTIFICATION |
A, B, C, D, E |
CONFORM |
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CHARACTER |
White or almost white crystalline powder |
Almost white crystalline powder |
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|
SOLUBILITY |
Practically insoluble in water, sparingly soluble in anhydrous ethanol |
Conform |
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SPECIFIC ROTATION |
+148°- +156° |
+150.0° |
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LOSS ON DRYING |
≤1.0% |
0.39% |
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RESIDUAL SOLVENTS |
DMF ≤880ppm |
Conform |
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RELATED SUBSTANCES |
Total impurities：≤1.5% |
0.68% |
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The biggest impurity：≤1.0% |
0.25% |
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Not more than one impurity＞1.0% |
Conform |
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MANU. DATE |
August 12, 2021 |
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RETESTED DATE |
August 11, 2023 |
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ASSAY |
97.0%—103.0% |
98.0% |
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CONCLUSION |
The above product conforms to EP8. |
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