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PRODUCT
Fludrocortisone acetate CAS: 514-36-3
SAMPLE DATE
2023.08.12
BATCH NO.
230801
TESTED DATE
2023.09.06
CRITERIA
EP8
ITEMS
SPECIFICATION
TEST RESULT
IDENTIFICATION
A, B, C, D, E
CONFORM
CHARACTER
White or almost white crystalline powder
Almost white crystalline powder
SOLUBILITY
Practically insoluble in water, sparingly soluble in anhydrous ethanol
Conform
SPECIFIC ROTATION
+148°- +156°
+150.0°
LOSS ON DRYING
≤1.0%
0.39%
RESIDUAL SOLVENTS
DMF ≤880ppm
RELATED SUBSTANCES
Total impurities:≤1.5%
0.68%
The biggest impurity:≤1.0%
0.25%
Not more than one impurity>1.0%
MANU. DATE
August 12, 2021
RETESTED DATE
August 11, 2023
ASSAY
97.0%—103.0%
98.0%
CONCLUSION
The above product conforms to EP8.
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