PRODUCT

Fludrocortisone acetate CAS: 514-36-3

SAMPLE DATE

2021.08.12

BATCH NO.

210801

TESTED DATE

2021.09.06

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

Conform

RELATED SUBSTANCES

Total impurities：≤1.5%

0.68%

The biggest impurity：≤1.0%

0.25%

Not more than one impurity＞1.0%

Conform

MANU. DATE

August 12, 2021

RETESTED DATE

August 11, 2023

ASSAY

97.0%—103.0%

98.0%

CONCLUSION

The above product conforms to EP8.