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醋酸氟氢可的松514-36-3
发布日期:2024/3/25 10:20:26发布人:武汉东康源科技有限公司

CERTIFICATE OF ANALYSIS

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

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.


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