Product  name

Clobetasol propionate 

Batch No.

200302

Quantity

100.0kg

Mfg. Date

Mar.,21, 2020

Expiry date

Mar.,20, 2023

Specification

USP38

Items

Standard

Results

Description              

White or almost white crystalline powder

almost white crystalline  powder

Solubility

Practically insoluble in water,slightly soluble in benzene and diethyl ether ,sparingly soluble ethanol, soluble in acetone and in dimethyl sulfoxide, in chloroform, in methanol and in dioxane

Complies

Identification (IR)           

Complies with the Standard    

Complies

Specific Rotation

+98°～+104°              

+101.9°

Melting point                              

about 196℃

193.5～194.5℃

Loss on drying                              

Max.2.0%

0.07%

Residue on ignition                           

max. 0.1%

0.04%

Heavy Metals                             

max.20ppm

Complies

Related Substances

(HPLC)

-Single impurity

N.m.t 1.0%

0.12%

-Sum impurity

N.m.t 2.5%

0.18%

Organic volatile impurities

THF

Not more than 720ppm

Complies

Methanol

Not more than 3000ppm

Complies

DMF

Not more than 880ppm

Complies

Pyridine

Not more than 200ppm

Complies

Dichloromethane

Not more than 600ppm

Complies

Ethanol

Not more than 5000ppm

Complies

Acetone

Not more than 5000ppm

Complies

Assay(HPLC,basis on drying)

97.0%～102.0%

99.4%

Packaging and storage: Preserve in tight, light-resistant containers.

Conclusion: The test product complies with the requirements of USP38.