API TESTING SPECIFICATION

Name: Clobetasol Propionate BP

T.S.No.: SPEC/API/HCP-012/B/01
Issue Date: 01/03/2006

Code: HCP

CAS: 25122-46-7

Storage:Protected from light.

Supersede: SPEC/API/HCP-012/B
Date: 01/04/2002

M.F.:  C25 H32 CIFO5

M.W.: 467.0 g/mole

 


Test

 

Specification

Characters

:

White or almost white, crystalline powder.

Solubility

:

Practically insoluble in water, freely soluble in acetone, sparingly soluble in ethanol (96 percent).

Identification

:

The Infra red absorption spectrum should be concordant with reference spectrum of Clobetasol propionate CRS.

Specific optical rotation

:

+112.00 to+118.00C on Dried basis.

Related substances

:

Impurity E: Not more than 0.70%

 

:

Impurity D: Not More Than 0.50 %

 

:

Impurity B,C: Not More Than 0.30 %

 

:

Impurity A,L,M: Not More Than 0.20 %

 

:

Unspecified impurity: Not More Than 0.10 %

 

:

Total impurities: Not More Than 2.00%.

Loss on drying

:

Not more than 0.50%w/w

Sulphated Ash

:

Not more than 0.100%w/w

Assay

:

97.00 to 102.00%.w.r.t dried substance.

End of specification