API TESTING SPECIFICATION

Name: Clobetasol Propionate USP

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

Code: HCP

CAS: 25122-46-7

Storage:Preserve in tight, Light-resistant containers.

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

M.F.:  C25 H32 CIFO5

M.W.: 466.97 g/mole

 

Test

 

Specification

Description

:

White to cream, crystalline powder.

Solubility

:

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

Identification – A

:

The Infra red absorption spectrum should be concordant with the spectrum obtained from std of Clobetasol propionate.

Melting range

:

Approximately 196.0 0C.

Specific rotation

:

Between + 98.00 and + 104.000.

Loss on drying

:

Not more than 2.00%.

Residue on ignition

:

Not more than 0.100%.

Heavy metals

:

20 μg  per g. (Not more than 20 ppm)

Chromatographic purity

:

Any Individual impurity should not more than 1.00%.

 

:

Total impurities should not more than 2.50%.

Residual solvents

:

Methanol not more than 3000.00 ppm.

 

:

Acetone not more than 5000.00 ppm.

Residual solvents

:

Methylene Chloride not more than 600.00 ppm

 

:

Ethyl acetate not more than 5000.00 ppm.

 

:

Chloroform not more than 60.00 ppm

 

:

Pyridine not more than 200.00 ppm.

 

:

Dimethylformamide not more than 880.00 ppm.

Assay

:

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

*In-house tests

:

(As per customer requirement)

*Light Absorption

:

NMT 0.075 abs. (5% w/v solution in dioxane, Read at 430 nm)

*Microbial limits

:

Total Microbial counts 100 cfu/g

 

:

Absence of Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella species.

*Particle size

:

90% < 20 micron; 100% < 50 micron.

End of specification