API TESTING SPECIFICATION

Name: Betamethasone Valerate USP

T.S.No.: SPEC/API/HBV-010/D/01
Issue Date: 01/03/2006

Code: HBV

CAS: 2152-44-5

Storage: Preserve in tight containers.

Supersede: SPEC/API/HBV-010/D
Date: 01/04/2002

M.F.:  C27 H37 FO6

M.W.: 476.59g/mole

 

Test

 

Specification

Characters

:

White to practically white, odourless powder. It should melt at about 190.00C, with decomposition.

Solubility

:

Practically insoluble in water; freely soluble in acetone and in chloroform; soluble in alcohol; slightly soluble in benzene and in ether.

Identification A     (By IR)

:

The Infra red absorption spectrum should concordant with the spectrum obtained from working std of Betamethasone valerate or with the reference Infra red spectrum graph.

Identification B     (By TLC)

:

The Rf value of the principal spot in the chromatogram obtained from test solution should correspond to that obtained from Working standard solution of Betamethasone valerate.

Specific Rotation

:

Between + 75.000 to + 82.000 on dried basis.

Loss on drying

:

Not more than 0.50%w/w.

Residue on Ignition

:

Not more Than 0.200%w/w.

Chromatographic Purity ( HPLC )

:

Any Individual Impurity : Not more than 1.00%
Total Impurities : Not more than 2.00%.

Residual solvents

:

Acetone not more than 5000.00 ppm.
Methylene chloride not more than 600.00 ppm.
Ethyl acetate not more than 5000.00 ppm.

Assay

:

Not less then 97.00 % w/w and not more then 103.00% w/w, on dried basis.

In-house test

:

(As per customer’s requirement)

Particle size

:

100 % < 20 micron

End of specification