API TESTING SPECIFICATION

Name: Betamethasone Valerate BP

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

Code: HBV

CAS: 2152-44-5

Storage: Store protected from light.

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

M.F.:  C27 H37 FO6

M.W.: 476.6g/mole

 


Test

 

Specification

Characters

:

A white or almost white,crystalline powder.

Solubility

:

Practically insoluble in water, freely soluble in acetone and in methylene chloride , soluble in ethanol (96 percent).

Identification

:

Test C & D OR tests A, B, E,F & G.

Identification A

:

It should comply with the test for specific optical rotation.

Identification B

:

The absorbance of the resulting solution at about 419nm should not more than 0.100Abs.

Identification C

:

The Infra red absorption spectrum should concordant with the spectrum obtained from std of Betamethasone Valerate or with the Reference Infra red spectrum graph.

Identification D

:

The principal spot in the chromatogram obtained with the test solution should be similar in position, colour in daylight, fluorescence in ultraviolet light at 365 nm and size to the principal spot in the chromatogram obtained with reference solution (a). The test should not valid unless the chromatogram obtained with reference solution (b) should show two clearly separated spots.

Identification E

:

The principal spot in each of the chromatograms obtained with test solution should be similar in position, colour in daylight, fluorescence in ultraviolet light at 365 nm and size to the principal spot in the chromatograms obtained with corresponding  working std solution. The principal spot in each of the chromatograms obtained with test solution(b) and reference solution(b) has an Rf  value distinctly lower than that of the principal spots in each of the chromatograms obtained with test solution(a) and working std solution (a).

Identification F

:

The colour should be discharged and a clear solution should remain.

Identification G

:

The test solution should be yellow and the blank should be red.

Specific optical rotation

:

Between + 75.000 and + 82.000.

Related substances

:

Max. Individual impurity should not more than 1.50%.

 

:

Any other individual impurity should not more than 1.00%.

 

:

Total impurities should not more than 3.00%.

Loss on drying

:

Not more than 0.50%

Assay

:

97.00 to 103.00%.w.r.t. dried substance.

End of specification