API TESTING SPECIFICATION

Name: Betamethasone BP

T.S.No.: SPEC/API/HBMS-017/B/01
Issue Date: 01/03/2006

Code: HBMS

CAS: 378-44-9

Storage: Store protected from light.

Supersede: SPEC/API/ HBMS-017/B
Date: 01/04/2002

M.F.:  C22 H29 FO5

M.W.: 392.50g/mole

 

Test

 

Specification

Characters

:

A white or almost white, crystalline powder.

Solubility

:

Practically insoluble in water, sparingly soluble in ethanol, very slightly soluble in methylene chloride.

Identification

:

Test B and C OR Tests A,C,D and E.

Identification A

:

The absorbance of solution at 419 nm should not be more than 0.100 Abs.

Identification B

:

The Infra red absorption spectrum should concordant with the spectrum obtained from Betamethasone working Standard.

Identification C

:

The principal spot in the chromatogram obtained with the test solution should be similar in position, colour in day light, fluorescence in UV light at 365 nm and size to the principal spot in the chromatogram obtained with working standard solution (a). The test should not valid unless the chromatogram obtained with reference solution (b) should show two spots which may however not be completely separated.

Identification D

:

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

Identification E

:

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

Specific optical rotation

:

+118.000 to  +126.000 on dried basis

Related substance  (By HPLC )

:

Any individual impurity : Not more than 1.00%

Any other impurity : Not More Than 0.50%

Total impurity : Not more than 2.00%

Loss On Drying

:

Not more than 0.50%w/w

Assay

:

Not less than 97.00%w/w and not more than 103.00%w/w on dried substance.

End of specification