API TESTING SPECIFICATION

Name: Betamethasone Dipropionate BP.

T.S.No.: SPEC/API/HBD-008/B/01
Issue Date: 01/03/2006

Code: HBD

CAS: 5593-20-4

Storage: Store protected from light.

Supersede: SPEC/API/HBD-008/B
Date: 01/04/2002

M.F.:  C28 H37 FO7

M.W.: 504.60 g/mole

 

Test

 

Specification

Characters

:

A white or almost white, crystalline powder.

Solubility

:

Practically insoluble in water, freely soluble in acetone and in methylene chloride, sparingly soluble in alcohol.

Identification

:

Test B & C or test A, D, E & F

Identification A

:

The absorbance of the resulting solution at 419nm should not be more than 0.100 abs.

Identification B

:

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

Identification C

:

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 D

:

The principal spot in each of the chromatograms obtained with the test solutions 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 the corresponding reference 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 reference solution (a).

Identification E

:

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

Identification F

:

The test solution should yellow and the blank should red.

Specific optical rotation

:

Between + 63.000 and + 70.000.

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 2.50%.

Loss on drying

:

Not more than 1.00%.w\w.

Assay

:

97.00 to 103.00%.w/w.

*In-house tests

:

(As per customer requirement)

*Particle size

:

90.00% less than 10 micron.

 

:

99.00% less than 50 micron.
End of specification