API TESTING SPECIFICATION

Name: Betamethasone Sodium Phosphate BP

T.S.No.: SPEC/API/HBSP-009/B/01
Issue Date: 01/03/2006

Code: HBSP

CAS: 151-73-5

Storage: Store in an airtight container , protected from light.

Supersede: SPEC/API/HBSP-009/B
Date: 01/04/2002

M.F.:  C22 H28 F Na2 O8 P

M.W.: 516.4g/mole

Specification

A white or almost white powder; very hygroscopic.

Freely soluble in water, slightly soluble in alcohol, practically insoluble in methylene chloride.

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

The absorbance of the resulting solution at about 450nm should not more than 0.100Abs.

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

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 spots which may however not be completely separated.

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

The test solution should yellow and the blank should red.

The solution should give reaction (a) of sodium and reaction (b) of phosphates.

Solution S should be clear and not more intensely coloured than reference solution B7.

7.50 to 9.00.

Between + 98.000 and + 104.000.

Max. Individual impurity should not more than 2.00%.

:

Any other individual impurity should not more than 1.00%.

:

Total impurities should not more than 3.00%.

Inorganic phosphates

:

Not more than 1.00%

Water

:

Not more than 8.00%

Assay

:

96.00 to 103.00%. w.r.t. anhydrous substance.