API TESTING SPECIFICATION

Name: Beclometasone Dipropionate BP (Anhydrous)

T.S.No.: SPEC/API/HBMD-011/D/01
Issue Date: 01/03/2006

Code: HBMD

CAS: 5534-09-8

Storage: Store protected from light.

Supersede: SPEC/API/HBMD-011/D
Date: 01/04/2002

M.F.: C28 H37 CIO7

M.W.: 521.1 g/mole

 


Test

 

Specification

Characters

:

White or almost white, crystalline powder.

Solubility

:

Practically insoluble in water, freely soluble in acetone, sparingly soluble in ethanol (96 per cent).

Identification

:

Test – A, B & C

Test – A

:

The Infra red absorption spectrum should be concordant with the spectrum obtained from std of Beclomethasone Dipropionate.

Test – B

:

The solution gives the reaction (a) of chlorides.

Test – C

:

Should complies with loss on drying test.

Specific rotation

:

Between + 108.00 and + 115.000.

Related substances

:

 

Impurity B,L 

:

Not More Than 0.80%

Impurity M

:

Not More Than 0.50%

Impurity A, D

:

Not More Than 0.30%

Impurity C

:

Not More Than 0.10%

Unspecified Impurity

:

Not More Than 0.10%

Total impurities

:

Not More Than 1.50 %.

Loss on drying

:

Not more than 0.50%.

Assay

:

96.00 to 102.00% w.r.t. dried substance.

*In-house tests

:

(As per customer requirement)

*Particle size

:

90.00% < 10 micron, 99.00% < 50 micron.

End of specification