API TESTING SPECIFICATION

Name: Betamethasone Dipropionate USP

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

Code: HBD

CAS: 5593-20-4

Storage:Preserve in tight containers. Store at 250, excursions permitted between 150C and 300C.

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

M.F.:  C28 H37 FO7

M.W.: 504.6 g/mole

 

Test

 

Specification

Description

:

White to cream-white, odorless powder.

Solubility

:

Insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol.

Identification – A

:

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

Identification – B

:

The Rf value of the principal spot obtained from the test solution corresponds to that obtained from the standard solution.

Specific rotation

:

Between + 63.00 and + 70.000.

Loss on drying

:

Not more than 1.00%.

Residue on ignition

:

Not more than 0.200%.

Chromatographic purity

:

Any Individual impurity should not more than 1.00%.
: Total impurities should not more than 2.00%.

Residual solvents

:

Methylene chloride not more than 600.00 ppm.

 

:

Chloroform not more than 60.00 ppm.
  : Ethyl acetate not more than 5000.00 ppm.

 

:

Acetone not more than 5000.00 ppm.
  : Methanol not more than 3000.00 ppm.

 

:

Pyridine not more than 200.00 ppm

Assay

:

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

*In-house tests

:

(As per customer requirement)

*Identification

:

The test chromatogram obtained in assay corresponds to the standard chromatogram.

*Particle size

:

90.00% less than 10 micron.

 

:

99.00% less than 50 micron.

*APHA Number

:

Not more than 20.00

*Microbial limit test

:

Total bacterial counts not more than 100 CFU/gm.

 

:

Total fungal counts should be nil.

 

:

Absence of E. coli, P. aeruginosa, S. aureus, Salmonella sp.

End of specification