API TESTING SPECIFICATION

Name: Betamethasone USP

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

Code: HBMS

CAS: 378-44-9

Storage: Preserve in tight containers. Store between 20C and 300C.

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

M.F.:  C22 H29 FO5

M.W.: 392.46g/mole

 

Test

 

Specification

Characters

:

White to practically white, odourless, crystalline powder. It should melt at about 240.00C, with some decomposition.

Solubility

:

Insoluble in water; sparingly soluble in acetone, in alcohol, in dioxin, and in methanol; very slightly soluble in chloroform and in ether.

Identification A     (By IR)

:

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

Identification B     (By TLC)

:

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

Specific rotation

:

Between + 118.000 to + 126.000 on dried basis.

Loss on drying

:

Not more than 1.00%w/w.

Residue on Ignition

:

Not more than 0.200%w/w.

Ordinary Impurity  ( By TLC )

:

Not More than 2.00%.

Residual solvents

:

Meets the requirements.

Assay

:

97.00 % to 103.00% w/w, on dried basis.

End of specification