API TESTING SPECIFICATION

Name: Betamethasone Sodium Phosphate USP

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

Code: HBSP

CAS: 151-73-5

Storage: Preserve in tight containers.

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

M.F.:  C22 H28 FNa2 O8 P

M.W.: 516.40g/mole

 


Test

 

Specification

Characters

:

White to practically white, odourless powder.It should hygroscopic.

Solubility

:

Freely soluble in water and in methanol; practically insoluble in acetone and in chloroform.

Identification A     (By IR)

:

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

Identification B     (By TLC)

:

The Rf value of the principal spot in the chromatogram obtained from test solution should correspond to that obtained from working standard solution of Betamethasone sodium phosphate.

Identification C     

:

Residue of test sample should give the reaction of sodium salts and phosphates.

Specific Rotation

:

+ 99.000 to + 105.000 on anhydrous basis.

Water Content

:

Not more than 10.00%w/w.

Limit of phosphate ions ( By UV )

:

Not more than 1.00%w/w.

Limit of Free Betamethasone     ( By UV )

:

Not more than 1.00%w/w.

Residual solvents

:

Acetone not more than 5000.00 ppm.

Methanol not more than 3000.00 ppm.

Ethyl acetate not more than 5000.00 ppm.

Tetra hydro furan not more than 720 ppm.

Assay

:

Not less then 97.00 % w/w and not more then 103.00% w/w, on anhydrous basis.

End of specification