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







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



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.



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

End of specification