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

M.F.:  C28 H37 FO7

M.W.: 504.6 g/mole







White to cream-white, odorless powder.



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



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

*In-house tests


(As per customer requirement)



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