API TESTING SPECIFICATION

Name: Beclomethasone Dipropionate USP

T.S.No.: SPEC/API/HBMD-011/D/01
Issue Date: 01/03/2006

Code: HBMD

CAS: 5534-09-8

Storage: Preserve in well-closed containers.

Supersede: SPEC/API/HBMD-011/D
Date: 01/04/2002

M.F.:  C28 H37 CIO7

M.W.: 521.04 g/mole

 

Test

 

Specification

Description

:

White to cream-white, odorless powder.

Solubility

:

Very Slightly soluble in water; very soluble in chloroform; freely soluble in acetone and in alcohol.

Identification – A

:

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

Specific rotation

:

Between + 88.00 and + 94.000.

Loss on drying

:

Not more than 0.50%.

Residue on ignition

:

Not more than 0.100%.

Residual solvents

:

Acetone not more than 5000.00 ppm.

 

:

Methylene Chloride not more than 600.00 ppm

 

:

Ethyl acetate not more than 5000.00 ppm.

 

:

Pyridine not more than 200.00 ppm.

 

:

Chloroform not more than 60.00 ppm.

Assay

:

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

*In-house tests

:

(As per customer requirement)

*Microbial limits

:

NMT 100 cfu/g

*Microbial limits

:

Absence of Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella species.

*Particle size

:

90.00% < 10 micron, 99.00% < 50 micron.

End of specification