API TESTING SPECIFICATION

Name: Erythromycin Estolate USP

T.S.No.: SPEC/API/HEE-006/D/01
Issue Date: 01/03/2006

Code: HEE

CAS: 3521-62-8

Storage: Preserve in tight containers.

Supersede: SPEC/API/HEE-006/D
Date: 01/04/2002

M.F.:  C40 H71 NO14. C12 H26 O4 S

M.W.: 1056.39g/mole

 


Test

 

Specification

Characters

:

White, crystalline powder. Is should be odourless or practically odourless, and should practically tasteless.

Solubility

:

Soluble in alcohol, in acetone and in chloroform; Practically insoluble in water.

Identification      (By IR)

:

The Infra red absorption spectrum should concordant with the spectrum obtained from working std of Erythromycin Estolate or with the reference Infra red spectrum graph.

Crystallinity

:

Meets the requirements.

Water Content

:

Not more than 4.00%w/w.

Free Erythromycin ( By TLC )

:

Not More Than 3.00%w/w.

Residual solvents

:

Acetone: Not more than 5000.00 ppm.

Methylene chloride: Not more than 600.00 ppm.

Assay

:

Equivalent to not less than 600 mcg of Erythromycin (C37H67NO13 ) per mg, calculated on anhydrous basis.

End of specification