API TESTING SPECIFICATION

Name: Erythromycin Stearate BP.

T.S.No.:SPEC/API/HES-005/B/01
Issue Date: 01/03/2006

Code: HES

CAS: 1643-22-1

Storage:

Supersede: SPEC/API/HES-005/B
Date: 01/04/2002

M.F.:  C55 H103 NO15

M.W.:1018.00 g/mole

 

Test

 

Specification

Description

:

White, crystalline powder.

Solubility

:

Practically insoluble in water, soluble in acetone and in methanol. Solutions may be opalescent.

Identification - A

:

The Infra-red absorption spectrum should be concordant with the reference spectrum of Erythromycin stearate CRS.

Identification – B    (By TLC)

:

The chromatogram obtained with test solution should show 2 spots, one of which should correspond in position to the principal spot in the    chromatogram obtained with reference solution (a) and the other to the principal spot in the chromatogram obtained with reference solution (b).

Free Stearic Acid

:

Maximum 14.00%.

Related substances

:

Any individual impurity : NMT 3.00 % 

Total  impurities : NMT 6.00 %

Water

:

Maximum 4.00%.

Sulphated Ash

:

Maximum 0.500%.

Assay

:

Sum of the contents of erythromycin A, erythromycin B and erythromycin C: minimum 60.50 % (anhydrous substance).
Erythromycin-B: Maximum 5.00%

Erythromycin-B: Maximum 5.00%

End of specification