API TESTING SPECIFICATION

Name: Erythromycin Estolate BP.

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

Code: HEE

CAS: 3521-62-8

Storage: Protected from light.

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

M.F.:  C40 H71 NO14, C12 H26 O4 S

M.W.:1056.00g/mole

 


Test

 

Specification

Description

:

White or almost white, crystalline powder.

Solubility

:

Practically insoluble in water, freely soluble in ethanol (96 percent), soluble in acetone. It should practically insoluble in dilute hydrochloric acid.

Identification

:

The Infra-red absorption spectrum should be concordant with the reference spectrum of erythromycin Estolate CRS.

Related substances

:

Impurities A, B, C, D, E, F, G: NMT 3.00% (For each impurity)
Any other impurity : NMT 0.20 % 

Total  impurities : NMT 5.00 %

Free erythromycin

:

Not more than 6.00%.

Dodecyl Sulphate

:

23.00% to 25.50% of C12H26O4S (anhydrous substance).

Water

:

Maximum 4.00%.

Sulphated Ash

:

Maximum 0.500%.

Assay

:

86.00% to 102.00% (anhydrous substance).
Erythromycin-B: Maximum 5.00%

Erythromycin-C: Maximum 5.00%

End of specification