API TESTING SPECIFICATION

Name: Erythromycin BP.

T.S.No.: SPEC/API/HEB-004/B/01
Issue Date: 01/03/2006

Code: HEB

CAS: 114-07-8

Storage: Protected from light.

Supersede: SPEC/API/HEB-004/B
Date: 01/04/2002

M.F.:  C37 H67 NO13

M.W.: 734.00 g/mole

 


Test

 

Specification

Description

:

White or slightly yellow powder or colourless or slightly yellow crystals, slightly hygroscopic.

Solubility

:

Slightly soluble in water (the solubility decreases as the temperature rises), freely soluble in alcohol, soluble in methanol.

Identification

:

(Test-A or tests-B, C, & D)

Identification - A

:

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

Identification – B    (By TLC)

:

The principal spot in the chromatogram obtained with test solution is similar in position, colour and size to the principal spot in the    chromatogram obtained with reference solution (a) and its position and colour are different from those of the spots in the chromatogram obtained with reference solution (b).

Identification – C    

:

A red colour should develop.

Identification – D

:

A yellow colour should develop.

Specific Optical Rotation

:

-71.00° to -78.00°

Related substances

:

Any individual impurity : NMT 3.00 % 
Total  impurities : NMT 7.00 %           

Test

 

Specification

Thiocyanate

:

Maximum 0.30 %.

Water

:

Maximum 6.50 %.

Sulphated ash

:

Maximum 0.200%

Assay

:

The sum of Erythromycin A, Erythromycin B and Erythromycin C should not be less than 93.00%w/w and not more than 102.00% (anhydrous substance).
Erythromycin-B: Maximum 5.00%
Erythromycin-C: Maximum 5.00%

End of specification