API TESTING SPECIFICATION

Name: Erythromycin Ethyl Succinate BP.

T.S.No.: SPEC/API/HEES-007/B/01
Issue Date:01/03/2006

Code: HEES

CAS: 41342-53-4

Storage: In an airtight container, protected from light.

Supersede: SPEC/API/HEES-007/B
Date: 01/04/2002

M.F.:  C43 H75 NO16

M.W.:862.00g/mole

 


Test

 

Specification

Appearance

:

White crystalline powder; hygroscopic.

Solubility

:

Practically insoluble in water; freely soluble in acetone, in ethanol and in methanol.

Identification

:

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

Specific Optical Rotation

:

-70.000 to -82.000

Related Substances

:

Any impurity :NMT 3.00% 

Total impurity NMT 5.00%

Free erythromycin

:

Not more than 6.00%

Water Content

:

Not more than 3.00%.

Sulphated Ash

:

Not More Than 0.300%w/w.

Assay

:

Sum of erythromycin A, erythromycin B and erythromycin C: Minimum 78.00 % (anhydrous substance).
Erythromycin-B: Maximum 5.00%

Erythromycin-C: Maximum 5.00%.

End of specification