API TESTING SPECIFICATION

Name: Erythromycin Ethylsuccinate USP

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

Code:HEES

CAS: 1264-62-6

Storage: Preserve in tight containers.

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

M.F.:  C43 H75 NO16

M.W.: 862.05g/mole

 


Test

 

Specification

Characters

:

White or slightly yellow crystalline powder. Is should be odorless or practically odorless, and should practically tasteless.

Solubility

:

Very slightly soluble in water; freely soluble in alcohol, in chloroform and in polyethylene glycol 400.

Identification      (By IR)

:

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

Crystallinity

:

Meets the requirements, except that when it is labeled as being in the amorphous state is does not meet the requirement.

X ray diffraction

:

Where labeled as being in the amorphous state in the x ray diffraction state performed at high sensitivity for angles of diffraction between 20 and 200 exhibits no reflection, and between 70 and 100 exhibits a more intense hachured baseline, creation a halo.

Water Content

:

Not more than 3.00%w/w.

Residue on Ignition

:

Not More Than 1.00%w/w.

Related Compounds

:

Any individual compound should not be more than 3.00%.
Erythromycin-A enol ether should not be more than 3.00%.

Erythromycin N- ethylsuccinate should not be more than 3.00%.

Residual solvents

:

Acetone: Not more than 5000.00 ppm.

Methylene Chloride: Not more than 600.00 ppm.

Assay

:

Sum of Erythromycin A, Erythromycin B and Erythromycin C is not less than 76.5% calculated on the anhydrous basis. The percentage of Erythromycin B should not more than 12.00% and the percentage Erythromycin C should not more than 5.00%.

End of specification