API TESTING SPECIFICATION

Name: Erythromycin Stearate USP

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

Code: HES

CAS: 643-22-1

Storage: Preserve in tight containers.

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

M.F.:  C37 H67 NO13. C18 H36 O2

M.W.: 1018.40g/mole

 

Test

 

Specification

Characters

:

White or slightly yellow crystals or powder. It should odourless or may have a slight, earthy odor, and has a slight bitter taste.

Solubility

:

Practically insoluble in water; soluble in alcohol, in chloroform, in methanol, and in ether.

Identification      (By IR)

:

The IR absorption spectrum of the sample should exhibit maxima only at the same wavelengths as that of a similarly preparation of working standard of Erythromycin stearate.

Crystallinity

:

Meets the requirements

Water Content

:

Not more than 4.00%w/w.

Residue on Ignition

:

Not More Than 1.000%w/w.

Related compounds

:

Pseudoerythromycin A enol ether should not be more than 3.00%w/w,
Erythromycin A enol ether should not be more than 3.00%w/w, and

Any  individual related compound should not be more than 3.00%w/w.

Residual Solvents

:

Acetone: Not more than 5000.00ppm.

Methylene chloride: Not more than 600.00ppm.

Assay

:

The sum of the percentages of Erythromycin A, Erythromycin B and Erythromycin C should not be less than 55.00%w/w , calculated on anhydrous basis.

End of specification