Macrolides Antibiotics

Test

Specification

Characters

:

White, crystalline powder. Is should be odourless or practically odourless, and should practically tasteless.

Solubility

:

Soluble in alcohol, in acetone and in chloroform; Practically insoluble in water.

Identification      (By IR)

:

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

Crystallinity

:

Meets the requirements.

Water Content

:

Not more than 4.00%w/w.

Free Erythromycin ( By TLC )

:

Not More Than 3.00%w/w.

Residual solvents

:

Acetone: Not more than 5000.00 ppm.

Assay

:

Equivalent to not less than 600 mcg of Erythromycin (C37H67NO13 ) per mg, calculated on anhydrous basis.

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%.

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%.

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

Residual Solvents

:

Acetone: Not more than 5000.00ppm.

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.