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 |