Test |
|
Specification |
Characters |
: |
A white or slightly yellow, crystalline powder.It should odorless or practically odorless. |
Solubility |
: |
Slightly soluble in water; soluble in alcohol, in chloroform and in ether. |
Identification (By IR) |
: |
The IR absorption spectrum of a solution should exhibit maxima only at the same wavelengths as that of a similarly prepared solution of working standard of Erythromycin, except in the region between 1980 cm-1 and 2050cm-1 |
Specific rotation |
: |
Between - 71.00° to - 78.00°. |
Crystallinity |
: |
Meets the requirement. |
Water Content |
: |
Not more than 10.00%w/w. |
Residue On Ignition |
: |
Not More Than 0.200%w/w. |
Limits of Thiocyanate |
: |
Not More Than 0.30%w/w. |
Limit of Related Substances
( By HPLC ) |
: |
Erythromycin B should not be more than 12.00%w/w,
Erythromycin C should not be more than 5.00%w/w,
Erythromycin A enol ether should not be more than 3.00%w/w, and
Any other individual impurity 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 85.00%w/w and not more than 100.50%, calculated on anhydrous basis. |
End of specification |