Test |
|
Specification |
Appearance |
: |
White crystalline powder; hygroscopic. |
Solubility |
: |
Practically insoluble in water; freely soluble in acetone, in ethanol and in methanol. |
Identification |
: |
The Infra-red absorption spectrum should be concordant with the reference spectrum of Erythromycin Ethyl Succinate CRS. |
Specific Optical Rotation |
: |
-70.000 to -82.000 |
Related Substances |
: |
Any impurity :NMT 3.00%
Total impurity NMT 5.00% |
Free erythromycin |
: |
Not more than 6.00% |
Water Content |
: |
Not more than 3.00%. |
Sulphated Ash |
: |
Not More Than 0.300%w/w. |
Assay |
: |
Sum of erythromycin A, erythromycin B and erythromycin C: Minimum 78.00 % (anhydrous substance).
Erythromycin-B: Maximum 5.00%
Erythromycin-C: Maximum 5.00%. |
End of specification |