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.
Methylene chloride: Not more than 600.00 ppm. |
Assay |
: |
Equivalent to not less than 600 mcg of Erythromycin (C37H67NO13 ) per mg, calculated on anhydrous basis. |
End of specification |