Appearance
White or light yellow powder
Source
Semi-synthetic
Impurity Profile
Impurity G: Not more than 2.0%
Impurity E: Not more than 0.7%
Impurity H: Not more than 0.5%
Impurity I: Not more than 0.5%
Any other impurity: Not more than 0.2%
Total impurities: Not more than 3.5%
Assay
(A3 + A4): 95.0 - 102.0%
A3 Ratio: Not more than 0.20
A4 Ratio: Not less than 0.80
Residual Solvents
Ethanol: Not more than 5000 ppm
Acetone: Not more than 5000 ppm
n-Heptane: Not more than 5000 ppm
Methanol: Not more than 3000 ppm
4-Dioxane: Not more than 380 ppm
Methylene chloride: Not more than 600 ppm
Chloroform: Not more than 60 ppm
