Details:
Appearance White or pale yellow amorphous powder
Solubility Practical insoluble in water,very soluble in ethanol(96%),slightly soluble in hexane
Identification Conforms
Appearance of solution Clear,color ≤GY5
Related Substances Method A Impurity A ≤1.5%
Impurity B ≤0.5%
Impurity C ≤1.5%
Impurity D ≤2.5%
Impurity E+F ≤1.7%
Impurity G ≤1.5%
Impurity L ≤0.5%
Any other individual impurity before impurity G ≤0.5%
Method B Impurity H+I ≤1.0%
Impurity J ≤0.5%
Impurity K ≤0.5%
Any other individual impurity after impurity G ≤0.5%
Total impurity ≤7.0%
Heavy metals ≤ 20ppm
Water ≤ 1.3%
Sulphated Ash ≤0.2%
Assay(on the anhydrous basis) 92.0%~~102.0%
Antioxidant Assay 0.3%~~0.6%
Residual
Solvents Methanol ≤3000ppm
Ethanol ≤5000ppm
Dichloromethane ≤600ppm
Propenol ≤50ppm
Triethylamine ≤320ppm
N-Heptane ≤5000ppm
Methylcyclohexane ≤1180ppm
1,4-Dioxane ≤380
Butyl Ac3tate ≤5000ppm
Dinethyl Sulfixide ≤5000ppm