Appearance A white or almost white hygroscopic powder
Solubility Freely soluble in water, slightly soluble in ethanol(96%),practally insoluble in acetone trichlormathane or diethyl ether
Identification Confirms to EP7.0 specification
Acidity or alkalinity 4.0-6.0
Specific optical rotation -63º~-73º
Related Total impurities ≤23.0%
Any impurity ≤4.0%
Impurity 1 ≤3.0%
Impurity 2 ≤4.0%
Impurity 3 ≤3.0%
Impurity 4 ≤3.0%
Impurity 5 ≤3.0%
Impurity 6 ≤4.0
Sulphate 16%-18%
Loss on drying 3.5% max
Sulphated ash 1.0% max
Assay(Dry Basis HPLC) Sum assay: 77%min
E3: 10%max
E1-I: 10%max
E1-7MOA: 10%max
Potency(Moisture bases) ----
Potency(dried bases) ≥19000u/mg