米格列醇

Almost white to yellowish Crystalline powder

M.P:142.0~146.0℃

Identification: color reaction,the color of pale blue to purple develops; 

HPLC,the retention time of principal peak should comply with its CRS.

Specific rotation: -6°~-9°

Single impurity: ≤0.5%

Total impurities: ≤1.0%

Methanol: ≤0.2%

Ethanol: ≤0.3%

Chloride ≤0.02%

Loss on drying ≤4.0%

Sulphated ash ≤0.1%

Heavy metals ≤20ppm

Arsenic ≤20ppm

Assay(dried basis) ≥98.5%