Acarbose EP used for Diabetes treatment made in China CAS NO.56180-94-0

Appearance

White or yellowish，amorphous powder，hygroscopic.very soluble in water,soluble in methanol，practically insoluble in methylene chloride

Identification 

As per EP7.0

Absorbance 

Max 0.15 at 425nm for solution S

Assay （on anhydrous basis）

95.0%~102.0%

Water 

≤4.0%

Specific optical rotation 

+168°~ +183°

Sulphated ash

≤0.2%

PH

5.5~7.5

Heavy metals

≤20ppm

Related substance

Impurity A≤0.6%

Impurity B≤0.5%

Impurity C≤1.5%

Impurity D≤1.0%

Impurity E≤0.2%

Impurity F≤0.3%

Impurity G≤0.3%

Impurity H≤0.2%

Any other impurities：Each impurities ≤0.2%

Total impurities 

≤3.0%

Total plate count

≤1000cfu/g

Mould 

≤100cfu/g