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