Acarbose

Item

Specifications

Results

Appearance

white or yellowish amorphous powder

Conforms

Identification

A:Infrared Absorption: The IR absorption spectrum of the preparation of the test specimen, exhibits maxima only at the same wavelengths as that of a similar preparation of the corresponding working standard.

Conforms

B:The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

Conforms

Assay

95.0 ~ 102.0% (anhydrous substance)

95.55%

Absorbance

≤0.15(At 425nm)

0.013

Specific optical rotation

+168°~ +183°

+174°

PH

5.5 ~ 7.5

5.7

Sulphate Ash

≤0.2%

0.0%

Water

≤4.0%   

2.12%

Heavy Metals

≤20ppm

<20ppm

Total impurities

≤3.0% 

1.22%

Any impurity

≤0.2%

0.02%

Impurity A

≤0.6%

0.40%

Impurity B

≤0.5%

0.03%

Impurity C

≤1.5%

0.33%

Impurity D

≤1.0%

0.06%

Impurity E

≤0.2%

0.13%

Impurity F

≤0.3%

undetected

Impurity G

≤0.3%

undetected

Impurity H

≤0.2%

undetected

Impurity I

≤0.2%

undetected

Impurity J

≤0.3%

undetected

Microbiological purity

Not more than 1000 aerobic bacteria per 1g

10 cfu /g

Not more than 100 fungi per 1g

<10cfu/g

Absence of Escherichia coli per 1g

undetected

Conclusion

The results conforms with USP 35 standards