Product Name

Glimepiride

Batch No

20110701

Produce Date

2011 07 07

Report Date

2011 07 09

Packing Standard

20kg/drum

Quantity

20kg

Ref Standard

USP29 Standard

Retest Date

2013 07 07

Results Of Analysis Tests

Test Item

Analysis Specification

Result

Description

White to off white power

white power

Identification

IR (similar to standard)

Conforms

Related substances by HPLC

Impurity A(Cis-isomer)

≤0.8%

0.13%

Impurity B

≤0.4%

0.16%

Impurity C

≤0.1%

0.05%

Impurity D

≤0.2%

0.11%

Any other impurity

≤0.1%

0.08%

Total impurity

≤0.5%

0.23%

Heavy metals

≤10ppm

<10ppm

Loss on drying

≤0.5%

0.19%

Sulphated ash

≤0.1%

0.07%

Assay(HPLC)

98.0%~102.0%

99.59%

Residual solvents

To comply the test as pre USP<467>

Complies

Conclusion

The results Conform with USP29 Standard