Glimepiride 93479-97-1 CAS NO.93479-97-1

Name: Glimepiride 93479-97-1
SKU: 93479-97-1
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Glimepiride
CAS No.: 93479-97-1
Appearance: white cyrstalline Powder
Assay(HPLC):99.59%

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