Glimepiride 93479-97-1
Product Description
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 |