93479-97-1 Glimepiride 4-ethyl-3-methyl-N-[2-[4-[(4-methylcyclohexyl)carbamoylsulfamoyl]phenyl]ethyl]-5-oxo-2H-pyrrole-1-carboxamide
Product Name | Glimepiride |
Synonyms | AMARYL;3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE;3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXYAMIDE;Gliclazide(diamicron);CLIMEPIRIDE;Glimpiride;3-Ethyl-2,5-dihydro-4-methyl-N-[2-[4-[[[[trans-4-methylcyclohexyl)amino]carbonyl]amino]sulfonyl]phenyl]ethyl]-2-oxo-1H-pyrrole-1-carboxyamide;1H-Pyrrole-1-carboxamide, 3-ethyl-2,5-dihydro-4-methyl-N-2-4-(trans-4-methylcyclohexyl)aminocarbonylaminosulfonylphenylethyl-2-oxo- |
CAS | 93479-97-1 |
MF | C24H34N4O5S |
MW | 490.62 |
EINECS | 999-999-2 |
Product Categories | Active Pharmaceutical Ingredients;APIs;Intermediates & Fine Chemicals;Pharmaceuticals;Monovalent Ion Channels;Potassium Channel Modulators;Voltage-gated Ion Channels;API's;Chiral Reagents;Heterocycles;Sulfur & Selenium Compounds;API;NEURONTIN;Diabetes Research |
Test Item |
Analysis Specification |
Result |
||
Description |
White crystalline powder |
White crystalline powder |
||
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 |
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