PRODUCT CATALOG
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Glimepiride
Human API
Characterised impurities
| Impurity | Chemical name | Pharmacopoeia |
|---|---|---|
| Impurity “A” | 1-[[4-[2-[[(3-ethyl-4- methyl-2-oxo-2,3- dihydro-1H-pyrrol-1- yl)carbonyl]amino]et hyl]phenyl]sulphony l]-3-(cis-4- methylcyclohexyl) urea | BP/EP |
| Impurity “B” | 3-ethyl-4-methyl-2- oxo-N-[2-(4- sulphamoylphenyl) ethyl]-2,3-dihydro- 1H-pyrrole-1- carboxamide | BP/EP/ USP |
| Impurity “C” | Methyl[[4-[2-[[(3- ethyl-4-methyl-2- oxo-2,3-dihydro-1H- pyrrol-1- yl)carbonyl]amino]et hyl]phenyl] sulphonyl] carbamate | BP/EP/ USP |
| “MPR-I” “MPR-II” | 3-Ethyl-2,5-dihydro- 4-methyl-N-(2- phenylethyl)-2-oxo- 1H-pyrrole-1- carboxamide 3-Ethyl-2,5-dihydro- 4-methyl-2-oxo-n-(2- phenyl ethyl)-1h- | IHT IHT |
| “MPR-III” | pyrrole-1- carboxamide (Ethyl(4-(2-(((3-ethyl- 4-methyl-2-oxo-2,5- dihydro-1H-pyrrol-1- yl)carbonyl)amino)et hyl)phenyl)sulfonyl carbamate) | IHT |
| PTA | p-Toluene sulfonamide, 4- methylbenzenesulfo namide | IHT |
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