Glimepiride Glimepride Glimpiride
Glimepiride
1h-pyrrole-1-carboxamide,2,5-dihydro-3-ethyl-4-methyl-n-(2-(4-(((((4-methylcyc; glimepirid; hoe490; trans-lohexyl)amino)carbonyl)amino)sulfonyl)phenyl)ethyl)-2-oxo; 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea; amary; AMARYL; Glimpiride; 4-ethyl-3-methyl-N-[2-[4-[(4-methylcyclohexyl)carbamoylsulfamoyl]phenyl]ethyl]-5-oxo-2H-pyrrole-1-carboxamide; Glimepride
Items |
Standard |
---|---|
Appearance |
White or almost white powder |
Solubility |
Practically insoluble in water; Soluble in dimethylformanide; slightly soluble in methylene chloride, very slightly soluble in methanol. |
Identification IR |
Conforms to glimepiride CRS |
Releated substances Impurity B Impurity C Impurity D Specified unidentified RRT 0.67 RRT 0.83 Unsoecified impurity,each sum of impurities other than B |
Not more than 0.4% Not more than 0.1% Not more than 0.2%
Not more than 0.1% Not more than 0.1% Not more than 0.5% |
Impurity A |
Not more than 0.4% |
Assay (amhydrous substance) |
Not less than 98.0% and not more than 102.0% |
Residual Solvents Acetone |
Not more than 2000ppm |
Particle size distribution D100 D90 |
Not more than 2000um Not more than 2000um |
Glimepiride
1h-pyrrole-1-carboxamide,2,5-dihydro-3-ethyl-4-methyl-n-(2-(4-(((((4-methylcyc; glimepirid; hoe490; trans-lohexyl)amino)carbonyl)amino)sulfonyl)phenyl)ethyl)-2-oxo; 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea; amary; AMARYL; Glimpiride; 4-ethyl-3-methyl-N-[2-[4-[(4-methylcyclohexyl)carbamoylsulfamoyl]phenyl]ethyl]-5-oxo-2H-pyrrole-1-carboxamide; Glimepride
Items |
Standard |
---|---|
Appearance |
White or almost white powder |
Solubility |
Practically insoluble in water; Soluble in dimethylformanide; slightly soluble in methylene chloride, very slightly soluble in methanol. |
Identification IR |
Conforms to glimepiride CRS |
Releated substances Impurity B Impurity C Impurity D Specified unidentified RRT 0.67 RRT 0.83 Unsoecified impurity,each sum of impurities other than B |
Not more than 0.4% Not more than 0.1% Not more than 0.2%
Not more than 0.1% Not more than 0.1% Not more than 0.5% |
Impurity A |
Not more than 0.4% |
Assay (amhydrous substance) |
Not less than 98.0% and not more than 102.0% |
Residual Solvents Acetone |
Not more than 2000ppm |
Particle size distribution D100 D90 |
Not more than 2000um Not more than 2000um |
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