3rd generation Antidiabetic drug

Parameters Results
Name Glimepiride
Quality BP/EP/USP
IUPAC Name 3-ethyl-4-methyl-N-(4-[N-((1r,4r)-4-methylcyclohexylcarbamoyl)sulfamoyl]phenethyl)-2-oxo-2,5-dihydro-1H-pyrrole-1-carboxamide
Molecular Formula C24H34N4O5S
Molecular Weight 490.617 gm/mol
CAS Number 93479-97-1
Physical Appearance A white or almost white crystalline powder
Solubility Practically insoluble in water, soluble in Dimethylformamide, slightly soluble in Methylene Chloride, very slightly soluble in Methanol
Appearance of Solution 5% solution is clear and not more intensely colored than reference solution BY7
Identification by IR Absorption The absorption maxima in the spectrum obtained with the sample should correspond in position and relative intensity to those in the spectrum obtained with that of standard.
Relative Impurities
Impurity A
Impurity B
Impurity D
Unspecified Impurity
Total Impurity

Not more than 0.8%
Not more than 0.4%
Not more than 0.2%
Not more than 0.1%
Not more than 0.5%
Water (by K.F.) Not more than 0.5% w/w
Sulphated Ash Not more than 0.1% w/w
Residual Solvent

Not more than 3000 ppm
Not more than 5000 ppm
Assay (on dry basis) 97% to 102% as C24H34N4O5S