Anticonvulsant agent

Parameters Results
Name Pregabalin
Quality IP/EP/USP
IUPAC Name (S)-3-(aminomethyl)-5-methylhexanoic acid
Molecular Formula C8H17NO2
Molecular Weight 159.230 gm/mol
CAS Number 148553-50-8
Physical Appearance A White to off white powder
Solubility Sparingly soluble in water
Identification by IR Absorption The infrared absorption spectrum of the sample in potassium bromide dispersion is concordant with similarly recorded spectrum of Pregabalin WS or with the reference spectrum of the Pregabalin
Specific Optical Rotation Between +10.0° to +12.0°
Enantiomeric purity by HPLC (R-Pregabalin) Not more than 0.5% of the area of the S-Pregabalin
Related Substance by HPLC
Lactum Impurity
Single Impurity
Total Impurity

Not more than 0.5%
Not more than 0.5%
Not more than 1.0%
Heavy Metals Not more than 20 ppm
Sulphated Ash Not more than 0.1% w/w
Loss on drying Not more than 0.5% w/w
Assay by HPLC (on dried basis) Between 98.0% to 102.0% w/w