Pregabalin

Pregabalin or (S)-3-(Aminomethyl)-5-methylhexanoic acid is an anticonvulsant, analgesic, and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, opioid withdrawal, and generalized anxiety disorder.

General Properties and Specifications of Pregabalin or (S)-3-(Aminomethyl)-5-methylhexanoic Acid:
Appearance: White to off white powder.
Assay on dried basis: Between 98% and 102%
Identification: By infrared Absorption Spectro Photometry.
Specific optical Rotation: Between +10.0° to +12.0°
Sulfated ash: 0.1% maximum.
Loss on drying: 0.5% maximum.
Heavy metals: 20 ppm maximum.
Related substances:
Single maximum impurity: 0.5% maximum.
Lactum impurity: 0.5% maximum.
Total related impurities: 1% maximum.
Enantiomeric purity by HPLC (R-Pregabalin): 0.5% maximum.
Melting Point: 176C to 178C literature.
Solubility: Sparingly soluble in water.

Pregabalin BP Ph Eur Grade Specifications:
C8H17NO2 --- 159.2 CASC148553-50-8
Action and use: Antiepileptic.

DEFINITION
(3S)-3-(Aminomethyl)-5-methylhexanoic acid.
Content: 98.0 per cent to 102.0 per cent (anhydrous substance).

CHARACTERS
Appearance: White or almost white powder.
Solubility: Sparingly soluble in water, very slightly soluble in methanol, practically insoluble in heptane.

IDENTIFICATION

A. Infrared absorption spectrophotometry.
B. Examine the chromatograms obtained in the test for enantiomeric purity.
Results The principal peak in the chromatogram obtained with the test solution is similar in retention time to the principal peak in the chromatogram obtained with the reference solution.

Enantiomeric purity: To pass the test by Liquid chromatography.
Water: Maximum 0.5 per cent, determined on 0.130 g.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.