Pregabalin - White To Off White Powder, Precise Composition | Best Quality, Highly Demanded In Medical Sectors

Tests

Specification

Description

White to off white powder

Solubility

Sparingly soluble in water, slightly soluble in methanol.

Identification by IR

Determine by infrared absorption spectrophotometry. Compare the spectrum with that obtained with pregabalin RS or with the reference spectrum of pregabalin.

Specific Optical Rotation (C = 1% w / V in water)

Between +10.0^o to +12.0^o

Enantiomeric purity

R-Pregabalin: NMT 0.5 % the area of S-Pregabalin

Related Substance by HPLC

Single Max. Imp. : NMT 0.5 %W/w
Total Impurities : NMT 1.0 %w/w

Heavy metals

Not more than 20 ppm

Sulphated ash

Not more than 0.10 % W/w

Loss on drying

Not more than 0.5 % W/w

Assay by HPLC

Not less than 98.0 % w/w and Not more than 102.0 % w/w

Residual Solvent:

Methanol
N- Butanol
Ethyl acetate
Chlorofornl
Toluene

NMT 3000 ppm
NMT 5000 ppm
NMT 5000 ppm
NMT 60 ppm
NMT 890 ppm

Packing : Double layer polyethlene bag as primary packing & HDPE drum as secondary packing (5 kg to 25 Kg)