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Home » Products » Pharmaceutical Ingredients » Pregabalin

Pregabalin

Pregabalin
Pregabalin
Product Code : MAPS 01
Brand Name : MAPS LABORATORIES
Product Description

With such a sound infrastructure and latest technology, we are able to gain a position as the manufacturers and exporters in the industry for Pregabalin. We are having an expert and highly qualified team of professionals who have immense knowledge and expertise about this domain and process the products accordingly. Moreover, this Pregabalin is used for neuropathic pain and add on therapy for partial seizures. Further, these products are being offered at very cost effective prices.

Features:

  • Best quality
  • Completely tested
  • Highly demanded in medical sectors
  • Precise composition

Specification :

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 +10.0o to +12.0o

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)

 


MAPS LABORATORIES PVT. LTD.
Plot no 38, rafaleshwar GIDC 8-A N.H., At. Jambudiya, Morbi - 363642, Gujarat, India
Mr. Rupesh Patel (Director)
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