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Home » Products » Pharmaceutical Ingredients » Gabapentin

Gabapentin

Gabapentin
Gabapentin
Product Code : MAPS 02
Brand Name : MAPS LABORATORIES
Product Description

Owing to our rich industry experience, we are to offer Gabapentin as the manufacturers and exporters in the market. Our range of products are highly appreciated and praised in the industry because of its optimum quality and superior shelf life. Also, these products are tested on various defined parameters so as to assure its quality. Moreover, this Gabapentin is used for the treatment of neuropathic pain. Furthermore, all these products are being offered at industry competitive prices and in a timely manner.

Features:

  • High medicinal value
  • Safe to use
  • Very reliable
  • Quality approved

Specification :

Tests

Specification

Description

White to off white crystalline powder.

Solubility

Freely Soluble in Water, in alkaline and acidic solution

Identification


Test A

I. R. Absorption spectrum of the sample in potassium bromide dispresion exhibits maxima only at the same
Wave lengths as that of Gabapentin WRS.

Test B

The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in chromatogram of standard preparation as obtained in assay.

Water content [by RE)

Not more than 0.5% w/w

pH

Between 6.5 to 8.0

Residue on ignition

Not more than 0.1% w/w

Hem Metals

Not more than 20 ppm

Assay (on anhydrous basis) & early eluting impurities (by HPLC)


Assay (on anhydrous basis)

Not less than 98.0% w/w and not more than 102.% w/w

Method I
Early eluting impurities)


Gabapentin Related Compound- A

Not more than 0.10% w/w

Gabapentin Related Compound- B

Not more than 0.06% w/w

Gabapentin Related Compound- E

Not more than 0.10% w/w

Individual unknown impurity

Not more than 0.10% w/w

Method II
[Late eluting impurities) By HP LC


Gabapentin Related Compound- D

Not more than 0.10% w/w

Individual unknown impurity

Not more than 0.10% w/w

Total Related Compounds (Including Early eluting impurities)

Not more than 0.50% w/w

Residual Solvents :

(i) Methanol

Not more than 3000 ppm

(ii) Acetone

Not more than 5000 ppm

(iii) Dichloromethane

Not more than 600 ppm

Packing : Double layer polyethylene 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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