Gabapentin By Maps Laboratories Pvt. Ltd.

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)