Lamotrigine By Maps Laboratories Pvt. Ltd.

Tests

Specification

Description

White or almost white Powder

Solubility

Very Slightly Soluble in water, Slightly soluble in anhyrous ethanol

Identification
Infrared absorption Spectroscopy

The I.R. Absorption spectrum of sample should be concordant with the I.R. Spectrum of Lamotrigine WS.

Related substances
Impurity A
Impurity G
Impurity F
Unspecified Impurities
Total Impurities

Not more than 0.1 %
Not more than 0.1 %
Not more than 0.2 %
Not more than 0.10 %
Not more than 0.2 %

Impurity E

Not more than 0.1 %

Heavy Metals

Not more than 10 ppm

Loss on Drying

Not more than 0.5 % w/w

Sulphated ash

Not more than 0.1 % w/w

Assay by HPLC (On anhydrous basis)

Not less than 99.0 % w/w and
Not More Than 101.0 %w/w

Residual Solvents :
Toluene
Methanol

Not more than 3000 ppm
Not more than 5000 m