Product:         Lidocaine Base      C₁₄H₂₂N₂O

Test

Limits

 Description

Solubility

Identification

Appearance of 10%solution

2,6-Dimethylaniline

 Chlorides

 Sulphates

 Heavy metals

 Water

 Sulphated ash

 ASSAY

A white or almost white, crystalline powder

 Practically insoluble in water, very soluble in alcohol and in methylene chloride, freely soluble in ether.

A.       Melting point: 66°C to 70°C

B.       Infrared spectrophtometry as same as lidocaine base CRS 

C.       Dried precipitate melts at about 230°C, with decomposition.

 D.   A green color is produced.

 E.   A bluish-green precipitate is formed.

Is clear and colorless.

Not more than 100 ppm.

Not more than 35 ppm.

Not more than 0.1 per cent.

Not more than 20 ppm.

Not more than 1.0 per cent.

Not more than 0.1 per cent.

99.0 - 101.0 % w/w calculated with reference to the dried substance.

This material has been prepared following the good manufacturing practice (G.M.P.) and conforms above specification & requirements of BP2000