Product:      Lidocaine Hydrochloride   C₁₄H₂₂N₂O, HCl

Test

Limits

 Description

Solubility

Identification

Appearance of 5% solution

pH

2,6-Dimethylaniline

Heavy metals

 Water

 Sulphated ash

 ASSAY

A white crystalline powder

 Very soluble in water, freely soluble in alcohol, practically insoluble in ether.

A.       Melting point: 74°C to 79°C

B.       Infrared spectrophotometry as same as Lidocaine hydrochloride CRS

C.       Dried precipitate melts at about 230°C.

D.       A green color is produced.

E.        A bluish-green precipitate is formed.

F.        It gives reaction of chlorides.

Is clear and colorless.

4.0 – 5.5

Not more than 100 ppm.

Not more than 5 ppm.

5.5-7.0 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