Product: Propranolol Hydrochloride  C₁₂H₁₂N₂ O_3, HCl

Test

Limits

 Description

Solubility

Identification

Melting point

Appearance of solution

Acidity or alkalinity

Related substances HPLC

Heavy metals

Loss on drying

 Sulphated ash

Specific rotation

 ASSAY

A white or almost white powder.

Soluble in water and alcohol.

A.       Infrared spectrophotometry as same as Propranolol CRS

B.       TLC RF value of test and Propranolol CRS are the same.

C.       It gives reaction of chlorides

163°C - 166°C.

10% solution Is clear and not more intensely colored than degree 6 of the range of reference solutions of the most appropriate color

To 1% solution Add 0.2 ml of methyl red solution and 0.2 ml of 0.01M hydrochloric acid. The solution is red. Add 0.4 ml of 0.01M sodium hydroxide. The solution is yellow.

The area of any peak apart from the principle peak is not grater than 0.1%, the sum of such area not grater than 0.4%.

Not more than 20 ppm.

Not more than 0.5 per cent.

Not more than 0.1 per cent.

-1.0 to +1.0

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