Items

Specifications

Results

Appearance

A white or almost white powder

Conforms

Solubility

Soluble in water and in ethanol (96%)

Conforms

Identification

A

Melting point : 163°C~166°C

164.0~164.5°C

B

Examine by infrared absorption spectrophotometry, comparing with the spectrum obtained with propranolol hydrochloride CRS.

Conforms

C

Examine by thin-layer chromatography. The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution.

Conforms

D

It gives reaction(a) of chlorides

Conforms

Tests

Appearance of solution

The solution is clear and not more intensely coloured than intensity 6 of the range of reference solutions of the most appropriate colour

Conforms

Acidity or alkalinity

Add 0.1ml of methyl red solution R and 0.2 ml of 0.01M hydrochloric acid, the solution is red. Add 0.4ml of 0.01 M sodium hydroxide. The solution is yellow.

Conforms

Related substances

Any impurity NMT 0.1%

0.03%

The sum of all impurities NMT 0.4%

0.21%

Heavy metals

NMT 20ppm

Conforms

Loss on drying

NMT 0.5%

0.11%

Sulphated ash

NMT 0.1%

0.08%

Residual solvents

A: ethanol: NMT 5000ppm

B: Xylene: NMT 2170ppm

Conforms

Conforms

Assay

99.0%~101.0%

99.3%

Conclusion: conform to EP7.0