Product:         Atenolol      C₁₄H₂₂N₂O₃

Test

Limits

 Description

Solubility

Identification

Appearance of 1% solution

Optical rotation

 Related substances HPLC

Chlorides

Loss on drying

Sulphated ash

ASSAY

A white or almost white powder

Sparingly soluble in water, soluble in ethanol, slightly soluble in methylene chloride, practically insoluble in ether.

A. Melting point 152°C to 155°C.

B.  Absorbance ratio 275/282nm 1.15 to 1.20.

C. Infrared spectrophotometry as same as Atenolol CRS

D. TLC RF value of test and Atenolol CRS are the same.

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

+0.10° to -0.10°

The area of any peak apart from the principle peak is not grater than 0.25%, the sum of such

area not grater than 0.5%.

Not more than 0.1 per cent.

Not more than 0.5 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