Product:       Nalidixic Acid      C₁₂H₁₂N₂ O₃

Test

Limits

 Description

Solubility

Identification

Melting point

Absorbance

Related substances TLC

Heavy metals

Loss on drying

 Sulphated ash

 ASSAY

A white or pale yellow, crystalline powder.

Practically insoluble in water, soluble in methylene chloride, slightly soluble in acetone and in alcohol. It dissolves in dilute solutions of alkali hydroxides.

A.       UV max at 258nm and 334nm, absorption ratio at 258/334 nm is 2.2 to 2.4.

B.       Infrared spectrophotometry as same as Nalidixic acid CRS

C.       TLC RF value of test and Nalidixic acid CRS are the same.

D.       An orange-red color develops.

225°C - 231°C.

 3% solution at 420 nm is not greater than 0.10-absorbance unit.

The area of any spot apart from the principle peak is not grater than 0.04%, the sum of such spot not grater than 0.1%.

Not more than 20 ppm.

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