Product:       Piroxicam    C₁₅H₁₃N₃O₄S

Test

Limits

Description

Solubility

Identification

Appearance of solution

Related  substances HPLC

Heavy metals

Loss on drying

Sulphated ash

ASSAY

A white or slightly yellow, crystalline powder.

It shows polymorphism.

Practically insoluble in water, soluble in methylene chloride, slightly soluble in ethanol.

A.       UV spectrum is as same as Piroxicam CRS.

B.        Infrared spectrophotometry as same as Piroxicam CRS.

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

10% solution is clear and not more intensely colored than intensity 6 of the range of

The area of any peak apart from the principle peak is not grater than 0.2%, 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.

98.5 - 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