Product:       Mebendazole    C₁₆H₁₃N₃O₃

Test

Limits

 Description

Solubility

Identification

Related substances TLC

Heavy metals

Loss on drying

 Sulphated ash

 ASSAY

A white TO slightly yellow powder.

It shows polymorphism.

Practically insoluble in water, in alcohol, in ether and in methylene chloride.

A. UV absorption maximum, at 247 nm and 312 nm, the specific absorbances at these maximum are 940 to 1040 and 485 to 535, respectively.

B. Infrared spectrophotometry as same as Mebendazol CRS.

C. An intense yellow color is produced.

Any other spot other than main spot not more intensely than 0.25% and the sum spot other than main spot not more than 0.5%.

Not more than 20 ppm.

Not more than 0.5 percent

Not more than 0.1 percent.

98.0 - 102.0 % 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