Appearance

White or off-white crystalline Powder

White crystalline powder

Identification

A: Infrared absorption

Complies

B: The retention time of the major peak from the Sample solution corresponds to that of the Standard preparation, as obtained in the Assay.

Complies

Tests

Water

Not more than 0.2%

0.16%

Residue on ignition

Not more than 0.1%

0.08%

Heavy metals

Not more than 10ppm

Complies

Related substances

Des-fluoro analog not more than 0.2%

2-Fluoro isomer not more than 0.2%

Des hydroxy analog not more than 0.2%

Individual unspecified impurity not more than 0.1 %

Total impurity is not more than 0.5%

0.08%

0.09%

0.13%

00

0.3%

Assay

Bicalutamide contains not less than 98.0 percent and not more than 102.0 percent of C18H14F4N2O4S, calculated on the anhydrous and solvent-free basis.

99.7%

Remarks: The material complies with respect to USP34.