Product:        Danazol        C₂₂H₂₇NO₂

Test

Limits

 Identification

Melting point

Chromatographic purity

 Specific Rotation

 Organic volatile impurity

 Loss on drying

ASSAY

 A.       UV spectrum as same as Danazol CRS

B.       Infrared spectrophotometry, as same as Danazol CRS.

 About 225°C

 Any other spot other than main spot not more intensely than 0.5% and the sum spot other than main spot not more than 1.0%.

+21° to +27°

Meets the requirements.

Not more than 2.0 per cent.

97.0 –102.0% 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