Product:        Tamoxifen Citrate  C₂₆H₂₉NO, C₆H₈O₇

Test

Limits

Description

Solubility

Identification

Loss on drying

 Sulphated ash

 ASSAY

A white or almost white, crystalline powder.

It shows polymorphism.

Slightly soluble in water, soluble in methanol, slightly soluble in acetone.

A.       A. UV spectrum shows two absorption maxima, at 237 nm and 275 nm. The absorbance ratio  237/275 nm is 1.45 to 1.65.

B.       Infrared spectrophotometry, as same as Tamoxifen citrate CRS.

C.       TLC RF of test and standard are the same as Tamoxifen citrate CRS

D.       A pink to red color is produced.

E.        E-isomer and related substances HPLC 0.05 per cent.

Not more than 0.5 percent.

Not more than 0.1 percent.

99.0 - 101.0%, 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