ITEMS

SPECIFICATIONS

Appearance

White or off white crystal powder, afraid of light

Identity

IR

UV

Forward reaction

IR spectrum concordant with the working reference

Colour of solution

Clear and not darker in colour than matching solution A,B and C

Specific optical rotation

95-105°

Loss on drying

Not more than 4.0%

Residue on igniton

Not more than0.1%

Heavy metals

Not more than0.002%

Content

Methanesulfonic acid

12.5-13.4%

Related substances

Bromocriptinine

Other individual

Total

Not more than0.1%

Not more than0.1%

Not more than0.5%

Residua solvents

Toluene

Ethanol

Acetone

Diethyl ethe

Methanol

1,4-dioxan

Methylene-chloride

Not more than890ppm

Not more than5000ppm

Not more than5000ppm

Not more than5000ppm

Not more than3000ppm

Not more than380ppm

Not more than600ppm

Assay

Recalculated on dried substance

98.0-102.0%