Trimetazidine Hydrochloride - White Crystalline Powder, Safe Usage And Quality Checked

Tests

Specification

Description

A white or almost white, crystalline powder.

Solubility

Freely soluble in water, sparingly soluble in ethanol (95%)

Identification by

A) Infrared absorption Spectrophotometry

IR absorption spectrum of the sample in potassium bromide dispersion is concordant with similarly recorded spectrum of Trimetazidine dihydrochloride WS or with the reference spectrum of Trimetazidine dihydrochloride.

B) Gives reaction (a) for chlorides

Complies

Appearance of solution (10 % w/v solution in water)

Clear and not more intensely coloured than reference solution BYS6.

Related substances b HP LC

Trimetazidine impurity A

Not more than 0.1 %

Trimetazidine impurity B

Not more than 0.1 %

Trimetazidine impurity C

Not more than 0.1 %

Trimetazidine impurity D

Not more than 0.1 %

Trimetazidine impurity E

Not more than 0.1 %

Trimetazidine impurity F

Not more than 0.1 %

Trimetazidine impurity H

Not more than 0.1 %

Trimetazidine impurity I

Not more than 0.1 %

Any other impurity

Not more than 0.1 %

Total impurities

Not more than 0.2 %

Impurity G

Not more than 0.1 %

Heavy Metals

Not more than 20 ppm

Sulphated ash

Not more than 0.1 % w/w

Loss on drying

Not more than 2.5 % w/w

Assay by Titrimetry (on dried basis)

Not less than 98.5 and Not more than 101.5 % w/w

Residual Solvents

2- Propanol
Acetone
Methanol

Not more than 5000 ppm
Not more than 5000 ppm
Not more than 3000 ppm