Glimepiride - Pharmaceutical Grade White Powder, High Purity Above 97% | Non-toxic, Precise Ph, Effective For Hypersensitivity And Pregnancy

Tests

Specification

Description

A White or almost white powder

Solubility

Soluble in Dimethylformamide
Sparingly soluble in Dichloromethane
Slightly soluble in Methanol
Practically insoluble in water

Identification by Infrared absorption Spectrophotometry

I. R. absorption spectrum of the sample in potassium bromide dispersion is concordant with similarly recorded spectrum of Glimepiride WS or with the reference spectrum of Glimepiride

Related substances by HPLC
Impurity B
Impurity D
Unspecified individual impurity
Total Impurities other than B

Not more than 0.4 %
Not more than 0.2 %
Not more than 0.1 %
Not more than 0.5 %

Impurity A

Not more than 0.8 % of Glimepiride

Sulphated Ash

Not more than 0.2 % w/w

Water

Not more than 0.5 % w/w

Assay by HPLC (On anhydrous basis)

Not less than 97.0 % w/w and
Not more than 102.0 %w/w

Residual solvents Acetone

Not More than 5000 ppm

Packing : Double layer polyethlene bag as primary packing & HDPE drum as secondary packing (5 kg to 25 Kg)