Offering Esomeprazole Magnesium Powder:

TEST

SPECIFICATION

Description

An off white to cream color crystalline powder

Solubility

Soluble in Dimethyl formamide, sparingly soluble in methanol.

Identification by IR

The infra red absorption spectrum of the finely ground sample in KBr dispersion compressed into a disc should exhibit maxima only at the same wavelengths as that of a similar preparation of Esomeprazole magnesium trihydrate working standard.

Water content

Between 6.0 to 10.0%w/w

Heavy metals

NMT 10 ppm

Specific optical rotation

Between -128.5º and -140.5º

Magnesium content

Between 3.0% and 4.0%

Related substances

By HPLC

Maximum single impurity

Total impurities

NMT 0.5%

NMT1.0%

Assay by HPLC (on anhydrous basis)

Between 98.0% and 102.0%w/w