Parameter

Specification

Description

White to yellowish coloured powder.

Identification by IR

Infrared spectrum of the test exhibit intense peak at 1530, 1351, 1160 and 605cm^-1 (±5cm^-1) as that of standard, obtained in the same manner.

Identification By HPLC

The retention time of the major peak in the chromatogram of the test preparation corresponds to that in the chromatogram of the standard preparation as obtained under assay by HPLC.

Loss on Drying

Not more than 7.0% w/w

Assay by HPLC (on dried basis)

Between 98.0% to 103.0%

Enantiomeric purity by HPLC

Isomer I : Not more than 0.1%

Isomer II : Not more than 0.1%

Isomer III : Not more than 0.1%

Related Substances By HPLC (%)

DNV-I : Not more than 0.5%

Impurity at RRT about 1.24 : Not more than 0.5%

Any other individual impurity : Not more than 0.1%

Total impurity : Not more than 1.0%