Sr No.

Parameter

Specification

1

Description

Off white to dark brown color powder

2

Identification By HPLC

The retention time of the major peak in the chromatogram of sample solution corresponds to that in the chromatogram of standard solution as obtained in Chromatographic purity by HPLC.

3

Water Content by KF(w/w)

Not more than 2.0%

4

Chromatographic Purity by HPLC ( % area)

Not less than 96.0

5

Single Maximum Impurity by HPLC

Not more than 2.0

6

Total impurities by HPLC

Not more than 4.0