Sr. No

Parameter

Specification

1

Description

White to yellowish crystalline hygroscopic powder

2

Identification by IR

IR spectrum of the test exhibits intense peaks at about 1271,1024 and 960 cm ^-1 (± 5 cm ^-1)

3

Identification by HPLC

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

4

Water content by KF

Not more than 1.0 % w/w

5

Assay By HPLC Method (On anhydrous and solvent-free basis)

Not less than 98.0 % w/w

6

Related Substances by HPLC Method

2-Chloro Oxadiazole impurity

Not more than 0.1%

Hydrazide adduct impurity

Not more than 0.2%

Any Other individual impurity

Not more than 0.1%

Total impurities

Not more than 1.0%

7

Limit of Ethylenediamine by IC Method

Not more than 0.5%

8

Residual Solvents by GC Method

Methanol

Not more than 3000 ppm

Acetonitrile

Not more than 410 ppm

Dichloromethane

Not more than 600 ppm