Parameter

Specification

Description

White to Off white colored powder

Identification by IR

To match with standard

Identification By HPLC

The retention time of test sample should match with that of retention time of standard in Assay by HPLC Test

Water Content by KF(w/w)

Not more than 0.30% w/w

Residue On Ignition

Not more than 0.50% w/w

Related Substances By HPLC (%)

i) 3-Iodo-2-Methylbenzoic Acid : NMT 0.20%
ii)3,5-Diiodo Impurity : NMT 0.30%
iii) Single Maximum unknown impurity: NMT 0.10%
iv) Total Impurities : NMT 1.0%

Assay By HPLC on Anhydrous basis (%w/w)

Not Less than 97.0%