Item

Specification

1

Characteristics

White or off-white hygroscopic, odorless powder

2

Specific rotation[α]D20

-0.5° to +0.5°

3

Water

≤4.0%

4

Heavy metals

≤0.002%

5

Free aromatic amine

≤0.05%

6

Free iodine

The toluene layer shows no red or pink color

7

Free iodide

≤0.001%

8

Ionic compounds                 

≤0.05%

9

Limit of methanolIsopropyl alcoholmethoxyethanol

≤0.005%≤0.005%≤0.002%

10

3-chloro-1,2-propanediol

≤0.0025%

11

Related compounds

O-alkylated compounds≤0.6%Any individual impurity≤0.1%The sum of all impurities≤0.3%(other than O-alkylated compounds)

12

Assay

98.0 - 102.0%