CHANGZHOU HIGHASSAY® CHEMICAL CO., LTD

Item

Standards

Appearance

White to off-white, amorphous, hygroscopic, odorless powder

Identification

A: IR

B: HPLC

C: Masculine reaction

Specific rotation

-0.5°to +0.5°

Water

4.0%max

Heavy metals

0.001%max

Free iodine

The toluene layer shows no red or pink color

Limit of Free iodide

10ug/g max

Free aromatic amine

0.05%max

Limit of calcium

5ug/g max

Limit of Ionic compounds

0.02%max

Methanol

50ppm max

Isopropyl alcohol

50ppm max

Methoxyethanol

50ppm max

PM

50ppm max

1,3-dichloro-2-propanol

25ppm max

Related substances

Related compound B:0.20%max

Related compound C:0.40%max

Related compound E:0.30%max

Related compound F:0.20%max

Related compound G:0.20%max

Related compound H:0.60%max

Iohexol:0.60%max

Overalkylated related compounds: 1.0%max

Individual unspecified related compound: 0.20%max

Total unspecified related compounds: 0.50%

Total related compounds: 1.5%max

Microbial limits

100cfu/g max

Assay

98.6-101.0%