Characteristics

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

Conform

Identification

A:IR spectrum

B: HPLC

C: Masculine reaction

Conform

Conform

Conform

Specific rotation

Between -0.5° and +0.5°

0°

Water

Not more than 4.0%

1.4%

Heavy metals

Not more than 0.001%

Conform

Free iodine

The toluene layer shows no red or pink color

Conform

Limit of free iodide

Not more than 0.001%

0.000%

Free aromatic amine

Not more than 0.05%

0.00%

Limit of calcium

Not more than 0.0005%

0.0001%

Limit of ionic compounds

Not more than 0.02%

0.00%

Methanol

Not more than 0.005%

ND

Isopropyl alcohol

Not more than 0.005%

ND

Propayleneglycol monomethyl ether

Not more than 0.005%

ND

Methoxyethanol

Not more than 0.005%

ND

1.3-dichloro-2-propanol

Not more than 0.0025%

ND

Related compounds

Iodixanol related comound B: Not more than 0.20%

Iodixanol related comound C: Not more than 0.40%

Iodixanol related comound E: Not more than 0.30%

Iodixanol related comound F: Not more than 0.20%

Iodixanol related comound G: Not more than 0.20%

Iodixanol related comound H: Not more than 0.60%

Iohexol: Not more than 0.60%

Overalkylated related compounds:Not more than 1.0%

Individual unspecified related compound:Not more than 0.2%

Total unspecified related compound:Not more than 0.5%

Total related compounds:Not more than 1.5%

0.09%

0.21%

0.11%

0.07%

0.12%

ND

0.15%

0.2%

0.06%

0.28%

1.1%

Microbial limits

Not more than 100cfu/g

Conform

Assay

98.6%-101.0%

99.1%