Description
A white or almost white powder

Identification
IR - IR Spectrum
Retention time - The retention times of the two principal peaks in the chromatogram
Violet vapors - Violet vapors are evolved

TESTS
Specific rotation - between -0.5˚ and +0.5˚
Microbial limits - Not more than 100 cfu/g
Water - NMT 4.0%
Heaby metals - NMT 0.001%
Free Ioding - the toluene layer shows no red or pink color
Limit of free Iodide - NMT 10 ug of iodide per g
Limit of freearomatoc amine- NMT 0.05%
Limit of Calcium - NMT 5 ㎍/g
Limit of lonic compounds - NMT 0.02% as NaCl
Limit of Methanol - NMT 50 ㎍/g
Isopropyl alcohol - NMT 50 ㎍/g
Methoxy ethanol - NMT 50 ㎍/g


Related compounds
Total related compound - NMT 1.5%
Iodixanol related compoumd B - NMT 0.2%
Iodixanol related compoumd C - NMT 0.4%
Iodixanol related compoumd G - NMT 0.2%
Iohexol- NMT 0.6%
overalkylated related compound - NMT 1.0%
Any individual unspecified - NMT 0.2%
related compound
Total unspecified related - NMT 0.5%
compounds
Iodixanol related compoumd E - NMT 0.31%
Iodixanol related compoumd H - NMT 0.6%

ASSAY - NMT 98.6% to 101.0% (anhydrous basis)