|
Product name
|
Iopromide EP
|
|
CAS NO.
|
73334-07-3
|
|
Appearance
|
White or slightly yellowish powder
|
|
Identification
|
A: IR
|
|
Appearance of solution
|
Clear and not more intensely colored than reference solution BY6, B6 and Y6
|
|
Conductivity
|
50uS/cm max
|
|
Impurity A and related primary aromatic amines
|
0.01%max
|
|
Impurity B
|
1.5%max
|
|
Related substance
|
Impurity E: 0.5%max
|
|
Unspecified impurities: 0.1%max
|
|
Impurity D: 1.0%max
|
|
Impurity C: 0.5%max
|
|
Impurity F: 0.2%max
|
|
Unspecified impurities: 0.1%max
|
|
Free iodine
|
The upper layer remains colorless
|
|
Free iodide
|
0.0002%max
|
|
Heavy metals
|
0.001%max
|
|
Water
|
1.5%max
|
|
Sulfated ash
|
0.1%max
|
|
Bacterial endotoxins
|
<1.0 IU/G
|
|
Isomer distribution
|
E1and Z1: 40.0% to 51.0%
E2 and Z2: 49.0% to 60.0%
|
|
Assay
|
97.0-102.5%
|
>>Alphabetical order
