Product name
|
Iopromide EP
|
CAS NO.
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73334-07-3
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Appearance
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White or slightly yellowish powder
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Identification
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A: IR
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Appearance of solution
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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
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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
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E1and Z1: 40.0% to 51.0%
E2 and Z2: 49.0% to 60.0%
|
Assay
|
97.0-102.5%
|