Click image to view original image
|
Analysis Item |
Specification |
Results |
|
Idencification |
A:Infrared absorption Should conforms with the standard spectrum
|
Conforms |
|
B:The maximum absorption at the relevant wavelength specifiied |
Conforms |
|
|
Microbial limits |
500cfu/g |
20cfu/g |
|
Bacterial endotoxins |
<3.5Eu/mg |
Conforms |
|
Water content |
Between 3.0% and 14.0% |
10.00% |
|
Limit of free gadolinium(lll) |
Not more than 0.3%(anhydrous basis) |
Not finding |
|
LimitoffreeDiethylenetramine pentaaceticaoidbismethylamide |
Not more than 0.7%(anhydrous basis) |
0.090% |
|
Limit of methylamine |
Not more than 0.05% |
0.001% |
|
Limit of acetone, ethyl alcohol,isopropyl alcohol |
||
|
Acetone |
Not more than 0.2% |
0.00% |
|
Ethyl alcohol |
Not more than 0.2% |
0.01% |
|
Isopropyl alcohol |
Not more than 0.2% |
0.05% |
|
Total impurity |
Not more than 0.2% |
0.06% |
|
Related comounds |
||
|
Impurity A |
Not more than 2.0% |
0.10% |
|
Impurity B |
Not more than 2.0% |
0.15% |
|
Individual Impurity |
Not more than 0.2% |
0.05% |
|
Total Impurity (except of Impurity A&B) |
Not more than 0.5% |
0.29% |
|
Content of gadolinium |
26.0~29.0% |
28.7% |
|
Assay |
97.0~103.0% |
99.8% |
|
The material complies with the USP32 |
complies |
|
