Customization: | Available |
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Certification: | GMP, FDA, ISO |
Grade Standard: | Medicine Grade |
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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% | 9.11% |
Limit of free gadolinium(lll) | Not more than 0.3%(anhydrous basis) | Not finding |
LimitoffreeDiethylenetramine pentaaceticaoidbismethylamide | Not more than 0.7%(anhydrous basis) | 0.01% |
Limit of methylamine | Not more than 0.05% | 0.00% |
Limit of acetone, ethyl alcohol,isopropyl alcohol | ||
Acetone | Not more than 0.2% | 0.019% |
Ethyl alcohol | Not more than 0.2% | 0.001% |
Isopropyl alcohol | Not more than 0.2% | 0.002% |
Total impurity | Not more than 0.2% | 0.02% |
Related comounds | ||
Impurity A | Not more than 2.0% | 0.03% |
Impurity B | Not more than 2.0% | 0.12% |
Individual Impurity | Not more than 0.2% | 0.15% |
Total Impurity (except of Impurity A&B) | Not more than 0.5% | 0.13% |
Content of gadolinium | 26.0~29.0% | 28.5% |
Assay | 97.0~103.0% | 99.5% |
The material complies with the USP32 | complies |