Analysis Item
Specification
Results
Idencification
A:Infrared absorption Should conforms with the standard spectrum
Conforms
B:The maximum absorption at the relevant wavelength specifiied
Microbial limits
500cfu/g
20cfu/g
Bacterial endotoxins
<3.5Eu/mg
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
0.01%
Isopropyl alcohol
0.05%
Total impurity
0.06%
Related comounds
Impurity A
Not more than 2.0%
0.10%
Impurity B
0.15%
Individual Impurity
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
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