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API-Gadodiamide CAS:131410-48-5

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Updated on: 2018-09-07 15:41
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Details

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

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