Description
A white or wellowish white powder, freely soluble in water

Identification
IR
Concordant with the reference standard spectrum

TEST
Water
between 3.0% and 14.0%
Clarity of solution
clear and colorless solution
Limit of free gadolinium(III)
NMT 0.3% (anhydrous basis)
Limit of diethylenetriamine
NMT 0.7% (anhydrous basis)
pentaacetic acid bismethylamide
Content of gadolinium
between 26.0 and 29.0% (anhydrous basis)
Limit of methylamine
NMT 0.05%

Limit of
Acetone
NMT 0.2%
Ethyl alcohol
NMT 0.2%
Isopropyl alcohol
NMT 0.2%
Sum of all three analytes
NMT 0.2% (anhydrous basis)

Related compound
Impurity A&B
NMT 2.0%
Individual impurityB
NMT 0.2%
Total Impurity (except Impurity A&B)
NMT 0.5%

Microbial limits
Total aerobic microbial counts
NMT 500 cfu/g
molds and yeast counts
NMT 50 cfu/g

Bacterial Endotoxin
NMT 3.5 USP EU/g

Assay
between 97.0% and 103.0%