API

Description
White or almost white crystalline powder, freely soluble in water

Identification
Concordant with the reference standard spectrum

Specific optical rotation
+0.05° ~ - 0.05° (as anhydrous basis)

Impurity
Clarity of solution - Clear and no foreign matter is detected
Ethanol - Not more than 2,000 ppm
Related substances
 - Butrol : Not more than 0.05%
 - Other related substances : Not more than 0.05%
 - Total related substaces : Not more than 0.30%
Free gadolinium - Not more than 0.01% (as anhydrous basis)
Heavy metals - Not more than 20 ppm

Bacterial endotoxins
Less than 1.3 EU/g

Water
Not more than 7.0 %

Content of gadolinium
255 ~ 265 mg/g

Assay
98.0~102.0% (as anhydrous basis)

Chemical Name
Gadolinium(III) 2,2',2''-(10-((2R,3S)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-
tetraazacyclododecane-1,4,7-triyl)triacetate

Molecular Formula
C₁₈H₃₁GdN₄O₉

Molecular Weight
604.72

Therapeutic Function
MRI Contrast media