Specification :: Iodipamide

Specification No. I01

3,3´-(Adipoyldiimino)bis[2,4,6-triiodobenzoic acid]

Molecular Formula: C₂₀H₁₄I₆N₂O₆
Molecular Weight: 1139.77
C.A.S. No.: [606-17-7]

Description: White crystalline powder.

Tests:	Limits:	Methods:
Identification: a) I.R. spectrum b) HPLC c) TLC d) identification B		USP 28, <197> NQ I 01, test No. 2 USP 28, <201> USP 28, page 1038
Heavy metals:	max. 0.002 %	USP 28, <231>
Iodine:	must pass USP 26, page 1038
Iodide:	max. 0.02 %	USP 28, page 990
Water (K.F. titration):	max. 1.0 %	USP 26, <921>
Residue on ignition:	max. 0.1 %	USP 26, <281>
Free aromatic amine (as 3-Amino-2,4,6-triiodobenzoic, acid, calculation based on dry substance:	max. 0.03 %	USP 28 , page 1038
Assay (Argentometric titration, calculation based on dry substance):	98.0 - 102.0 %	USP 28 , page 1038
Total sum of impurities (HPLC):	max. 1.0 % Area	USP 28, <622>
3-Aminobenzoic acid (HPLC):	max. 0.5 % Area	USP 28, <622>
3-Acetylamino-2,4,6-triiodobenzoic acid (HPLC):	max. 0.5 % Area	USP 28, <622>
3-Adipoylimino-2,4,6-triiodobenzoic acid (monoanilide) (HPLC):	max. 0.5 % Area	USP 28, <622>
2,4,6-triiodo-3-aminobenzoic acid (HPLC):	max. 0.5 % Area	USP 28, <622>
Penta-iodo-iodipamide (HPLC):	max. 0.5 % Area	USP 28, <622>
Any individual impurity-unknown (HPLC):	max. 0.1 % Area	USP 28, <622>
Methanol (GC):	max. 100 ppm	USP 28, <622>
Ethanol (GC):	max. 500 ppm	USP 28, <622>
Microbiological test:		USP 28, <622>
Bacteria	max. 10 000 cfu/g
Fungi	max. 100 cfu/g
Molds	max. 100 cfu/g
Escherichia coli in 1g	absent
Salmonella in 10 g	absent
Pseudomonas aeruginosa in 1g	absent
Staphylococcus aureus in 1g	absent
Pyrogenity test:	must be apyrogenic	NQ I 01, test No. 22
Shelf life: 2 years

*NQ = Norm of Quality