Specification No. I12
IOHEXOL EP5
N,N'-Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodoisophthalamide
Molecular Formula: C19H26I3N3O9
Molecular Weight: 821.15
C.A.S. No.: [66108-95-0]
Description: White to off-white, hygroscopic powder. Very soluble in water, freely soluble in methanol and practically insoluble in methylene chloride.
| Tests: | Limits: | Methods: |
| Identification: a) I.R. spectrum b) HPLC |
Ph. Eur. 5th Ed. 2005, <2.2.24> Ph. Eur. 5 th Ed. 2005, page 1819 |
|
| Clarity of 10% (w/v) aqueous solution: | clear | Ph. Eur. 5th Ed. 2005, <2.2.1> |
| Color of 10% (w/v) aqueous solution: | max. Y7 | Ph. Eur. 5th Ed. 2005, <2.2.2> Method II |
| Related substances (HPLC): | Ph. Eur. 5th Ed. 2005, <2.2.29> | |
| Sum of impurities B, C, D and E (HPLC): | max. 0.6% | Ph. Eur. 5th Ed. 2005, page 1819-20 |
| Sum of impurities A and H (HPLC): | max. 0.5% | Ph. Eur. 5th Ed. 2005, page 1819-2 |
| Impurity O (HPLC): | max. 0.1% | Ph. Eur. 5th Ed. 2005, page 1819-20 |
| Impurity I (HPLC): | max. 0.1% | Ph. Eur. 5th Ed. 2005, page 1819-20 |
| Any other impurity (HPLC): | max. 0.1% | Ph. Eur. 5th Ed. 2005, page 1819-20 |
| Sum of all impurities (HPLC): | max. 1.5% | Ph. Eur. 5th Ed. 2005, page 1819-20 |
| Any individual impurity (TLC): | max. 0.2% | Ph. Eur. 5th Ed. 2005, page 1820 |
| 3-Chloropropane-1,2-diol (GC): | max. 25 ppm | Ph. Eur. 5th Ed. 2005, page 1820 |
| Free aromatic amine: | max. 500 ppm | Ph. Eur. 5th Ed. 2005, page 1820-21 |
| Iodide: | max. 10 ppm | Ph. Eur. 5th Ed. 2005, page 1821 |
| Ionic compounds (as sodium chloride): | max. 0.01% | Ph. Eur. 5th Ed. 2005, page 1821 |
| Heavy metals: | max. 10 ppm | Ph. Eur. 5th Ed. 2005, <2.4.8> |
| Water (K.F. titration): | max. 4.0% | Ph. Eur. 5th Ed. 2005, <2.5.12> |
| Assay (Argentometry, calculation based on dry substance): | 98.0 – 101.0% | Ph. Eur. 5th Ed. 2005, page 1821 |
| Methanol (GC): | max. 50 ppm | Ph. Eur. 5th Ed. 2005, <2.2.28> NQ I12/EP, test No. 19 |
| 2-Methoxyethanol (GC): | max. 50 ppm | Ph. Eur. 5th Ed. 2005, <2.2.28> NQ I12/EP, test No. 20 |
| 2-Propanol (GC): | max. 100 ppm | Ph. Eur. 5th Ed. 2005, <2.2.28> NQ I12/EP, test No. 21 |
| Ethanol (GC): | max. 200 ppm | Ph. Eur. 5th Ed. 2005, <2.2.28> NQ I12/EP, test No. 22 |
| Ethyl acetate (GC) | max. 50 ppm | Ph. Eur. 5th Ed. 2005, <2.2.28> NQ I12/EP, test No. 23 |
| Bacterial endotoxins (LAL test): | max. 0.2 EU/ 50 mg of iodine | Ph. Eur. 5th Ed. 2005, <2.6.14> |
| Microbiological test: | ||
| Bacteria | max. 100 cfu/g | Ph. Eur. 5th Ed. 2005, <2.6.12> |
| Fungi | max. 10 cfu/g | Ph. Eur. 5th Ed. 2005, <2.6.12> |
| Escherichia coli in 1 g | absent | Ph. Eur. 5th Ed. 2005, <2.6.13> |
| Salmonella in 10 g: | absent | Ph. Eur. 5th Ed. 2005, <2.6.13> |
| Pseudomonas aeruginosa in 1g | absent | Ph. Eur. 5th Ed. 2005, <2.6.13> |
| Staphylococcus aureus in 1g: | absent | Ph. Eur. 5th Ed. 2005, <2.6.13> |
| Shelf life: 2 years | ||
Impurities A, B, C, D, E, H, I, O correspond to those specified in Ph. Eur. 5 th Edition, page 1821-22
*NQ = Norm of Quality
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