Specification I 13
IOSARCOL
3,5-Diacetamido-2,4,6-triiodobenzoyl-N-sarcosyl-N-methyl-D-glucamine
Molecular Formula: C21H29N4O9I3
Molecular Weight: 862.19
C.A.S. No.: [97702-82-4]
Description:White to very slightly yellow powder
| Tests: | Limits: | Methods: |
| Identification: a) I.R. spectrum b) HPLC c) decomposition test |
Ph. Eur. 4 th Ed. 2002, <2.2.24> NQ I13, test No. 2 NQ I13, test No. 3 |
|
| Clarity of 67.7% (w/v) aqueous solution: | clear | Ph. Eur. 4 th Ed. 2002, <2.2.1> |
| Color of 67.7% (w/v) aqueous solution: | better than Y 5 | Ph. Eur. 4 th Ed. 2002, <2.2.2> |
| pH of 67.7% (w/v) aqueous solution: | 5.0 7.4 | Ph. Eur. 4 th Ed. 2002, <2.2.3> |
| Water (K.F. titration): | max. 4.0 % | Ph. Eur. 4 th Ed. 2002, <2.5.12> |
| Sulphated ash: | max. 0.1 % | Ph. Eur. 4 th Ed. 2002, <2.4.14> |
| Conductivity: | max. 100 μS . cm-1 | Ph. Eur. 4 th Ed. 2002, <2.2.38> |
| Z isomer (HPLC): | 60.0 75.0 % | NQ I13, test No. 10 |
| E isomer (HPLC): | 25.0 40.0 % | NQ I13, test No. 11 |
| Specific rotation [α]D20 (c = 10, water): | - 3.1º to –1.3 º | Ph. Eur. 4 th Ed. 2002, <2.2.7> |
| Heavy metals (as Pb): | max. 10 ppm | Ph. Eur. 4 th Ed. 2002, <2.4.8> |
| Copper (Spectrophotometry): | max. 5 ppm | NQ I13, test No. 14 |
| 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> |
| Free aromatic amine: | max. 0.030 % | NQ I13, test No. 15 |
| Free iodide: | must pass NQ I13, test No. 16 | |
| Free iodine: | max. 0.01 % | NQ I13, test No. 17 |
| Diatrizoylsarcosin (HPLC): | max. 0.4 % | NQ I13, test No. 18 |
| Any other individual impurity (HPLC): | max. 0.4 % | NQ I13, test No. 18 |
| 3,5-Diacetamido-2,4,6-triiodobenzoyl sarcosin ethylester and methylester (HPLC): | max. 0.35 % Area | NQ I13, test No. 20 |
| Meglumine (TLC): | max. 0.5 % | NQ I13, test No. 21 |
| Ethanol (GC): | max. 1000 ppm | NQ I13, test No. 22 |
| Methanol (GC): | max. 100 ppm | NQ I13, test No. 23 |
| Ethyl acetate (GC): | max. 500 ppm | NQ I13, test No. 24 |
| Toluene (GC): | max. 100 ppm | NQ I13, test No. 25 |
| 2-propanol (GC): | max. 500 ppm | NQ I13, test No. 26 |
| Assay (Argentometry calculation based on dry substance): | 98.0 102.0 % | NQ I13, test No. 27 |
| Assay (HPLC): | 98.0 102.0 % | NQ I13, test No. 28 |
| Microbiological test: | ||
| Bacteria | max. 100 cfu/g | Ph. Eur. 4 th Ed. 2002, <2.6.12> |
| Fungi | max. 10 cfu/g | Ph. Eur. 4 th Ed. 2002, <2.6.12> |
| Escherichia coli in 1g | absent | Ph. Eur. 4 th Ed. 2002, <2.6.13> |
| Salmonella in 10 g | absent | Ph. Eur. 4 th Ed. 2002, <2.6.13> |
| Pseudomonas aeruginosa in 1g | absent | Ph. Eur. 4 th Ed. 2002, <2.6.13> |
| Staphylococcus aureus in 1g | absent | Ph. Eur. 4 th Ed. 2002, <2.6.13> |
| Bacterial endotoxines (LAL test): | max. 5 Endotoxin Unit/g | Ph. Eur. 4 th Ed. 2002, <2.6.14> |
| Shelf life: 1 year | ||
*NQ = Norm of Quality
This specification supersedes the specification No. I13, version 4 issued on June 25, 2004
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