Iopromide
CAS: 73334-07-3
Category: Pharmaceutical Intermediates
| Purity | Reagent Grade ≥95%, Standard Grade ≥97%, High-Purity Grade ≥98%, Pharmaceutical Grade ≥97.0–102.5% ( |
| Molecular Formula | C18H24I3N3O8 |
| Molecular Weight | 791.11 |
| Appearance | White to pale yellow powder |
| Packaging | 1 mg/glass vial, 5 mg/glass vial, 10 mg/glass vial, 25 mg/glass vial, 50 mg/glass vial, 100 mg/glass vial, 250 mg/glass vial, 1 g/glass vial, 5 g/glass vial, 25 g/HDPE bottle, or 25 kg/fiber drum |
| Testing Indicators | Appearance — Visual inspection (white to pale yellow powder); Melting point — DSC or capillary method (broad transition at ~160°C, literature; no sharp mp, amorphous character); Boiling point — Distillation (840.9±65.0°C at 760 mmHg, predicted); Density — Hydrometer (2.173±0.06 g/cm³, predicted; 1.166–1.441 g/cm³ at 20°C, concentration-dependent for solutions); Refractive index — Abbe refractometer (1.3828–1.4660 at 20°C, concentration-dependent for solutions); Purity — HPLC-UV (≥95–99.5%, C18 column, acetonitrile:buffer gradient, λ=220–254 nm); Related substances — HPLC (impurity profiling including iopromide related compound A (5-amino-N,N-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-N-methyl-1,3-benzenedicarboxamide), related compound B (5-acetylamino analog), and other synthesis-related/degradation impurities); Assay — RP-HPLC or titrimetric (USP/EP/JP: 97.0–102.5% of C18H24I3N3O8, calculated on the anhydrous and solvent-free basis); Loss on drying — Gravimetric (≤0.5%); Residue on ignition — Gravimetric (≤0.1%); Heavy metals — Colorimetric/ICP-MS (≤10 ppm, JP/USP limit test); Free iodine — Colorimetric extraction test (toluene layer must show no red color); Identification — FTIR (characteristic peaks: N–H (amide) ~3300–3500 cm⁻¹, O–H (alcohol) ~3200–3400 cm⁻¹, aromatic C–H ~3000–3100 cm⁻¹, aliphatic C–H ~2850–2950 cm⁻¹, amide C=O ~1650–1680 cm⁻¹, C–O (alcohol) ~1050–1150 cm⁻¹, C–N ~1300–1350 cm⁻¹, C–O–C (methoxy) ~1100 cm⁻¹); UV spectrophotometry (λmax ~220–260 nm, triiodobenzene chromophore); ¹H NMR (DMSO-d₆: δ 2.80–3.20 ppm multiplet CH₂N (dihydroxypropyl), δ 3.30 ppm singlet OCH₃ (methoxyacetyl), δ 3.40–3.80 ppm multiplet CH(OH) (dihydroxypropyl), δ 3.90–4.20 ppm multiplet CH₂OH (dihydroxypropyl), δ 4.00 ppm singlet CH₂O (methoxyacetyl), δ 8.20 ppm broad singlet amide N–H); ¹³C NMR (DMSO-d₆: δ 35 ppm NCH₃, δ 40–45 ppm CH₂N, δ 55 ppm OCH₃, δ 60–65 ppm CH(OH), δ 65–70 ppm CH₂OH, δ 70–75 ppm CH₂O (methoxyacetyl), δ 120–150 ppm aromatic carbons, δ 165–170 ppm amide C=O); Mass spectrometry — LC-MS/MS (MRM mode, m/z 789.5→126.9, negative ESI, fragmentor 135 V, collision energy 12 V); Water content — Karl Fischer titration (GB/T 6283/EP 2.5.12); pH — Potentiometry (aqueous solution, neutral, pH ~7.0 for formulated solutions); Specific optical rotation — Not applicable (achiral compound, mixture of stereoisomers); Osmolality — Osmometer (low osmolality, ~290 mOsm/kg for 300 mgI/mL solution); Viscosity — Viscometer (low viscosity, ~4.6 mPa·s at 37°C for 300 mgI/mL solution); Solubility — Freely soluble in water and DMSO (90 mg/mL), practically insoluble in ethanol (96%) and acetone. |
| Storage Notes | Store in a cool, dry, well-ventilated area at 2–8°C. Protect from light, moisture, and air. Keep container tightly sealed. Store powder at -20°C for long-term stability (up to 3 years); at 4°C for 2 years. In solvent, store at -80°C for 6 months or at -20°C for 1 month. Hygroscopic and light-sensitive material; avoid prolonged exposure to light and humid conditions. The compound should be stored in tightly closed containers protected from light. Store away from strong oxidizing agents, strong bases, and incompatible substances. Use amber containers or light-protective wrapping for storage and transportation. |
| Lead Time | 10 days |
Iopromide (INN, also known as Ultravist, Iopromid, SHL 414C, or ZK 35760) is a non-ionic, triiodinated, water-soluble X-ray contrast medium (radiopaque agent) belonging to the benzenedicarboxamide class. It functions as a diagnostic aid for radiographic imaging by providing high radiopacity due to its three iodine atoms per molecule. Used as a pharmaceutical intermediate and active pharmaceutical ingredient (API) for the development and quality control of injectable contrast media formulations (e.g., Ultravist 150, Ultravist 240, Ultravist 300, Ultravist 370). Approved for clinical use in computed tomography (CT) scanning, urography, angiography, digital subtraction angiography (DSA), ventriculography, gastrointestinal angiography, and other radiographic procedures requiring enhanced visualization of vascular structures and soft tissues. It exhibits low osmolality, low viscosity, and high water solubility, resulting in excellent clinical tolerance, minimal pain during injection, and reduced risk of adverse reactions compared to ionic contrast agents. Also employed in analytical method development, pharmacokinetic studies, forced degradation studies, and quality control applications. ATC code: V08AB05.