SPL Set ID: 6218b1e1-cbc3-4c14-bec7-528ac163a561

EOVIST (gadoxetate disodium) is a paramagnetic contrast agent administered for MRI. EOVIST is provided as a sterile, clear, colorless to pale yellow aqueous solution for intravenous injection. EOVIST contains the active pharmaceutical ingredient, gadoxetate disodium (Gd‑EOB‑DTPA). The chemical name for gadoxetate disodium is (4S)-4-(4-Ethoxybenzyl)-3,6,9-tris(carboxylatomethyl)-3,6,9-triazaundecanedioic acid, gadolinium complex, disodium salt. Gadoxetate disodium has a molecular weight of 725.72 and an empirical formula of GdC 23 H 28 N 3 O 11 Na 2 . The structural formula of gadoxetate disodium in aqueous solution is: Each mL of EOVIST contains 181.43 mg (0.25 mmol) of gadoxetate with 1.00 mg of caloxetate trisodium, 1.21 mg of trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment), and water for injection. EOVIST contains no antimicrobial preservative. Pertinent physiochemical properties of EOVIST are provided in Table 2. Table 2 Physicochemical Properties Osmolality at 37°C (Osm/kg H 2 O) 0.688 Viscosity at 37°C (cP) 1.19 Density at 37°C (g/mL) 1.088 pH 6.8-8 Structure