SPL Set ID: ff9456ef-c45a-450d-9004-a684af2bcc59

Iohexol, USP is a nonionic radiographic contrast agent available as: Iohexol injection for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity use. The chemical name of iohexol, USP is N,N’ -Bis(2,3-dihydroxypropyl)-5-[ N -(2,3-dihydroxypropyl) acetamido]-2,4,6-triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula: Iohexol Injection, USP is a sterile, pyrogen-free, clear, colorless to pale yellow solution available in following concentrations of iodine: Iohexol Injection USP, 300 mg iodine/mL: Each mL contains 647 mg iohexol, USP (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium, USP; 1.21 mg tromethamine, USP and water for injection. Iohexol Injection USP 350 mg iodine/mL: Each mL contains 755 mg iohexol, USP (providing 350 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium, USP; 1.21 mg tromethamine, USP and water for injection. The pH is adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide. Iohexol injection contain no preservatives and no ingredient made from a gluten-containing grain (wheat, barley, or rye). Iohexol injection have the following physical properties: Table 21: Physicochemical Properties of Iohexol Injection Dosage Form Concentration (mg iodine/mL) Osmolality * (mOsmol/kg water) Absolute Viscosity (cP) Specific Gravity 20°C 37°C 37°C Injection 300 659 11.48 6.05 1.344 350 774 21.48 12.16 1.4054 * By Freezing Point Depression Osmometer. Iohexol injection has osmolalities from approximately 2.4 times that of plasma (285 mOsmol/kg water) or cerebrospinal fluid (301 mOsmol/kg water) as shown in the above table and are hypertonic. 1