SPL Set ID: 0b9e0d24-c6ca-4e22-9422-936e9d475eaa

Iopamidol Injection, USP formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intrathecal administration. Each mL of Iopamidol Injection, USP, 41% provides 408 mg iopamidol with 1 mg tromethamine and 0.26 mg edetate calcium disodium. The solution contains approximately 0.029 mg (0.001 mEq) sodium and 200 mg organically bound iodine per mL. Each mL of Iopamidol Injection, USP, 61% provides 612 mg iopamidol with 1 mg tromethamine and 0.39 mg edetate calcium disodium. The solution contains approximately 0.043 mg (0.002 mEq) sodium and 300 mg organically bound iodine per mL. The pH of Iopamidol Injection, USP contrast media has been adjusted to 6.5-7.5 with hydrochloric acid and/or sodium hydroxide. Pertinent physicochemical data are noted below. Iopamidol Injection, USP is hypertonic as compared to plasma and cerebrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively). Iopamidol Parameter 41% 61% Concentration (mgI/mL) 200 300 Osmolality @ 37°C (mOsm/kg water) 413 616 Viscosity (cP) @ 37°C 2.0 4.7 @ 20°C 3.3 8.8 Specific Gravity @ 37°C 1.216 1.328 Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]- 2,4,6-triiodo-5-lactamidoisophthalamide. Structural formula: MW 777.09 C 17 H 22 I 3 N 3 O 8 CAS-60166-93-0 Organically Bound Iodine: 49% structural-formula