SPL Set ID: 6cb6ca5f-b249-49b0-a9eb-8aa583da7c74

11.1 Chemical Characteristics OPTIRAY (ioversol injection) is a non-ionic radiographic contrast agent. OPTIRAY formulations are sterile, nonpyrogenic, aqueous solutions intended for intravascular use. Each bottle is to be used as a Pharmacy Bulk Package for dispensing multiple single dose preparations utilizing a suitable transfer device. Ioversol is designated chemically as N,N' -Bis (2,3-dihydroxypropyl)-5-[ N -(2-hydroxyethyl) -glycolamido] -2,4,6-triiodoisophthalamide. The molecular weight of ioversol is 807.11 and the organically bound iodine content is 47.2%. The structural formula of ioversol is as follows: OPTIRAY Pharmacy Bulk Package is available in two strengths: OPTIRAY 320 (ioversol injection 68%): Each mL contains 320 mg organically bound iodine, 678 mg of ioversol, 3.6 mg tromethamine, 0.2 mg edetate calcium disodium. OPTIRAY 350 (ioversol injection 74%): Each mL contains 350 mg organically bound iodine, 741 mg ioversol, 3.6 mg tromethamine, 0.2 mg edetate calcium disodium. The pH of the OPTIRAY formulations has been adjusted to 6.0 to 7.4 with hydrochloric acid or sodium hydroxide. All solutions are sterilized by autoclaving and contain no preservatives. Ioversol does not dissociate in solution. chem-structure 11.2 Physical Characteristics Some physical and chemical properties of these formulations are listed below: OPTIRAY 320 OPTIRAY 350 Ioversol content (mg/mL) 678 741 Iodine content (mg l/mL) 320 350 Osmolality (mOsm/kg water) 702 792 Viscosity (cps) at 25°C 9.9 14.3 at 37°C 5.8 9.0 Specific Gravity at 37°C 1.371 1.405 The OPTIRAY formulations are clear, colorless to pale yellow solutions containing no undissolved solids. Crystallization does not occur at room temperature. OPTIRAY solutions have osmolalities 2.3 to 2.8 times that of plasma (285 mOsm/kg water) as shown in the above table and are hypertonic under conditions of use.