Optiray Description

Chemical Name: N,N'-Bis(2,3-dihydroxypropyl)-5-[N-(2-hydroxyethyl)-glycolamido]-2,4,6-triiodoisophthalamide.
Molecular Formula: C₁₈H₂₄I₃N₃O₉.
Molecular Weight: 807.12.
Appearance: Ioversol is a fine, white, non-crystalline powder.
Solubility: Ioversol is very soluble in water, freely soluble in dimethylformamide, sparingly soluble in ethanol, slightly soluble in acetone and very slightly soluble in acetonitrile.
Melting Point: No melting point is observed.
COMPOSITION: Characteristics: Optiray formulations are clear, colourless to pale yellow, sterile, non-pyrogenic aqeous solutions. Crystallization does not occur at room temperature.
The pH of the Optiray formulations is adjusted between 6.0 and 7.4 with hydrochloric acid or sodium hydroxide.
Concentrations/mL: Optiray 300: Each millilitre of Optiray 300 (ioversol injection 64%) provides 636 mg of ioversol with 3.6 mg of tromethamine as a buffer and 0.2 mg of edetate calcium disodium as a stabilizer. Optiray 300 provides 30% (300 mg/mL) organically bound iodine.
Optiray 320: Each millilitre of Optiray 320 (ioversol injection 68%) provides 678 mg of ioversol with 3.6 mg of tromethamine as a buffer and 0.2 mg of edetate calcium disodium as a stabilizer. Optiray 320 provides 32% (320 mg/mL) organically bound iodine.
Optiray 350: Each millilitre of Optiray 350 (ioversol injection 74%) provides 741 mg of ioversol with 3.6 mg of tromethamine as a buffer and 0.2 mg of edetate calcium disodium as a stabilizer. Optiray 350 provides 35% (350 mg/mL) organically bound iodine.
Physical and Chemical Properties: See Table 1.

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The product does not contain a preservative and is intended for single dose use only.