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IODIXANOL
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11.1 Chemical Characteristics VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo- 1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%) VISIPAQUE (C 35 H 44 I 6 N 6 O 15 ) has the following structural formula: VISIPAQUE is available in two strengths: VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium. VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium. Sodium chloride and calcium chloride have been added, resulting in an isotonic solution for injection providing for both concentrations a sodium/calcium ratio equivalent to blood. The pH is adjusted to 7.4 with hydrochloric acid and/or sodium hydroxide to achieve a range between pH 6.8 and 7.7 at 22°C. Chemical Structure 11.2 Physical Characteristics The two concentrations of VISIPAQUE Injection (270 mg Iodine/mL and 320 mg Iodine/mL) have the following physical properties: TABLE 4 Physical Properties of VISIPAQUE Parameter Concentration (mg Iodine/mL) 320 270 Osmolality (mOsmol/kg water) 290 290 Viscosity (cP) @ 20°C 26.6 12.7 @ 37°C 11.8 6.3 Density (g/mL) @ 20°C 1.369 1.314 @ 37°C 1.356 1.303
11.1 Chemical Characteristics VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C 35 H 44 I 6 N 6 O 15 ) has the following structural formula: VISIPAQUE is available in two strengths: VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium. VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium. Sodium chloride and calcium chloride have been added, resulting in an isotonic solution for injection providing for both concentrations a sodium/calcium ratio equivalent to blood. The pH is adjusted to 7.4 with hydrochloric acid and/or sodium hydroxide to achieve a range between pH 6.8 and 7.7 at 22°C. Chemical Structure 11.2 Physical Characteristics The two concentrations of VISIPAQUE Injection (270 mg Iodine/mL and 320 mg Iodine/mL) have the following physical properties: TABLE 4 Physical Properties of VISIPAQUE Parameter Concentration (mg Iodine/mL) 320 270 Osmolality (mOsmol/kg water) 290 290 Viscosity (cP) @ 20°C 26.6 12.7 @ 37°C 11.8 6.3 Density (g/mL) @ 20°C 1.369 1.314 @ 37°C 1.356 1.303
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11.1 Chemical Characteristics VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C 35 H 44 I 6 N 6 O 15 ) has the following structural formula: VISIPAQUE is available in two strengths: VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium. VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium. Sodium chloride and calcium chloride have been added, resulting in an isotonic solution for injection providing for both concentrations a sodium/calcium ratio equivalent to blood. The pH is adjusted to 7.4 with hydrochloric acid and/or sodium hydroxide to achieve a range between pH 6.8 and 7.7 at 22°C. Chemical Structure 11.2 Physical Characteristics The two concentrations of VISIPAQUE Injection (270 mg Iodine/mL and 320 mg Iodine/mL) have the following physical properties: TABLE 4 Physical Properties of VISIPAQUE Parameter Concentration (mg Iodine/mL) 320 270 Osmolality (mOsmol/kg water) 290 290 Viscosity (cP) @ 20°C 26.6 12.7 @ 37°C 11.8 6.3 Density (g/mL) @ 20°C 1.369 1.314 @ 37°C 1.356 1.303
11.1 Chemical Characteristics VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo- 1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%) VISIPAQUE (C 35 H 44 I 6 N 6 O 15 ) has the following structural formula: VISIPAQUE is available in two strengths: VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium. VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium. Sodium chloride and calcium chloride have been added, resulting in an isotonic solution for injection providing for both concentrations a sodium/calcium ratio equivalent to blood. The pH is adjusted to 7.4 with hydrochloric acid and/or sodium hydroxide to achieve a range between pH 6.8 and 7.7 at 22°C. Chemical Structure 11.2 Physical Characteristics The two concentrations of VISIPAQUE Injection (270 mg Iodine/mL and 320 mg Iodine/mL) have the following physical properties: TABLE 4 Physical Properties of VISIPAQUE Parameter Concentration (mg Iodine/mL) 320 270 Osmolality (mOsmol/kg water) 290 290 Viscosity (cP) @ 20°C 26.6 12.7 @ 37°C 11.8 6.3 Density (g/mL) @ 20°C 1.369 1.314 @ 37°C 1.356 1.303