Ultravist

DRUG DESCRIPTION

ULTRAVIST (iopromide) Injection is a nonionic, water soluble x-ray contrast agent for intravascular administration. Each bottle is to be used as a Pharmacy Bulk Package for dispensing multiple single dose preparations utilizing a suitable transfer device. The chemical name for iopromide is N,N'-Bis(2,3-dihydroxypropyl) –2,4,6–triiodo–5– [(methoxyacetyl)amino] –N-methyl–1,3-benzenedicarboxamide. Iopromide has a molecular weight of 791.12 (iodine content 48.12%).

Iopromide has the following structural formula:

ULTRAVIST (iopromide) Structural Formula Illustration

ULTRAVIST (iopromide injection) Injection is a nonionic, sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution of iopromide, containing 2.42 mg/mL tromethamine buffer and 0.1 mg/mL edetate calcium disodium stabilizer. ULTRAVIST (iopromide injection) Injection Pharmacy Bulk Package is available in three strengths:

  • 240 mg I/mL provides 498.72 mg/mL iopromide,
  • 300 mg I/mL provides 623.4 mg/mL iopromide,
  • 370 mg I/mL provides 768.86 mg/mL iopromide.

During the manufacture of ULTRAVIST (iopromide injection) Injection, sodium hydroxide or hydrochloric acid may be added for pH adjustment. ULTRAVIST (iopromide injection) Injection has a pH of 7.4 (6.5–8) at 25± 2°C, is sterilized by autoclaving and contains no preservatives.

The iodine concentrations (mg I/mL) available have the following physicochemical properties:

Property ULTRAVIST INJECTION ULTRAVIST INJECTION ULTRAVIST INJECTION
240 mg I/mL 300 mg I/mL 370 mg I/mL
Osmolality* (mOsmol/kg water) @ 37°C 483 607 774
Osmolarity* (mOsmol/L) @ 37°C 368 428 496
Viscosity (cP) @ 20°C 4.9 9.2 22
  @ 37°C 2.8 4.9 10
Density (g/mL) @ 20°C 1.262 1.330 1.409
  @ 37°C 1.255 1.322 1.399
*Osmolality was measured by vapor-pressure osmometry. Osmolarity was calculated from the measured osmolal concentrations.

Solutions of ULTRAVIST (iopromide injection) Injection 240 mg I/mL, 300 mg I/mL and 370 mg I/mL have osmolalities from approximately 1.1 to 2.7 times that of plasma (285 mOsmol/kg water).



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