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PROPOFOL (CIVICA) Description (propofol injectable emulsion)

11 DESCRIPTION

Propofol Injectable Emulsion, USP is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration. The structural formula is:

ChemicalStructure

Chemical name: 2,6-diisopropylphenol

Molecular weight: 178.27

Propofol, USP is slightly soluble in water and, thus, is formulated in a white, oil-in-water emulsion. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. In addition to the active component, propofol, the formulation also contains soybean oil (100 mg/mL), glycerin (22.5 mg/mL), egg phospholipid (12 mg/mL); and disodium edetate (0.005%); with sodium hydroxide to adjust pH. The Propofol Injectable Emulsion, USP is isotonic and has a pH of 6 to 8.5.

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