Phytomenadione, also known as vitamin K₁, phylloquinone, or phytonadione, is a vitamin found in food and used as a dietary supplement. It is on the World Health Organization's List of Essential Medicines. Chemically it is 2-methyl-3-phytyl-1,4-naphthoquinone with molecular formula C31H46O2 and CAS number 84-80-0. Phytonadione is a fat soluble yellow crystalline compound that functions as an obligate cofactor for the gamma glutamyl carboxylase reaction that converts specific glutamate residues to gamma carboxyglutamate in hepatic and extrahepatic proteins, most notably clotting factors II, VII, IX and X and regulatory proteins C and S. Pharmaceutical forms include oral tablets and solutions, parenteral oil based and micellar injection formulations. It is lipophilic and practically insoluble in water, soluble in organic solvents, and is light and oxygen sensitive, requiring amber packaging and controlled storage conditions. Standard analytical techniques for identity and assay include HPLC with UV detection, LC MS for profiling, and UV visible spectroscopy for concentration determination.
Parent: Phytonadione
Parent: Phytonadione
Parent: Phytonadione
Parent: Phytonadione
Parent: Phytonadione
Pharmaceutical grade phytonadione is manufactured and tested to limit related substances and degradation products arising from oxidative or side chain cleavage pathways. Typical quality targets for finished active pharmaceutical ingredient include assay purity in the high 90s percent range on an anhydrous basis and an impurity profile where individual related compounds are generally controlled below 0.5 to 1.0 percent by area and total related substances are typically limited to about 2.0 to 3.0 percent, depending on the monograph or product specification. Common related compounds and impurities monitored by HPLC or LC MS include menadione (2-methyl-1,4-naphthoquinone), oxidized phytonadione derivatives such as epoxides and ketone variants, phytyl side chain cleavage products, and positional isomers of the naphthoquinone nucleus. Residual solvents from manufacture and trace metal contaminants are controlled separately in accordance with ICH Q3C and Q3D guidance.
Yes, Phytonadione is the accepted pharmaceutical name for vitamin K1, also called phylloquinone or phytomenadione. It is the primary dietary form of vitamin K used therapeutically.
Phytonadione is used to prevent and treat vitamin K deficiency and to promote synthesis of vitamin K dependent clotting factors. Clinically it is used for prophylaxis of hemorrhagic disease of the newborn, reversal of vitamin K antagonist anticoagulation when appropriate, and treatment of documented vitamin K deficiency states.
Another name for phytonadione is phylloquinone. It is also referred to as phytomenadione or vitamin K1.
Phytonadione can be administered orally, intramuscularly or intravenously depending on the formulation and clinical indication. Newborn prophylaxis is commonly given intramuscularly, oral dosing is used for routine supplementation, and intravenous administration is reserved for rapid correction under clinical supervision with appropriate monitoring.
