Vitamin K1 (Phylloquinone)

Vitamin K1 (Phylloquinone)

Phytonadione · C31H46O2

Bulk vitamin K1 (phytonadione) supplied as USP/Ph Eur grade oil assaying 97.0–103.0%, and as 1% and 5% dispersible powders for supplement, pharmaceutical and food-fortification manufacture.

Specifications

Chemical namePhytonadione (phytomenadione, phylloquinone); 2-methyl-3-[(2E,7R,11R)-3,7,11,15-tetramethylhexadec-2-enyl]naphthalene-1,4-dione
CAS number84-80-0
Molecular formulaC31H46O2
Molecular weight450.70 g/mol
Assay97.0–103.0% of C31H46O2 (USP/FCC); Z-isomer NMT 21.0%. Ph Eur/BP phytomenadione: trans-isomer NLT 75.0%. Dilutions: 1.0% and 5.0% min on powder grades
AppearanceOil: clear yellow to amber, very viscous, odourless to nearly odourless liquid. Powder: yellow to light-yellow free-flowing granular powder
SolubilityPractically insoluble in water; sparingly soluble in ethanol (96%); soluble in chloroform and ether; miscible with fatty oils. CWS/SD powders disperse in water
Refractive index / densitynD25 1.523–1.526; relative density about 0.967 (oil grade)
Particle sizePowder grades: typically 100% through 40 mesh, not less than 90% through 60 mesh (buyer specification accepted)
Loss on dryingPowder grades NMT 5.0%; not applicable to oil grade
Heavy metalsLead NMT 2 mg/kg; arsenic NMT 1 mg/kg; cadmium NMT 1 mg/kg; mercury NMT 0.1 mg/kg
Shelf life & storage24 months from manufacture. Oil grade 2–8 °C under nitrogen; powder grades below 25 °C. Protect from light, air and moisture in tightly closed original containers
HS code2936.29 (29362930)
Vitamin K1, known pharmacopoeially as phytonadione (USP) or phytomenadione (Ph Eur/BP), is the 2-methyl-3-phytyl-1,4-naphthoquinone form of vitamin K, CAS 84-80-0, molecular formula C31H46O2, molecular weight 450.70. In the body it acts as the cofactor for gamma-glutamyl carboxylase, the enzyme that carboxylates glutamate residues on vitamin K-dependent Gla proteins, including the coagulation factors II, VII, IX and X and the bone protein osteocalcin. Commercial material is produced by chemical synthesis and exists as a mixture of E (trans) and Z (cis) isomers; USP requires 97.0–103.0% of total C31H46O2 with not more than 21.0% Z-isomer, while the Ph Eur/BP monograph for phytomenadione requires not less than 75.0% of the trans isomer. We supply vitamin K1 in two commercial presentations. The neat oil is a clear yellow to amber, very viscous liquid with a refractive index of 1.523–1.526 at 25 °C and a relative density of about 0.967; it is practically insoluble in water, sparingly soluble in ethanol (96%) and miscible with fatty oils, which makes it directly usable in softgel fills, oil-based emulsions and lipid premixes. For dry blending we offer 1% and 5% cold-water-dispersible and spray-dried powders in which the oil is encapsulated on a modified starch, acacia or maltodextrin matrix, giving a free-flowing yellow powder suitable for direct compression, sachet blends and beverage fortification. Both forms are light-sensitive and are handled, filled and packed under nitrogen with light protection. Each batch is released against an in-house certificate of analysis covering HPLC assay and isomer ratio, appearance, refractive index or loss on drying as applicable, residual solvents, heavy metals (lead, arsenic, cadmium, mercury) and microbiological limits, with third-party verification available on request. Documentation supplied with export shipments includes the CoA, MSDS, allergen, GMO, BSE/TSE and nitrosamine declarations, and a stability/retest statement. Material is despatched from India with the export packing described below, under temperature-controlled conditions where the buyer's destination and transit time require it.

Applications

Vitamin K1 softgel capsulesVitamin D3 and K1 combinationsBone-health tablet blendsMultivitamin premixesInfant and clinical nutritionFortified beverages and dairyPharmaceutical formulationAnimal feed premixesTopical cosmetic emulsions

Available grades

USP (Phytonadione), Ph Eur / BP (Phytomenadione), FCC, food grade, pharmaceutical grade, feed grade; supplied as neat oil and as 1% and 5% cold-water-dispersible or spray-dried powder

Packaging: Oil grade in 1 kg, 5 kg and 25 kg amber glass or aluminium-lined HDPE containers, nitrogen-flushed and light-protected; powder grades in 20 kg and 25 kg fibre drums with double food-grade LDPE liner. Palletised, shrink-wrapped and marked to buyer instruction for sea or air freight; cold-chain and smaller sample packs available on request.

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