Phytonadione, commonly known as Vitamin K1, Phylloquinone, or Phytomenadione, is a fat-soluble vitamin and an important pharmaceutical active ingredient. It has the CAS Number 84-80-0, molecular formula C31H46O2, and molecular weight 450.70 g/mol. Phytonadione is the naturally occurring form of Vitamin K and plays an essential biological role in the activation of several blood-clotting proteins.
Phytonadione belongs to the vitamin K family and is chemically classified as a 1,4-naphthoquinone derivative containing a phytyl side chain. Its established chemical identity and pharmaceutical importance make it a widely used active ingredient in vitamin K formulations and pharmaceutical preparations.
PHYTOnadione Chemical Profile
Phytonadione is described in the International Pharmacopoeia as a clear, yellow to amber-coloured, very viscous liquid that is odorless or almost odorless. It is practically immiscible with water, sparingly miscible with ethanol, and freely miscible with chloroform and ether. These physicochemical characteristics are important when developing formulations containing Vitamin K1.
The International Pharmacopoeia identifies Phytomenadione as Phylloquinone and Vitamin K1 and assigns it CAS Number 84-80-0. The relative molecular mass is 450.7.
PHYTOnadione Pharmaceutical Applications
Vitamin K1 is an essential cofactor for the enzyme gamma-glutamyl carboxylase. This biochemical process is required for the formation and activation of several vitamin K-dependent coagulation factors, including Factors II, VII, IX and X. Phylloquinone therefore has an important physiological role in normal blood coagulation.
Pharmaceutical Phytonadione is used in Vitamin K preparations and formulations designed to provide Vitamin K1. It may be incorporated into oil-based or other suitable pharmaceutical dosage forms because of its pronounced lipophilicity and very low water miscibility.
USP pharmaceutical and dietary-supplement standards recognize Phytonadione as Vitamin K1 and provide a USP Phytonadione Reference Standard for analytical testing. Current USP publications also identify Phytonadione as the Vitamin K component of various oil-soluble vitamin preparations.
PHYTOnadione Quality And Pharmacopoeial Standards
The International Pharmacopoeia Twelfth Edition provides a specific monograph for Phytomenadione. The monograph requires Phytomenadione to contain not less than 97.0% and not more than 102.0% of C31H46O2. This is an important numerical pharmacopoeial value for API quality control.
The International Pharmacopoeia also specifies a refractive index of 1.525–1.529. Acidity or alkalinity is controlled by dissolving 1 g in 20 mL of dehydrated ethanol, with the resulting solution required to be neutral to litmus paper.
For related substances, the International Pharmacopoeia uses thin-layer chromatography. Any spot obtained with the test solution, other than the principal spot, must not be more intense than the spot obtained with the specified menadione comparison solution. This is a comparative pharmacopoeial impurity test rather than a conventional numerical total-impurity percentage limit.
PHYTOnadione Identification Testing
The International Pharmacopoeia provides characteristic ultraviolet absorption criteria for Phytomenadione. A 10 μg/mL solution in 2,2,4-trimethylpentane shows characteristic maxima at approximately 243, 249, 261 and 270 nm. Another concentration shows a maximum at approximately 327 nm. These spectral characteristics support identification and quality assessment of Vitamin K1.
Because Phytonadione is sensitive to environmental conditions, the International Pharmacopoeia recommends keeping it in a tightly closed container protected from light. Protection from light is particularly relevant for maintaining the quality of Vitamin K1 during storage and pharmaceutical handling.
PHYTOnadione API For Pharmaceutical Manufacturing
Phytonadione API is an established pharmaceutical ingredient with a well-defined molecular identity, pharmacological role and pharmacopoeial quality profile. For pharmaceutical manufacturing, appropriate control of assay, identity, refractive index, related substances, appearance and storage conditions helps maintain consistent API quality.
Phytonadione should also be clearly distinguished from other Vitamin K forms such as Menaquinones and Menadione. Vitamin K1 specifically refers to Phytonadione or Phylloquinone with CAS Number 84-80-0 and molecular formula C31H46O2.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |