Vitamin K2

Single-ingredient vitamin K2 reference formula at 100 mcg per serving, developed as a capsule or softgel.

Vitamin K2 is a reference formula for brands building a single-ingredient menaquinone product at a default amount of 100 mcg (0.1 mg) of vitamin K2 per serving. Vitamin K2 is the only active ingredient, so the development work sits with a microgram-level fat-soluble vitamin: the menaquinone form (MK-7 or MK-4), the premix or oil that carries it, and content uniformity in every unit.

Capsule is the lead format because a menaquinone premix blends into a standard fill, while a softgel dissolves the vitamin in an oil fill. Options of 45, 50 and 90 mcg sit beside the default, and the amount is a decision for the brand and its market review.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
Vitamin K2100 mcg (default amount)Menaquinone-7 as a premix on a carrier, specified on vitamin K2 content; 100 mcg vitamin K2 per servingMenaquinone-4 as a separate specification, or an oil-based menaquinone grade for the softgel, with the input recalculated to 100 mcg of vitamin K2

Amounts are stated as mcg of vitamin K2; 100 mcg equals 0.1 mg. The two common menaquinone forms are different molecules: menaquinone-7 is C46H64O2, 649.0 g/mol (PubChem CID 5287554) and menaquinone-4 is C31H40O2, 444.6 g/mol (CID 5282367). The form is set in the specification, and a switch between the two is a new product.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around daily vitamin K2 intake and bone nutrition. Vitamin K2 is included as the only active so that the form, the amount and the carrier can be set without interaction with other actives.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Daily vitamin K2 intakeVitamin K2Included because vitamin K takes part in the modification of 7 proteins in blood coagulation and in the maturation of 11 or 12 further proteins, and menaquinones, known as vitamin K2, are mostly of bacterial origin and enter the diet mainly through fermented cheeses [2]. Evidence: Referenced
Bone nutritionVitamin K2A meta-analysis of 16 randomized trials with 6,425 postmenopausal women found a significant improvement in lumbar spine bone mineral density with vitamin K2, no significant overall difference in fracture incidence, and a lower fracture incidence after one heterogeneous study was excluded [1]. Evidence: Mixed

The amount is a stated tier. The review in [2] concludes that current knowledge does not allow a decisive conclusion on a link between vitamin K and osteoporosis, so amount, claims and target market are brand decisions reviewed for each sales market.

Available Formats

The vitamin K2 reference formula is built for a capsule version and a softgel version; counts per serving are design choices that the brand can adjust.

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Capsule1 capsule100 mcg60 or 90 capsulesCellulose, hypromellose shell, magnesium stearateLead format; premix in a small fill
Softgel1 softgel100 mcg30 or 60 softgelsVegetable oil, suspending agent, shell, glycerinOil fill with the vitamin dissolved

Raw Material Input & Fill (Design Estimate)

Design estimates. The input is the vitamin K2 amount divided by the assumed assay of the raw material, taken at a 0.2% menaquinone-7 premix (2 mg per gram) on a carrier, so 100 mcg of vitamin K2 needs 50 mg of premix per unit.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Capsule50 mg premix (100 mcg vitamin K2)200 mg per capsule150 mgBlend uniformity, fill weight variation, content assay of vitamin K2
SoftgelMenaquinone oil grade for 100 mcg400 mg fillCarrier oil to fill weightDissolution in the oil, shell compatibility, light exposure, content assay of vitamin K2

Tablet, powder and gummy versions are separate projects, because a light-sensitive micro-dose needs its own protection and uniformity plan in those systems.

Formulation Considerations

Micro-dose in a premix. At 100 mcg, the active is far below a milligram, and the premix carries it into a 200 mg fill. The premix dilution and a stepwise blending order are set first, and content uniformity of the first units decides whether the dilution holds.
Menaquinone form. MK-7 and MK-4 differ in structure and molecular weight, and the reference label names only vitamin K2. The specification states which form is used, with its assay and cis-trans content, and any change of form comes with new stability data.
Light and oxidation. Menaquinones are lipid-soluble compounds that are handled away from light and oxygen. Opaque shells, an amber bottle and potency through shelf life are checked in stability work.
Labeling and review. The NIH Office of Dietary Supplements reports that vitamin K has no tolerable upper intake level because of its low potential for toxicity [3]. Label statements, including those on interaction with medicines that act on blood coagulation, are reviewed for each sales market before a product is developed.

Customization Options

Brands adjust the vitamin K2 amount, the menaquinone form, the format and the add-ons.

ParameterRangeNote
Vitamin K2 per serving45, 50, 90 or 100 mcgExamples for the brand; premix weight per unit scales with the amount
Menaquinone formMK-7 or MK-4Separate specifications; the form sets the raw material and the stability plan
FormatCapsule or softgelTablet, powder and gummy are separate projects
Pack size30 to 120 unitsSet by the brand
Add-onsVitamin D3, calcium, magnesiumA combination product moves the unit size and the vitamin uniformity plan

The pilot run confirms blend uniformity of the premix at microgram level, oil dissolution and shell behavior in the softgel, and the content assay of vitamin K2 in the first units against the labeled 100 mcg.

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (100 mcg on the label of CF011924; example DSLD labels 178234, 178235, 220581). The label names the ingredient as vitamin K2; menaquinone-7 is set as the form.
SpecificationSet in formulationMenaquinone-7 premix, 100 mcg vitamin K2 per serving; assay, premix dilution, isomer content and limits and method are fixed with the supplier. Unit size, fill weight and stability are set in formulation.
Data sourceNIH DSLDDSLD v9.4.0, downloaded 2026-01-10: 50,824 reference formulas merged from on-market labels with complete ingredient amounts. Counts show how labels are distributed.
Market reviewPer marketDose limits, labeling and claims are reviewed for each sales market before a finished product is developed.
ReferencesSources[1] Ma ML, Ma ZJ, He YL, et al. Efficacy of vitamin K2 in the prevention and treatment of postmenopausal osteoporosis: A systematic review and meta-analysis of randomized controlled trials. Front Public Health. 2022;10:979649. DOI · PubMed<br>[2] Mladěnka P, Macáková K, Kujovská Krčmová L, et al. Vitamin K – sources, physiological role, kinetics, deficiency, detection, therapeutic use, and toxicity. Nutr Rev. 2022;80(4):677-698. DOI · PubMed<br>[3] NIH Office of Dietary Supplements. Vitamin K: Fact Sheet for Health Professionals. Source

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