Vitamin B12

Single-ingredient vitamin B12 reference formula at 1 mg (1,000 mcg) per serving, developed as a tablet, lozenge or liquid.

Vitamin B12 is a reference formula for brands creating a single-ingredient cobalamin product at a default amount of 1 mg (1,000 mcg). The formula carries one cobalamin as its only active, so the work lies in choosing the cobalamin compound and in spreading a milligram-level amount of an intensely colored active through each unit.

The default amount is 1 mg (1,000 mcg) per serving. Tablet is the lead format, with a lozenge (a dissolvable unit) and a liquid as the two companion formats for brands that want a dissolvable or dropper option.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
Vitamin B121 mg (default amount)Cyanocobalamin, supplied as a diluted trituration or premix for tablets and lozenges and as crystalline powder for liquids; specification 1 mg (1,000 mcg) cyanocobalamin per servingMethylcobalamin, set at the same 1,000 mcg per serving as a separate compound; other cobalamins are raw material discussions with the supplier

Amounts are stated as mg of cobalamin as the compound named on the label; DSLD stores the amount in mg, so 1 mg is 1,000 mcg and 500 mcg is 0.5 mg. Cyanocobalamin is C63H88CoN14O14P at 1355.4 g/mol (PubChem CID 166596686) and methylcobalamin is C63H91CoN13O14P at 1344.4 g/mol (PubChem CID 10898559). They are different compounds rather than salts of one another, so amounts are listed as printed and are not converted between them.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around B12 intake in energy-related nutrition and for plant-based diets. Vitamin B12 is the single active so that the cobalamin compound and the amount can be set without interaction with other actives.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Energy-related nutritionVitamin B12Cobalamin acts as a cofactor in one-carbon transfers through methylation and in fatty acid, amino acid and nucleic acid metabolic pathways [2]. Evidence: Referenced
Plant-based diet nutritionVitamin B12Cobalamin is poorly represented in plant foods [2], and a nutrition biomarker review notes a high prevalence of B12 insufficiency in populations eating low amounts of animal-source foods [1]. Evidence: Referenced

The tier (500 mcg to 5 mg) is a decision for the brand and its target market, and dose limits are reviewed for each sales market.

Available Formats

Three formats can be developed from this reference formula, each at one unit or one measured dose per serving. The brand sets the final pack counts; the figures here are opening suggestions.

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Tablet1 tablet1 mg (1,000 mcg)60 or 100 tabletsDicalcium phosphate, mannitol, cellulose, croscarmellose, stearic acid, silica, magnesium stearateLead format; compact unit from a diluted premix
Other (lozenge)1 lozenge1 mg (1,000 mcg)60 lozengesMannitol, sweetener, flavor, acidulant, lubricantDissolvable unit
Liquid1 mL1 mg (1,000 mcg)30 mL dropper bottleWater, glycerin, sweetener, flavor, preservative, acidulantDropper format with a soluble cobalamin

Raw Material Input & Fill (Design Estimate)

Design estimates. The input for tablets and lozenges assumes a 1% cyanocobalamin premix (10 mg of cyanocobalamin per g), so 1 mg needs 100 mg of premix; the liquid assumes crystalline cyanocobalamin at 100% assay.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Tablet100 mg premix250 mg tablet weight150 mgBlend uniformity, color spotting, hardness, content assay
Other (lozenge)100 mg premix800 mg lozenge weight700 mgBlend uniformity, dissolution time, content assay
Liquid1 mg cyanocobalamin per mL1000 mg (1 mL)999 mgDissolved content, preservative system, pH, content assay

Gummy, capsule and softgel versions are separate projects, because each needs its own matrix or carrier for a milligram-level cobalamin amount.

Formulation Considerations

Choice of cobalamin. Cyanocobalamin and methylcobalamin are separate compounds with different molecular weights (1355.4 and 1344.4 g/mol), so the label amount, the raw material specification and the supplier documentation are all tied to the compound chosen. The compound is fixed before the pilot run, not changed afterward.
Color and uniformity. Cobalamins are deep red, so a poorly mixed premix shows as speckles in a white tablet or lozenge. At 100 mg of premix in a 250 mg tablet the active is spread through 40% of the unit weight as premix, and blend uniformity and a visual check for color spots are part of the first-batch plan.
Dissolvable formats. For the lozenge the questions are dissolution time and taste of the base, and for the liquid they are dissolved content, pH and the preservative system over shelf life. Both formats are tested for content over time, not only at release.
Amount tier and market. Brands choose among amounts from 500 mcg to 5 mg. Whichever tier is chosen, dose limits and label wording are checked for each sales market before launch.

Customization Options

Brands adjust the amount per serving, the cobalamin compound, the format and the flavor.

ParameterRangeNote
Amount per serving500 mcg, 1 mg, 2.5 mg or 5 mgOptions for the brand; premix input changes with the tier
Cobalamin compoundCyanocobalamin or methylcobalaminSeparate compounds with separate specifications
FormatTablet, lozenge or liquidGummy, capsule and softgel are separate projects
Pack size30 to 100 unitsSet by the brand
Add-onsFolate, vitamin B6, ironEach addition changes the blend and the color plan and is a separate project

The pilot run confirms blend uniformity and color of the red premix, the content assay of the first units against the labeled 1 mg, and, for liquids, content stability across the preservative system.

Flavor Options

FormatSuggested FlavorsWhy
Other (lozenge)Cherry, berry, mintFruit and mint profiles suit a dissolvable unit and cover the base taste
LiquidBerry, citrusFruit profiles mask the sweetener and preservative taste in a dropper format

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (1 mg on the label of CF008112; example DSLD labels 60380, 62744, 62896). The label names the ingredient as vitamin B12; cyanocobalamin is set as the form.
SpecificationSet in formulationCyanocobalamin, 1 mg (1,000 mcg) per serving; assay limits, purity 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] Allen LH, Miller JW, de Groot L, et al. Biomarkers of Nutrition for Development (BOND): vitamin B-12 review. J Nutr. 2018;148(suppl_4):1995S–2027S. DOI · PubMed<br>[2] Rizzo G, Laganà AS, Rapisarda AM, et al. Vitamin B12 among vegetarians: status, assessment and supplementation. Nutrients. 2016;8(12):767. DOI · PubMed

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