Vitamin B1

Single-ingredient vitamin B1 (thiamine) reference formula at 100 mg per serving, developed as a tablet or capsule.

Vitamin B1 is a reference formula for brands building a single-ingredient B-vitamin product at a default amount of 100 mg of thiamine per serving. Thiamine is the only active ingredient, so the development work centers on the thiamine salt, the weight of salt that carries 100 mg of thiamine, and moisture control for a water-soluble vitamin in a solid unit.

Tablet is the lead format because 100 mg of thiamine from the nitrate salt fits one small coated tablet, and a capsule version carries the same salt in a standard fill. Options of 150, 300 and 500 mg 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 B1100 mg (default amount)Thiamine mononitrate, specified on a thiamine basis; 100 mg vitamin B1 per servingThiamine hydrochloride, with the input recalculated to 100 mg of thiamine

Amounts are stated as mg of thiamine. Thiamine (cation, 265.36 g/mol; PubChem CID 1130) is 81.1% of thiamine mononitrate by weight (327.36 g/mol; CID 10762) and 78.7% of thiamine hydrochloride (337.3 g/mol; CID 6202), so 100 mg of thiamine needs about 123 mg of the nitrate or 127 mg of the hydrochloride. The label basis, thiamine or salt, is stated in the specification.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around daily vitamin B1 intake and energy nutrition. Thiamine is included as the single active so that the salt, the amount and the excipient system can be set without interaction with other actives.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Energy metabolism nutritionVitamin B1Included as an essential water-soluble vitamin that plays an important role in energy metabolism [1]. Evidence: Referenced
Thiamine statusVitamin B1A clinical review describes thiamine deficiency disorders as affecting the metabolic, neurologic, cardiovascular, respiratory, gastrointestinal and musculoskeletal systems, and calls for population-level surveillance and prevention programs [1]. Evidence: Referenced

The amount is one stated tier. The NIH Office of Dietary Supplements reports that no tolerable upper intake level has been set for thiamine because adverse effects have not been reported at intakes of 50 mg per day or more, while cautioning that excessive intakes could still have adverse effects [2]. Amount, claims and target market are brand decisions reviewed for each sales market.

Available Formats

The vitamin B1 reference formula is built for a tablet version and a capsule version; counts per serving are design choices that the brand can adjust.

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Tablet1 tablet100 mg60 or 100 tabletsDicalcium phosphate, vegetable cellulose, stearic acid, silica, vegetable magnesium stearateLead format; small coated unit
Capsule1 capsule100 mg60 or 90 capsulesCellulose, flow agent, vegetable capsule shellSalt in a standard fill

Raw Material Input & Fill (Design Estimate)

Design estimates. The input is the thiamine amount divided by the thiamine content of the salt at an assumed 100% assay: thiamine mononitrate at 81.1% gives about 123 mg of salt for 100 mg of thiamine, against about 127 mg of thiamine hydrochloride.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Tablet123 mg mononitrate250 mg tablet weight127 mgHardness, disintegration, coating integrity, content assay of thiamine
Capsule123 mg mononitrate220 mg per capsule97 mgFill weight variation, flow, moisture, content assay of thiamine

Powder, liquid and gummy versions are separate projects, because a water-soluble B vitamin in a dissolving or chewable system brings its own taste and stability work.

Formulation Considerations

Salt choice and thiamine yield. The mononitrate is the less hygroscopic salt and is the lead in this design, and the hydrochloride needs about 4 mg more per unit for the same thiamine. The salt is fixed with the supplier together with its assay.
Moisture and potency. Thiamine salts pick up moisture, and potency can fall with heat and humidity. A coated tablet, a barrier bottle and a desiccant are tested in stability work, and thiamine content through shelf life is measured by assay.
Label basis. The label amount is thiamine, not the salt. The specification states the thiamine assay of the raw material, and finished units are assayed as thiamine.
Amount tier. The reference amounts run from 100 to 500 mg per unit. The ODS notes the absence of an upper intake level and the lack of reports of adverse effects from 50 mg per day or more [2], and the dose limit for each sales market is still checked before a product is developed.

Customization Options

Brands adjust the amount per serving, the thiamine salt, the format and the add-ons.

ParameterRangeNote
Amount per serving100, 150, 300 or 500 mgOptions for the brand; unit size scales with the tier
Thiamine saltMononitrate or hydrochlorideThiamine percent differs by salt; input recalculated from the assay
FormatTablet or capsulePowder, liquid and gummy are separate projects
Pack size30 to 120 unitsSet by the brand
Add-onsVitamin B6, vitamin B12, benfotiamineA B-complex partner adds unit weight and a second assay to the release plan

The pilot run confirms tablet hardness and coating integrity, capsule fill weight and flow, moisture behavior of the salt, and the content assay of thiamine in the first units against the labeled amount.

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (100 mg on the label of CF000023; example DSLD labels 590, 4342, 6095). The label names the ingredient as vitamin B1; thiamine mononitrate is set as the form.
SpecificationSet in formulationThiamine mononitrate, 100 mg thiamine per serving; assay, water content and impurity 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] Smith TJ, Johnson CR, Koshy R, et al. Thiamine deficiency disorders: a clinical perspective. Ann N Y Acad Sci. 2021;1498(1):9-28. DOI · PubMed<br>[2] NIH Office of Dietary Supplements. Thiamin: Fact Sheet for Health Professionals. Source

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