Alpha-Lipoic Acid

Single-ingredient alpha-lipoic acid reference formula at 600 mg per serving, developed as a capsule or tablet.

Alpha-Lipoic Acid is a reference formula for brands building a single-ingredient sulfur-containing antioxidant product at a default amount of 600 mg per serving. Alpha-lipoic acid is the only active ingredient, so the development work centers on a high-load active in a single unit: the capsule or tablet size, the odor of a sulfur compound, and the choice between a racemic grade and a single-enantiomer grade.

Capsule is the lead format because 600 mg of powder fits one large capsule, while the tablet carries the same active in a compression system with a coating. Amounts of 100, 200 and 300 mg sit beside the default for brands that want a smaller unit.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
Alpha-Lipoic Acid600 mg (default amount)Alpha-lipoic acid, racemic powder (thioctic acid); specification 600 mg alpha-lipoic acid per servingR-alpha-lipoic acid or its stabilized salt as a separate specification, with the input recalculated to the declared active

Amounts are stated as mg of alpha-lipoic acid (C8H14O2S2, 206.3 g/mol; PubChem CID 864). Alpha-lipoic acid is the free acid, so no salt conversion applies to the lead form; the enantiomer and any salt are set in the specification with the supplier.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around antioxidant nutrition and healthy aging. Alpha-lipoic acid is included as the single active so that the grade, the amount and the excipient system can be set without interaction with other actives.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Antioxidant nutritionAlpha-Lipoic AcidIncluded because a meta-analysis describes alpha-lipoic acid as acting through lower oxidative stress and better microcirculation in diabetic sensorimotor polyneuropathy [2]. Evidence: Referenced
Diabetic neuropathy studiesAlpha-Lipoic AcidA Cochrane review of 3 trials found little or no effect on neuropathy symptoms at six months with moderate-certainty evidence [1], while a meta-analysis of 10 trials reported favorable total symptom scores with a dose-related trend and no favorable result for nerve conduction results [2]. Evidence: Mixed

One grade at one stated amount keeps the specification short. The two reviews differ on what the amount does in patients, so the amount, the claims and the target market stay brand decisions reviewed per market.

Available Formats

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

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Capsule1 capsule600 mg60 or 90 capsulesMicrocrystalline cellulose, magnesium stearate, silicon dioxide, gelatin or vegetable shellLead format; large single capsule
Tablet1 tablet600 mg60 or 100 tabletsCellulose, binder, disintegrant, lubricant, coatingCompressed unit with a film coat

Raw Material Input & Fill (Design Estimate)

Design estimates. The input is the labeled amount divided by the assumed assay of the raw material, taken at 100% alpha-lipoic acid, so 600 mg needs 600 mg of raw material per serving.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Capsule600 mg700 mg per capsule100 mgFill weight variation, flow, odor, content assay
Tablet600 mg800 mg tablet weight200 mgCompression behavior, hardness, disintegration, content assay

Powder, softgel and gummy versions are separate projects, because the odor and low melting behavior of the active need their own handling in those systems.

Formulation Considerations

High load in one unit. At 600 mg of active in a 700 mg design capsule, the active is most of the fill. Capsule size, powder density and flow decide whether one capsule holds the amount, and a split into two capsules is the fallback.
Sulfur odor. Alpha-lipoic acid is a sulfur compound with a noticeable odor. A coated tablet or a sealed capsule shell contains it, and odor of the opened bottle is checked in the pilot run.
Racemic or single enantiomer. The reference labels name alpha-lipoic acid without stating the enantiomer. The specification states the enantiomer and the assay on the formula, because the grade changes the cost per milligram and the input weight.
Evidence and amount tier. The Cochrane review in [1] found little or no effect on symptoms in diabetic neuropathy, while the meta-analysis in [2] reports a dose-related trend at 600, 1200 and 1800 mg per day. The amount tier is therefore a decision for the brand and its target market, and the dose limit for each sales market is reviewed before a product is developed.

Customization Options

Brands adjust the amount per serving, the enantiomer grade, the format and the coating.

ParameterRangeNote
Amount per serving100, 200, 300 or 600 mgOptions for the brand; capsule size or tablet weight scales with the tier
GradeRacemic or R-enantiomerInput weight and cost per milligram differ by grade
FormatCapsule or tabletPowder, softgel and gummy are separate projects
CoatingNone, film coat or entericSets odor control and release behavior of the tablet
Add-onsBiotin, vitamin B complex, chromiumA second active reshapes the fill weight and the specification

The pilot run confirms capsule fill weight and flow at the high load, odor of the first units, tablet hardness and coating adhesion, and the content assay against the labeled 600 mg.

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (600 mg on the label of CF000225; example DSLD labels 1481, 21663, 33920). The label names the ingredient as alpha-lipoic acid; the racemic free acid is set as the form.
SpecificationSet in formulationAlpha-lipoic acid, racemic, 600 mg per serving; assay, enantiomer, 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] Baicus C, Purcarea A, von Elm E, et al. Alpha-lipoic acid for diabetic peripheral neuropathy. Cochrane Database Syst Rev. 2024;1(1):CD012967. DOI · PubMed<br>[2] Hsieh RY, Huang IC, Chen C, et al. Effects of Oral Alpha-Lipoic Acid Treatment on Diabetic Polyneuropathy: A Meta-Analysis and Systematic Review. Nutrients. 2023;15(16):3634. DOI · PubMed

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