L-Lysine

Single-ingredient L-lysine reference formula at 500 mg per serving, developed as a capsule or tablet, with a 1,000 mg tablet option.

L-Lysine is a reference formula for brands building a single-ingredient amino acid product at a default amount of 500 mg of lysine per serving. L-lysine is the only active ingredient, so the development work centers on the lysine salt, the weight of salt that carries 500 mg of lysine, and the size of the unit that holds it.

Capsule is the lead format because 500 mg of lysine from the hydrochloride salt fits a single large capsule, while the tablet is built around a 1,000 mg serving for brands that want a larger amount per unit. The amount and the label wording are decisions for the brand and its market review.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
L-Lysine500 mg (default amount)L-lysine hydrochloride, specified on a lysine basis; 500 mg lysine per servingL-lysine free base or another salt, with the input recalculated to 500 mg of lysine

Amounts are stated as mg of lysine. L-lysine is C6H14N2O2, 146.19 g/mol (PubChem CID 5962); L-lysine hydrochloride is C6H15ClN2O2, 182.65 g/mol (CID 69568) and is 80.0% lysine by weight, so 500 mg of lysine needs about 625 mg of the salt. The label basis, lysine or lysine hydrochloride, is stated in the specification.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around daily amino acid intake and immune nutrition. L-lysine is included as the single active so that the salt, the amount and the unit size can be set without interaction with other actives.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Daily amino acid intakeL-LysineIncluded as an amino acid, one of the building blocks of proteins and polypeptides, within a balance among amino acids in the diet that a review describes as crucial for whole-body homeostasis [2]. Evidence: Referenced
Herpes simplex studiesL-LysineA review of lysine trials concluded that supplementation appears ineffective at doses below 1 g per day without low-arginine diets, that doses above 3 g per day appear to improve patients’ subjective experience, and that longer controlled studies are required [1]. Evidence: Mixed

One salt at one stated amount keeps the capsule specification simple. The review in [1] separates results below and above 1 g per day, so the amount tier, the claims and the target market stay brand decisions reviewed per market.

Available Formats

The lysine 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 capsule500 mg90 or 120 capsulesCellulose, magnesium stearate, capsule shellLead format; single large capsule
Tablet1 tablet1000 mg60 or 100 tabletsCellulose, binder, disintegrant, lubricant, coatingLarger compressed unit for the 1,000 mg option

Raw Material Input & Fill (Design Estimate)

Design estimates. The input is the lysine amount divided by the lysine content of the salt at an assumed 100% assay: L-lysine hydrochloride at 80.0% lysine gives 625 mg of salt for 500 mg of lysine, and 1,250 mg for the 1,000 mg tablet.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Capsule625 mg690 mg per capsule65 mgFill weight variation, flow, content assay of lysine
Tablet1250 mg1450 mg tablet weight200 mgCompression behavior, hardness, disintegration, content assay of lysine

Powder and gummy versions are separate projects, because a salt load of this size and the taste of an amino acid hydrochloride need their own work in a dissolving or chewable format.

Formulation Considerations

Salt weight versus lysine weight. Each 500 mg of lysine arrives with about 125 mg of hydrochloride, so the capsule is filled mostly with the salt. The capsule size, the fill weight and the label basis are fixed together with the supplier assay.
Large single unit. At 625 mg of salt in a 690 mg design fill, the capsule has little room for flow agents. A glidant level and powder density are set in sampling, and a two-capsule serving is the fallback.
Amount tier and evidence. The herpes simplex review in [1] reports results that differ below and above 1 g per day, and it advises caution for people with cardiovascular or gallbladder disease because of theoretical risks of lysine supplementation. Label statements and the dose limit for each sales market are reviewed before a product is developed.
Hygroscopic salt. Amino acid hydrochlorides pick up moisture, so blending humidity and pack barrier are set to limit caking in the bottle.

Customization Options

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

ParameterRangeNote
Amount per serving500, 750, 1000 or 1500 mg lysineOptions for the brand; capsule count or tablet size changes with the tier
Lysine saltHydrochloride or free baseInput recalculated to lysine; the salt adds about 25% weight
FormatCapsule or tabletPowder and gummy are separate projects
Pack size60 to 120 unitsSet by the brand
Add-onsVitamin C, zincA second active reshapes the fill weight and the specification

The pilot run confirms capsule fill weight and flow at the salt load, tablet hardness and disintegration in the 1,000 mg version, moisture behavior of the blend, and the content assay of the first units against the labeled amount of lysine.

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (500 mg on the label of CF000890; example DSLD labels 6399, 9630, 11773). The label names the ingredient as L-lysine; L-lysine hydrochloride is set as the form.
SpecificationSet in formulationL-lysine hydrochloride, 500 mg lysine per serving; assay, residue 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] Mailoo VJ, Rampes S. Lysine for Herpes Simplex Prophylaxis: A Review of the Evidence. Integr Med (Encinitas). 2017;16(3):42-46. PubMed<br>[2] Wu G. Amino acids: metabolism, functions, and nutrition. Amino Acids. 2009;37(1):1-17. DOI · PubMed

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