N-Acetylcysteine

N-acetylcysteine (NAC) reference formula at a default of 600 mg per serving, developed as a capsule or powder.

N-Acetylcysteine is a reference formula for brands building a single-ingredient NAC product around 600 mg per serving. The brand sets the final amount for its market.

Capsule is the lead format because most reference labels use it, with a powder version developed for brands that prefer a stick pack. The work centers on a sulfur-containing amino acid derivative: its odor, its tendency to oxidize and its hygroscopic powder shape the antioxidant system, the pack and the taste work.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
N-Acetylcysteine600 mgN-acetyl-L-cysteine powder, specified on a declared-weight basis; 600 mg per servingA coated or granulated NAC grade, or a related form such as N-acetylcysteine amide, which is a different compound with its own specification

The amount is stated as mg of N-acetyl-L-cysteine. N-acetyl-L-cysteine is C5H9NO3S, 163.20 g/mol (PubChem CID 12035); the free form has no salt or hydrate conversion. Reference labels write the name as N-acetylcysteine or as N-acetyl L-cysteine, and the page treats them as the same ingredient.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around amino acid antioxidant nutrition. NAC is included as the single ingredient so that the concept stays on one cysteine derivative.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Glutathione precursorN-AcetylcysteineA review describes NAC as the N-acetyl derivative of the amino acid L-cysteine whose antioxidant effect is due to its ability to act as a reduced glutathione precursor, and states that its disulphide-breaking activity also explains its mucolytic activity [1]. Evidence: Referenced
Mechanism of actionN-AcetylcysteineA second review states that conventional assumptions about NAC, such as acting as a reductant, a scavenger or a glutathione precursor, cannot be generalized to explain its effects in most settings, and that conversion into hydrogen sulfide and sulfane sulfur species is a newly discovered mechanism [2]. Evidence: Mixed

The amount is a design choice. The reviews in [1] and [2] describe NAC mechanisms in general and do not test this formula, and NAC is also used as a medicine in some markets, so the classification of a finished product and any claim are reviewed for each market.

Available Formats

Reference labels are mostly capsules, with powders and tablets behind them; capsule and powder are developed here.

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Capsule1 capsuleN-acetylcysteine 600 mg60 or 120 capsulesVegetarian capsule shell (cellulose), ascorbyl palmitateLead format; one capsule per serving
Powder1 stick pack, 3 gN-acetylcysteine 600 mg30 stick packsSweetener, acid, flavor, flow agentDissolves into a drink; odor and taste need masking

Raw Material Input & Fill (Design Estimate)

Design estimates. N-acetylcysteine is assumed at 100% of its declared weight, so 600 mg per serving needs 600 mg of raw material; the supplier’s assay is applied once the lot is chosen.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Capsule600 mg640 mg per capsule40 mgFill volume against the size 00 capsule, weight spread, shell opening time, assay after a humidity hold
Powder600 mg3 g per stick pack2,400 mgDissolution, sulfur odor in the sachet and in the drink, stability of the assay

Tablet, liquid and gummy are separate projects, because NAC at this level changes compression, odor and stability work in those systems.

Formulation Considerations

Sulfur odor. NAC has a noticeable sulfur smell that is stronger in an open pack and in solution. Capsules keep it inside the unit, while a powder needs sachet barrier material and a flavor system that is tested in the pilot run.
Oxidation and moisture. The thiol group oxidizes over time and the powder takes up moisture, so a desiccant, an oxygen-barrier pack and an antioxidant such as ascorbyl palmitate are part of the plan. The assay tracks NAC and its oxidized dimer.
Capsule volume. 600 mg of NAC fills most of a size 00 capsule, which leaves little room for excipients; a denser grade or a two-capsule serving is the fallback.
Product classification. A review notes that NAC is used as a mucolytic and as the standard of care for paracetamol intoxication, and is on the World Health Organization’s list of essential medicines [2]. Whether NAC is sold as a food supplement depends on the market, and this is settled in the market review before a formula is finalized.

Customization Options

Brands choose the NAC grade and the amount first, then the format and the add-ons.

ParameterRangeNote
NAC per serving500, 600 or 1000 mgExamples for the brand; the allowed amount depends on the market
GradeStandard powder, coated or granulatedChanges flow, odor and moisture behavior
FormatCapsule or powderTablet, liquid and gummy are separate projects
Add-onsVitamin C, selenium, glycineA second ingredient changes the unit weight and the claim wording

The pilot run confirms the NAC assay after a humidity hold, capsule fill against the chosen lot, and the odor of the stick pack.

Flavor Options

FormatSuggested FlavorsWhy
PowderOrange, lemon, berryStrong fruit flavors cover the sulfur note

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 CF000439; example DSLD labels 2958, 6392, 11797). The label names the ingredient as N-acetylcysteine; the free form is set.
SpecificationSet in formulationN-acetyl-L-cysteine free form at 600 mg per serving; assay, specific rotation, oxidized dimer, moisture, microbial and heavy-metal 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] Aldini G, Altomare A, Baron G, et al. N-Acetylcysteine as an antioxidant and disulphide breaking agent: the reasons why. Free Radic Res. 2018;52(7):751-762. DOI · PubMed<br>[2] Pedre B, Barayeu U, Ezeriņa D, et al. The mechanism of action of N-acetylcysteine (NAC): The emerging role of H2S and sulfane sulfur species. Pharmacol Ther. 2021;228:107916. DOI · PubMed

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