Red Yeast Rice Powder

Single-ingredient red yeast rice reference formula at 1,200 mg per serving, developed as a two-capsule serving or a tablet.

Red Yeast Rice is a reference formula for brands building a single-ingredient fermented rice product at a default amount of 1,200 mg of red yeast rice powder per serving. Red yeast rice is the only active ingredient, so the development work centers on the content of monacolin K, the control of the mycotoxin citrinin, and the regulatory status of a product whose active compound is also a pharmaceutical.

Capsule is the lead format, with the 1,200 mg serving built as two 600 mg capsules as on the reference label, and a tablet version uses a compression system. An option of 600 mg sits beside the default. Monacolin K content, citrinin limit and the legal category of the product differ by market, so the target market is chosen before pilot work starts.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
Red Yeast Rice1200 mg (default amount)Red yeast rice powder from rice fermented with Monascus purpureus, specified on monacolin K content and citrinin limit; 1,200 mg powder per servingA standardized red yeast rice extract at a smaller fill weight, or a low-monacolin or monacolin-free fermentation product, as separate specifications

Amounts are stated as mg of red yeast rice powder, not of monacolin K. Monacolin K is the core lipid-lowering component of the product [2], and the amount per serving equals the powder weight multiplied by its monacolin K assay, which differs widely between lots and suppliers. The assay, the free and lactone forms and the citrinin result are part of the specification.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around heart and circulatory nutrition. Red yeast rice is included as the single active so that the standardization, the amount and the excipient system can be set without interaction with other actives.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Traditional fermented food ingredientRed Yeast RiceIncluded because red yeast rice is a traditional fermented product of rice and Monascus purpureus with a millennia-long history of culinary and medicinal use in East Asia [2]. Evidence: Referenced
Lipid studiesRed Yeast RiceA meta-analysis of 20 randomized studies using red yeast rice with a known monacolin K content found LDL cholesterol lower by 1.02 mmol/L than placebo and not different from statin therapy, and described the quality of safety assessment as low in most studies [1]. Evidence: Mixed

The amount is one stated tier. The review in [1] concludes that red yeast rice might be a safe and effective option only if its mild adverse reaction profile is affirmed with adequate safety methods, so amount, claims and target market are brand decisions reviewed for each sales market.

Available Formats

The red yeast rice reference formula is built for a two-capsule version and a tablet version; counts per serving are design choices that the brand can adjust.

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Capsule2 capsules1200 mg120 capsules (60 servings)Gelatin shell, rice flour, silica, vegetable magnesium stearateLead format; mirrors the 2 x 600 mg reference serving
Tablet2 tablets1200 mg120 tablets (60 servings)Microcrystalline cellulose, croscarmellose sodium, stearic acid, film coatCompressed units that limit exposure of the powder

Raw Material Input & Fill (Design Estimate)

Design estimates. The input is the labeled powder weight at an assumed 100% assay of the powder as purchased, so 600 mg per unit and 1200 mg per serving are the inputs; the monacolin K content follows from the lot and is fixed in the specification.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Capsule600 mg per capsule (2 per serving)650 mg per capsule50 mgBulk density, fill weight variation, flow, monacolin K and citrinin assay
Tablet600 mg per tablet (2 per serving)800 mg tablet weight200 mgCompression behavior, hardness, disintegration, monacolin K and citrinin assay

Powder, softgel and gummy versions are separate projects, because a fermented rice powder with a variable active content needs its own homogeneity and stability work in those systems.

Formulation Considerations

Monacolin K content per lot. The powder is a fermentation product, and monacolin K varies between strains, fermentation conditions and lots. The specification names the monacolin K assay and tolerance, and each lot is released against it so that the content per serving is known.
Citrinin control. The review in [2] frames the central challenge as standardizing monacolin K while eliminating the nephrotoxic mycotoxin citrinin. A citrinin limit with a named method, a supplier whose strain and process control citrinin, and a certificate for every lot are written into the specification.
Regulatory category. Monacolin K is the same compound as a statin drug in its lactone form, and markets treat high-monacolin products differently, so the legal category and any limit on monacolin K per day are settled with the target market first.
Evidence and safety. The meta-analysis in [1] found no difference in liver and kidney injury between red yeast rice and control groups and judged safety assessment quality low. Label statements and the dose limit for each sales market are reviewed before a product is developed.

Customization Options

Brands adjust the powder weight, the monacolin K target, the format and the labeling.

ParameterRangeNote
Powder per serving600 or 1200 mgOptions for the brand; capsule count follows the chosen tier
Monacolin K targetSet with the supplier and the marketDrives the legal category and the label statement
Raw material formPowder, standardized extract or monacolin-free productSeparate specifications with different claims
FormatCapsule or tabletPowder, softgel and gummy are separate projects
Add-onsCoenzyme Q10, plant sterols, policosanolAnother active adds fill weight and a safety review of the combination

The pilot run confirms bulk density and fill weight of the powder, tablet hardness, and the monacolin K and citrinin results of the first units against the specification.

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (1200 mg on the label of CF000695, a two-capsule serving; example DSLD labels 4832, 21084, 21178). The label names the ingredient as red yeast rice powder; a Monascus purpureus fermented rice powder is set as the form.
SpecificationSet in formulationRed yeast rice powder, 1,200 mg per serving; monacolin K assay, citrinin limit, moisture, microbial, pesticide 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] Gerards MC, Terlou RJ, Yu H, et al. Traditional Chinese lipid-lowering agent red yeast rice results in significant LDL reduction but safety is uncertain – a systematic review and meta-analysis. Atherosclerosis. 2015;240(2):415-23. DOI · PubMed<br>[2] Chen X, Zheng M, Chen Q, et al. Research Progress, Safety Regulation and Application Prospects in Health Food Development of Red Yeast Rice-Derived Bioactive Compounds: A Critical Narrative Review. Foods. 2026;15(7):1146. DOI · PubMed

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