Black Cohosh Root Powder

Single-ingredient black cohosh reference formula with 540 mg per serving, developed as a capsule, with a tablet option.

Black Cohosh Root Powder is a reference formula for brands building a single-ingredient botanical product with an example amount of 540 mg of black cohosh per serving. Black cohosh is the only active, so the development work centers on the plant part and form of the raw material, the triterpene glycoside standardization of an extract, and the capsule or tablet system that carries it.

Capsule is the lead format because 540 mg of root powder fits a large capsule or two standard ones, with a tablet for brands that prefer a compressed unit. The reference labels span amounts from 13.5 mg to 966 mg and mix root powders with extracts, so the page is built around black cohosh root with an extract grade as the alternative.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
Black Cohosh540 mg (example amount)Black cohosh root and rhizome powder; specification 540 mg per serving, plant identity, particle size and moisture set with the supplierBlack Cohosh Extract 2.5–8% Triterpene Glycosides or general Black Cohosh Extract Powder, each with its own input weight

Amounts are stated as mg of black cohosh material, not of any marker compound. At the same label weight an extract carries far more triterpene glycosides than a root powder: 540 mg of a 2.5% extract carries about 13.5 mg and 540 mg of an 8% extract about 43.2 mg, so the form and grade are part of the specification.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around midlife women’s wellness nutrition. Black cohosh is included as the single active so that the form, the amount and the excipient system can be set without interaction with other actives.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Midlife women’s nutritionBlack CohoshAn updated pairwise meta-analysis of 22 articles with 2,310 menopausal women reported that black cohosh extracts, alone or combined with other active ingredients, were associated with significant improvements in overall menopausal symptoms (Hedges’ g 0.575, 95% CI 0.283–0.867) [1]. Evidence: Referenced

The studies behind [1] used extracts alone or combined with other ingredients, so amount, claims and target market for a finished product are brand decisions reviewed for each sales market.

Available Formats

The black cohosh 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 capsule540 mg60 or 120 capsulesRice flour, flow agent, vegetable capsule shellLead format; a large capsule holds the full serving
Tablet1 tablet540 mg60 or 90 tabletsMicrocrystalline cellulose, binder, disintegrant, film coatingCompressed unit; fibrous root powder needs granulation

Raw Material Input & Fill (Design Estimate)

Design estimates. The input is the labeled black cohosh weight at an assumed 100% of the powder as purchased, so each unit uses the weight shown below; the real input follows the certificate of analysis.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Capsule540 mg root powder600 mg per capsule60 mgDensity of the blend, fill weight spread, flow, moisture
Tablet540 mg root powder800 mg per tablet260 mgHardness, disintegration, friability, coating adhesion

Powder, softgel and liquid versions are separate projects, because a fibrous root powder and a tincture or liquid extract need their own dosing and taste work.

Formulation Considerations

Plant identity. Black cohosh root is told apart from related species by identity testing, and the specification names the species, the plant part and the identity method before any lot is accepted.
Root powder or extract. A 540 mg root powder and a 540 mg extract are different products. The reference labels pool both under one name, so the form is fixed in the specification and the triterpene glycoside content is stated for an extract.
Bulky fibrous powder. Root powder is bulky and takes up moisture, so capsule size, powder density, humidity control and granulation for tablets are set early, and a 540 mg fill uses most of a large capsule.
Safety and tier. Case reports describe liver injury associated with black cohosh, including a case that led to liver transplantation [2], so label wording, warnings and the target market are reviewed before development. Review of the dose limit and label wording for each sales market precedes product development.

Customization Options

Brands adjust the black cohosh amount, the form and grade, the format and the add-ons.

ParameterRangeNote
Black cohosh per serving40, 125, 540 or 1000 mgExamples for the brand; the smaller amounts suit an extract and the larger ones a root powder
Form and gradeRoot powder, extract powder or 2.5–8% triterpene glycoside extractChanges the input weight and the specification
FormatCapsule or tabletPowder, softgel and liquid are separate projects
Pack size60 to 120 unitsSet by the brand
Add-onsSoy isoflavones, vitamin B6Soy isoflavones add a second plant source and fill weight, and vitamin B6 is a small-dose add-on

The pilot run confirms powder density and fill weight, tablet hardness and disintegration with the chosen binder, and the assay 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 (540 mg on the label of CF003277; example DSLD labels 20996, 36511, 39986). The label names the ingredient as black cohosh; a root and rhizome powder is set as the form.
SpecificationSet in formulationBlack cohosh root and rhizome powder, 540 mg per serving; species, plant part, identity method, moisture, pesticide and heavy-metal limits 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] Sadahiro R, Matsuoka LN, Zeng BS, et al. Black cohosh extracts in women with menopausal symptoms: an updated pairwise meta-analysis. Menopause. 2023;30(7):766-773. DOI · PubMed<br>[2] Lim TY, Considine A, Quaglia A, Shawcross DL. Subacute liver failure secondary to black cohosh leading to liver transplantation. BMJ Case Rep. 2013;2013:bcr2013009325. DOI · PubMed

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