Usp requirements for mushroom extract
By Jake, founder · Published · Updated
usp sets 19 requirements for mushroom extract: 12 with a numeric limit, 4 documentary (a record must be on file or a property absent), 14 advisory (no authoritative number exists), each carrying its primary-source citation below, last verified 2026-07-24.
The requirements
| Requirement | Category | Limit | Unit | Basis | Method | Status | Source |
|---|---|---|---|---|---|---|---|
| Arsenic, inorganic (As)arsenic_inorganic | heavy metals | ≤ 15 | µg/day | per day | n/a | Mandatory | USP <2232> Elemental Contaminants in Dietary Supplements, Table 1 (Permitted Daily Exposure)verified 2026-07-24 |
| Cadmium (Cd)cadmium | heavy metals | ≤ 5 | µg/day | per day | n/a | Mandatory | USP <2232> Elemental Contaminants in Dietary Supplements, Table 1 (Permitted Daily Exposure)verified 2026-07-24 |
| Lead (Pb)lead | heavy metals | ≤ 10 | µg/day | per day | n/a | Mandatory | USP <2232> Elemental Contaminants in Dietary Supplements, Table 1 (Permitted Daily Exposure)verified 2026-07-24 |
| Mercury, total (Hg)mercury_total | heavy metals | ≤ 15 | µg/day | per day | n/a | Mandatory | USP <2232> Elemental Contaminants in Dietary Supplements, Table 1 (Permitted Daily Exposure)verified 2026-07-24 |
| Methylmercury (as Hg)methylmercury | heavy metals | ≤ 2 | µg/day | per day | n/a | Mandatory | USP <2232> Elemental Contaminants in Dietary Supplements, Table 1 (Permitted Daily Exposure)verified 2026-07-24 |
| Arsenic, inorganic (As) — individual component limitarsenic_inorganic | heavy metals | ≤ 1.5 | µg/g | per gram | n/a | Advisory | USP <2232> Table 2 (Individual Component Limits; valid only at max daily intake at or below the stated basis)verified 2026-07-24 |
| Cadmium (Cd) — individual component limitcadmium | heavy metals | ≤ 0.5 | µg/g | per gram | n/a | Advisory | USP <2232> Table 2 (Individual Component Limits; valid only at max daily intake at or below the stated basis)verified 2026-07-24 |
| Lead (Pb) — individual component limitlead | heavy metals | ≤ 1 | µg/g | per gram | n/a | Advisory | USP <2232> Table 2 (Individual Component Limits; valid only at max daily intake at or below the stated basis)verified 2026-07-24 |
| Mercury, total (Hg) — individual component limitmercury_total | heavy metals | ≤ 1.5 | µg/g | per gram | n/a | Advisory | USP <2232> Table 2 (Individual Component Limits; valid only at max daily intake at or below the stated basis)verified 2026-07-24 |
| Methylmercury (as Hg) — individual component limitmethylmercury | heavy metals | ≤ 0.2 | µg/g | per gram | n/a | Advisory | USP <2232> Table 2 (Individual Component Limits; valid only at max daily intake at or below the stated basis)verified 2026-07-24 |
| Total Aerobic Microbial Count (TAMC)total_aerobic_microbial_count | microbial | ≤ 10000 | cfu/g | per gram | n/a | Advisory | USP <2023> Microbiological Attributes of Nonsterile Nutritional and Dietary Supplements, USP <2023> Table 2verified 2026-07-24 |
| Total Combined Yeasts & Moulds Count (TYMC)total_yeast_mould_count | microbial | ≤ 1000 | cfu/g | per gram | n/a | Advisory | USP <2023> Microbiological Attributes of Nonsterile Nutritional and Dietary Supplements, USP <2023> Table 2verified 2026-07-24 |
| Salmonella speciessalmonella | microbial | absent | per 10 g | n/a | n/a | Advisory | USP <2023> USP <2023> Table 2 (absence of specified microorganisms), method USP <2022>verified 2026-07-24 |
| Escherichia colie_coli | microbial | absent | per 10 g | n/a | n/a | Advisory | USP <2023> USP <2023> Table 2 (absence of specified microorganisms), method USP <2022>verified 2026-07-24 |
| Staphylococcus aureuss_aureus | microbial | absent | per 10 g | n/a | n/a | Advisory | USP <2022> (not in the general USP <2023> category tables)verified 2026-07-24 |
| Clostridiaclostridia | microbial | absent | per 10 g | n/a | n/a | Advisory | USP <2022> (not in the general USP <2023> category tables)verified 2026-07-24 |
| Pesticide residues (panel varies by input)pesticide_residues | pesticide | n/a | n/a | n/a | n/a | Advisory | USP <561> Articles of Botanical Origin; EPA tolerances, 40 CFR 180verified 2026-07-24 |
| Residual solvents (extraction solvents)residual_solvents | residual solvent | n/a | n/a | n/a | n/a | Advisory | USP <467> Residual Solventsverified 2026-07-24 |
| Aflatoxins / mycotoxinsaflatoxins | pesticide | n/a | n/a | n/a | n/a | Advisory | USP <561> / USP <2023> (botanicals with mycotoxin history)verified 2026-07-24 |
Advisory rows have no authoritative published number, so no value is invented for them. Per-day bases convert to a concentration limit only with a specific product's serving size, so no bare concentration is stated here.
Who is responsible
The brand owner, even when manufacturing is contracted out. A quality agreement can allocate who performs each task; it cannot transfer the responsibility for a correctly documented product that meets these requirements. In practice: the manufacturer runs the tests and holds the records, and the brand must be able to produce them, current and complete, when a platform, retailer, or inspector asks.
What a certificate of analysis (COA) needs to show to clear this review
A COA that clears review against this table has, at minimum:
- Laboratory identity with contact details and an accreditation reference: verifiers contact the issuing lab to confirm authenticity.
- Sample identification: product name and lot code matching the batch, with report, manufacture, and expiry dates that agree with each other.
- One row per requirement above: the analyte as tested, the numeric result with its unit, the method, and the lab's own specification. “Conforms” without a number is not a result a reviewer can accept.
- Detection limits on non-detects: “ND” only demonstrates compliance when the method's detection limit is at or below the required limit.
- Current date: verification programmes cap document age; an expired COA is unusable regardless of its content.
Common questions
- Who is responsible for meeting usp requirements?
- The brand owner. Responsibility for individual tasks can be allocated to a contract manufacturer through a quality agreement, but the responsibility for a correctly documented product that meets these requirements cannot be contracted out. The manufacturer holds the records; the brand holds the liability.
- Where do these values come from?
- Every row carries its own primary-source citation and the date it was last verified (2026-07-24). Nothing on this page is estimated: values marked advisory have no authoritative published number, and no number is invented for them.
- What happens when a value changes?
- The dataset is versioned. When a set is superseded, this page regenerates with the new values and the update date changes, and customers with affected SKUs are told what changed and what is now needed.
- How do I know if my current documents meet these requirements?
- Upload them to the free gap check. It reads each document, compares every extracted value against this table, and names what is missing, with the citation, before any reviewer does.
Would your documents pass against this table?
The agent reads your mushroom extract label or test report against these rows, compares every value, and names what is missing with the citation. Get in touch and we will take you through it on a document of yours.