KSM-66
ashwagandha root extract (Withania somnifera)
AshwagandhaSources last checked: July 11, 2026
Medical & Industry Advisor: Dr. James Pendleton, ND
Answer
Availability
We have not verified a current supply status for this ingredient. Unknown is our default: we publish a status only with dated evidence. If you have first-hand sourcing information, use the correction link below.
Owner and access
- Owner
- Ixoreal Biomed (site)
- Access model
- Licensed program
What it is
- Full-spectrum ashwagandha root extract from Ixoreal Biomed; logo rights are limited to licensed manufacturers. Note: the brand's own websites were unreachable or under reconstruction at review time; attribution verified via industry listing. [Ingredients Network supplier listing]
Spec parameters buyers should demand
What to ask for on the certificate of analysis and spec sheet. Identity, quality, and regulatory parameters only. This is not advice about efficacy.
| Parameter | What to ask | Why it matters |
|---|---|---|
| Withanolide content (standardization) | Request the certificate of analysis stating total withanolide content and the HPLC method. Confirm which marker set the CoA reports — total withanolides versus withanolide glycosides — because ashwagandha brands standardize to different markers. The USP Ashwagandha Root Dry Extract monograph sets a floor of not less than 2.5% withanolides.[USP Ashwagandha Root Dry Extract monograph] | The withanolide figure is the standardization number the material rests on, and knowing the marker set makes results comparable across suppliers. |
| Identity and species verification | Confirm the manufacturer runs at least one validated identity test on each incoming lot and documents the botanical species (Withania somnifera), as 21 CFR 111.75(a)(1) requires for every dietary ingredient unless FDA has granted a petition exemption.[21 CFR 111.75(a)(1) — identity test required for each dietary ingredient] | Identity testing is a federal manufacturing requirement, and a named species and method are what your quality file needs. |
| Plant-part authentication (root vs leaf/stem) | Ask the CoA to confirm the material is root-derived and document how undeclared leaf or stem material is screened out. The Botanical Adulterants Prevention Program identifies undeclared leaf/stem substituted into ashwagandha root products.[ABC-AHP-NCNPR Botanical Adulterants Prevention Program — Ashwagandha Root and Root Extract Bulletin] | Leaf and stem carry a different withanolide profile than root, so plant-part authentication is a defining quality attribute for a root extract. |
| Contaminants (heavy metals and aflatoxin) | Request heavy-metal results (lead, arsenic, cadmium, mercury) and aflatoxin results with methods and limits. The KSM-66 quality program documents heavy-metal and aflatoxin testing.[ksm66ashwagandhaa.com — Quality Control] | Botanical roots can carry heavy metals and mycotoxins, so contaminant testing is part of a complete certificate of analysis under 21 CFR Part 111. |
QC and testing considerations
- Every dietary ingredient must pass at least one validated identity test before use unless FDA has granted a petition exemption (21 CFR 111.75(a)(1)). Confirm your manufacturer runs identity testing on each incoming lot. [21 CFR 111.75(a)(1)]
- The Botanical Adulterants Prevention Program documents undeclared ashwagandha leaf and stem material substituted into root powders and extracts. Ask the supplier how root-only sourcing is verified and which withanolide marker is measured. [ABC-AHP-NCNPR BAPP — Ashwagandha Bulletin]
- Total withanolides and withanolide glycosides are different markers; confirm the CoA's marker matches your label basis rather than comparing figures across the two. [USP Ashwagandha Root Dry Extract monograph]
Further reading: How to read a certificate of analysis and third-party supplement testing.
Reference list
- USP Ashwagandha Root Dry Extract monograph (NLT 2.5% withanolides) Pharmacopeia
- 21 CFR Part 111 — Current Good Manufacturing Practice for dietary supplements (identity testing at 111.75) Regulatory
- KSM-66 (Ixoreal Biomed) — Quality Control page, owner site Owner technical
A reference list is not claim substantiation. Under the FTC's Health Products Compliance Guidance (December 2022), marketing claims about a finished product require competent and reliable scientific evidence, typically randomized, controlled human clinical testing. Responsibility for substantiating product claims rests with the brand.
Manufacturers with stated capability
No manufacturer has a listed capability for this ingredient yet. Listings are positive-only: an entry states a manufacturer can run the ingredient, never that one cannot.
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Further reading
The decision framework behind this reference: five checkable criteria for choosing between a branded ingredient and its generic form.
What this page does not tell you
- Whether the owner will license your specific product or accept a new account.
- Pricing, minimum order volumes, or contract terms.
- Anything about efficacy. This is an identity and sourcing reference.
Prefills the ingredient into the RFQ Spec Builder. You enter your own formula; the tool formats it into a spec sheet.
KSM-66 is a branded ingredient of Ixoreal Biomed. Inventory Ready is not affiliated with, licensed by, or endorsed by Ixoreal Biomed.
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