KSM-66
ashwagandha root extract (Withania somnifera)
AshwagandhaLast reviewed: 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.[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 (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.
Run this ingredient? Request inclusion.
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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