Ashwagandha root extract (high-withanolide)

Ashwagandha root extract (high-withanolide)

Withania somnifera (L.) Dunal · root only, withanolides NLT 5% HPLC

Root-only Withania somnifera extract, withanolides NLT 2.5% to USP or NLT 5% by HPLC, with the assay method stated in writing. No leaf material. Vegan, 25 kg drums.

Specifications

Botanical identityWithania somnifera (L.) Dunal (Solanaceae), dried mature root. Extract CAS 90147-43-6, EINECS 290-434-9. Known in Ayurveda as ashwagandha, Indian winter cherry.
Plant part control and originRoot only — no leaf, stem or berry. Cultivated Indian root from Neemuch/Mandsaur (MP) and Nagaur (Rajasthan); Nagauri ashwagandha holds a GI registration.
Assay / standardisationWithanolides NLT 2.5% by HPLC to the USP article, or NLT 5% by HPLC on the concentrated grade. Gravimetric grades quoted separately and labelled as gravimetric.
Assay basis — read carefullyGravimetric and HPLC results are not interchangeable: material assaying ~2.5% gravimetrically commonly reports 1-1.5% by HPLC. Fix the method before contracting.
USP reference valuesUSP Ashwagandha Root Dry Extract: NLT 2.5% withanolides, dried basis, as aglycones (as withanolide A) plus glycosides (as withanoside IV). Root powder: NLT 0.3%.
Key withanolidesWithanolide A (CAS 32911-62-9) and withaferin A (CAS 5119-48-2), both C28H38O6, MW 470.6; withanosides IV and V. Withaferin A reported and capped on request.
Extraction and solventPurely aqueous extraction available for alcohol-free specifications; hydroalcoholic grades also supplied. USP permits water, alcohol, methanol or mixtures.
Drug-to-extract ratio and carrierNative DER stated on every specification. Carrier-free where the assay allows; otherwise the carrier (maltodextrin or organic rice flour) is named and quantified.
Appearance and particle sizeOff-white to light brown fine powder, characteristic odour, bitter taste. NLT 95% through 80 mesh (BSS). Water-dispersible and granular grades on request.
Water, ash and residual solventsLoss on drying NMT 5.0%; total ash NMT 8.0%; acid-insoluble ash NMT 2.0%; residual ethanol within ICH Q3C; no class 1 or chlorinated solvents used.
Heavy metals and microbiologyICP-MS: lead NMT 3.0, arsenic NMT 2.0, cadmium NMT 1.0, mercury NMT 0.1 ppm. TPC NMT 10,000 cfu/g; yeast and mould NMT 500 cfu/g; E. coli and Salmonella absent.
Allergen and dietary statusVegan, plant-derived; not bovine, porcine or marine. Free of milk, egg, soy, fish, crustacean, nut, sesame and gluten. Solanaceae — NOT a nightshade-free ingredient.
Market access noteDenmark prohibits ashwagandha in food supplements and other EU states have restricted or are reviewing it. Confirm destination-market status before ordering.
Shelf life, storage24 months sealed below 25 °C, protected from light and moisture.
HS code13021919
This is a root-only extract of Withania somnifera (L.) Dunal (Solanaceae), the Ayurvedic drug ashwagandha; extract CAS 90147-43-6, EINECS 290-434-9. Thovek supplies it from cultivated Indian root, principally from the Neemuch, Mandsaur and Manasa belt of western Madhya Pradesh and from Nagaur in Rajasthan, whose Nagauri ashwagandha holds a Geographical Indication registration and is the trade's preferred long, thick root. No leaf, stem or berry enters the charge. That restriction is not cosmetic: leaf material carries a markedly different withanolide profile, is richer in withaferin A, and a leaf-containing article sold against a root specification is a documented labelling problem in this ingredient. Root-only identity is confirmed on every lot by HPLC and HPTLC fingerprint rather than by assay alone. The assay is where ashwagandha contracts most often go wrong, so it is worth being blunt. "Withanolides" can be measured gravimetrically or by HPLC, and the two numbers are not interchangeable — material that assays around 2.5% gravimetrically commonly reports only 1-1.5% by HPLC, and because the method is rarely printed on a label two suppliers quoting "2.5% withanolides" can be offering materially different goods at materially different prices. Thovek names the method on the specification and on every certificate of analysis and will run the assay on whichever basis the buyer's own release specification uses. The pharmacopoeial anchor is USP Ashwagandha Root Dry Extract, which requires not less than 2.5% withanolides on the dried basis, calculated as the sum of withanolide aglycones (as withanolide A) plus withanolide glycosides (as withanoside IV), and permits water, alcohol, methanol or mixtures as extraction solvents; the companion USP Ashwagandha Root Powder monograph sets 0.3% on the same footing. Withanolide A and withaferin A share the formula C28H38O6, MW 470.6, with CAS 32911-62-9 and 5119-48-2 respectively. Withaferin A is reported per lot and can be capped to a buyer limit — a request that has become common as formulators tighten their own safety files. Buyers should also plan around market access before they order. Denmark prohibits ashwagandha in food supplements, and several other EU member states have restricted or are reviewing it, so destination-market status must be confirmed rather than assumed; the ingredient remains freely used in the United States, India and much of Asia. On the technical side, a purely aqueous extraction is available where an alcohol-free declaration is required, alongside conventional hydroalcoholic grades, and the native drug-to-extract ratio is stated on every specification with any carrier named and quantified rather than hidden inside the assay. The material is plant-derived and vegan, with no bovine, porcine, marine, dairy, egg, fish, crustacean, nut, sesame or gluten input; note only that Withania is a Solanaceae member, so this is not a nightshade-free ingredient. Every lot ships with a full certificate of analysis: HPLC assay and identity, loss on drying, ash, heavy metals by ICP-MS, residual solvents against ICH Q3C, pesticide screening and microbiology.

Applications

Adaptogen capsule formulationsSports nutrition premixesAyurvedic proprietary formulationsProtein and recovery blendsFunctional beverage premixesGummy and chewable formatsTablet and capsule blendsNutricosmetic formulations

Available grades

Root-only withanolides NLT 2.5% by HPLC (USP-conforming) and NLT 5% by HPLC; gravimetric grades at 1.5%, 2.5%, 5% and 10% quoted and labelled separately as gravimetric; purely aqueous alcohol-free grade; hydroalcoholic grade; 10:1 native-DER root extract; water-dispersible and cold-water-soluble formats; organic-certified root extract; plain milled ashwagandha root powder. Options: kosher, halal, non-GMO, vegan and nightshade-declared statements, banned-substance programme documentation for sports brands, buyer-set withaferin A caps, and tightened heavy-metal and pesticide limits.

Packaging: 25 kg net in fibre or food-grade HDPE drums with double food-grade LDPE liners; 1 kg, 5 kg and 10 kg aluminium-foil laminate pouches for pilot and R&D lots. Nitrogen flush and desiccant on request; opaque packaging as standard. Palletised and shrink-wrapped for FCL or LCL. Free 100 g samples and 1 kg trial quantities.

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