Ashwagandha & Shilajit Men's Blend Capsules

This is a finished dosage form, not a bulk powder, and the distinction governs everything from the specification to the tariff line. Each capsule carries a hydro-alcoholic root extract of Withania somnifera (L.) Dunal, family Solanaceae, together with purified shilajit — the herbo-mineral rock exudate traded as Asphaltum punjabianum and named Shilajatu in the Ayurvedic Pharmacopoeia of India. The ashwagandha fraction is standardised on total withanolides, the C28 steroidal lactone group that the USP monograph for Ashwagandha Root Dry Extract defines as the sum of withanolide aglycones calculated as withanolide A (CAS 32911-62-9) and withanolide glycosides calculated as withanoside IV, with a floor of NLT 2.5% on the dried basis; withaferin A (CAS 5119-48-2, C28H38O6, MW 470.6) is the marker that rises sharply when leaf material is present, which is why we use root only. The shilajit fraction is standardised on fulvic acid with humic acid as a secondary marker. The house reference build is a size 0 shell (nominal 0.67 mL) at a 500 mg fill, 300 mg of root extract at 5% total withanolides by HPLC with 200 mg of purified shilajit at not less than 50% fulvic acid, and the whole formula is rebuilt to a buyer's brief on strength, capsule size and count. Two analytical points decide whether a lot passes or fails at the buyer's goods-in bench. The first is where the assay is taken. Many suppliers quote the certificate of the input extract and let the buyer infer the content of the capsule; we release on the finished capsule, so the withanolide and fulvic acid figures on the certificate are per unit and sit alongside average fill weight and weight variation. The second is method. A gravimetric withanolide percentage and an HPLC withanolide percentage are different measurements on the same lot and gravimetry over-reads substantially, and fulvic acid behaves the same way across gravimetry, titrimetry and HPLC. Every certificate names the method and the reference standard, and we ask buyers to compare competing offers method for method rather than number for number. Heavy metals are the third control and shilajit is the reason: because it forms in mineral-bearing rock it can concentrate lead, arsenic, cadmium and mercury, so ICP-MS against the USP <2232> daily-exposure limits is a release parameter on every lot rather than a periodic check. We also screen each lot by LC-MS/MS for undeclared synthetic PDE-5 inhibitors — sildenafil, tadalafil and their analogues are the documented adulterants of products sold into this market segment, and a clean screen is a purity statement the buyer can put in front of a regulator. On origin and diet the shell is the variable that matters most, because the fill itself is uncomplicated. The ashwagandha fraction is plant-derived and the shilajit fraction is mineral-organic, so both are vegan and free of milk, egg, soy, fish, crustacean, mollusc, peanut, tree nut, sesame, mustard, celery, lupin and gluten-bearing cereals, and both are non-GMO. Formulators working nightshade-free lines should note that Withania somnifera is a Solanaceae botanical. With the standard hypromellose shell the finished capsule is vegan; with a gelatin shell it is vegetarian at best and carries bovine or porcine origin, which we declare on the specification rather than leaving to the order confirmation. Shells are supplied titanium dioxide free, E171 having lost its EU food-additive authorisation on 7 August 2022. Magnesium stearate, where used, is palm-derived rather than tallow-derived, and excipient-free fills are available. One further declaration is specific to this ingredient: classical shodhana of Shilajatu can be carried out in cow's milk, which would make the material a milk allergen, so our standard grade is purified in water only and any milk-processed grade is supplied only against a written order and declared as milk-containing. Thovek makes no therapeutic or disease claim for this product. Claim wording and its substantiation are the buyer's responsibility; health claims on botanicals remain unresolved and on hold in the EU under Regulation 1924/2006, and US structure-function claims require the statutory disclaimer and notification to FDA within thirty days of first marketing.