Berberine HCl

Berberine HCl

Berberine hydrochloride · C20H18ClNO4

Isolated berberine hydrochloride, assay NLT 97% by HPLC, CAS 633-65-8. Plant-extracted or synthetic origin declared, with impurity documentation. Vegan, non-GMO, bulk from India.

Specifications

Chemical identityBerberine hydrochloride, also called berberine chloride. A quaternary protoberberine isoquinoline alkaloid salt; a discrete chemical, not a plant extract.
CAS numbers633-65-8 anhydrous chloride salt; 5956-60-5 dihydrate, the usual commercial form; 2086-83-1 berberine cation/free base. The supplied form is named on the CoA.
Molecular formula and weightC20H18ClNO4, also written C20H17NO4.HCl. MW 371.81 anhydrous; approx. 407.8 as the dihydrate.
AssayNLT 97.0% by HPLC on the dried or anhydrous basis, UV detection near 345 nm; 98% grade available. Identity by IR and HPLC retention against a reference standard.
AppearanceBright yellow crystalline powder, practically odourless, intensely bitter. A strong natural yellow colourant that stains equipment and textiles.
Melting pointReported 204-206 degrees C with decomposition.
SolubilitySlightly soluble in cold water and more soluble in hot water; sparingly soluble in ethanol; practically insoluble in chloroform and ether. Hygroscopic.
Loss on drying8.0-12.0% for the dihydrate grade; NMT 3.0% for anhydrous material. Always reconcile the assay basis against LOD before calculating a formula overage.
Origin route (declared)Plant-extracted from Berberis aristata, Coptis chinensis or Phellodendron species, or chemically synthesised. Route is stated per lot and never left implicit.
Impurity note by routeSynthetic routes using veratraldehyde with secondary amines, nitrite and strong acid carry nitrosamine risk; aqueous/alcoholic plant extraction does not create those conditions.
Origin verificationStable isotope ratio analysis (SIRA) can discriminate plant-derived from synthetic berberine and is available as an add-on test where a natural-origin label claim is made.
Heavy metals and microbiologyPb NMT 3 ppm, As NMT 1 ppm, Cd NMT 1 ppm, Hg NMT 0.1 ppm. TPC NMT 1,000 cfu/g; yeast and mould NMT 100 cfu/g; E. coli, Salmonella and S. aureus absent.
Particle sizeNLT 95% through 80 mesh as standard. Micronised and granulated grades available for direct compression and capsule filling.
Allergen, diet and origin statusVegan and vegetarian. No milk, egg, soy, fish, crustacean, gluten, peanut or tree-nut inputs; no animal, bovine, porcine or marine material. Non-GMO. Halal and Kosher on request.
Regulatory note for buyersEFSA draft opinion endorsed Jan 2026 set no safe berberine intake level (consultation 2 Mar-4 May 2026); ANSES opined in 2019; Belgium caps 10 mg/day. Verify destination rules.
Shelf life36 months from manufacture in unopened original packing, cool and dry, protected from light and moisture.
HS code2939 79 90
Berberine hydrochloride is the isolated hydrochloride salt of berberine, a quaternary protoberberine isoquinoline alkaloid. It is a discrete chemical, not a botanical extract, and Thovek treats it as such throughout: a bright yellow crystalline powder assayed at not less than 97.0 percent by HPLC with UV detection near 345 nm, supported by identity by IR and by comparison with a characterised reference standard. CAS numbering needs care on paperwork because three numbers are in circulation for closely related forms — 633-65-8 for the anhydrous chloride salt, 5956-60-5 for the dihydrate that most commercial material actually is, and 2086-83-1 for the berberine cation or free base. The molecular formula is C20H18ClNO4, also written C20H17NO4.HCl, with a molecular weight of 371.81 for the anhydrous salt and roughly 407.8 for the dihydrate. Because the two differ by about nine percent in mass, assay basis and loss on drying must be read together or a buyer will over- or under-dose a formula by that margin. Origin is the commercial fault line in this ingredient and we state it explicitly on every certificate. Berberine HCl reaches the market by two entirely different routes: extraction and purification from berberine-bearing plants such as Berberis aristata, Coptis chinensis and Phellodendron species, or multi-step chemical synthesis typically starting from veratraldehyde. Synthesis is cheaper and higher-yielding, which is why the surge in berberine demand has drawn a great deal of synthetic material into supplement supply chains, sometimes without disclosure. The published concern with the synthetic route is the potential for nitrosamine formation, since it combines secondary amines, nitrite sources and strong acid conditions, whereas aqueous and alcoholic plant extraction does not create those conditions. Stable isotope ratio analysis has been shown to discriminate naturally sourced from synthetic berberine, and buyers who label a product as plant-derived should be prepared to substantiate it. Thovek will supply either route on request, but never conflates them, and provides route-appropriate impurity and residual-solvent data with each lot. The salt is vegan and vegetarian with no animal, dairy, egg, soy, fish, crustacean, gluten or nut inputs, is non-GMO, and is an intense natural yellow colourant that will stain equipment and adjacent product if dust is not controlled. It is slightly soluble in cold water and more soluble in hot water, sparingly soluble in ethanol, and hygroscopic, so drums should be resealed promptly. Buyers selling into Europe should diligence the position themselves before committing: EFSA's NDA Panel endorsed a draft opinion in January 2026 concluding that no safe intake level could be established for berberine-containing plant preparations, with public consultation running 2 March to 4 May 2026, France's ANSES published an opinion in 2019, and Belgium applies a 10 mg per day berberine limit in food supplements. Thovek supplies composition and analytical data only and makes no health or therapeutic claim of any kind.

Applications

metabolic supplement formulationscapsule and tablet fillscombination softgel productssports nutrition stacksveterinary nutraceutical premixesnatural yellow colourantanalytical reference materialcosmetic and topical actives

Available grades

Assay 97% and 98% by HPLC; dihydrate (the usual commercial form) or dried anhydrous basis; plant-extracted grade from Berberis aristata, Coptis chinensis or Phellodendron, and synthetic grade, each with route-appropriate impurity and residual-solvent data; standard 80 mesh, micronised and granulated direct-compression grades; SIRA natural-origin verification available as an add-on.

Packaging: 25 kg net in a food-grade double LDPE liner inside a fibre or HDPE drum; 5 kg and 1 kg aluminium foil laminate pouches for pilot batches. The salt is hygroscopic and light-sensitive, so reseal the inner liner immediately after sampling and store cool, dry and dark. Dedicated scoops and liners are advised because the powder stains heavily.

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