Berberine hydrochloride capsules

Berberine hydrochloride capsules

Berberine HCl, C20H18ClNO4 · vegan HPMC or declared gelatin capsule

Capsules built on berberine hydrochloride, CAS 633-65-8, NLT 97% by HPLC, isolated from Berberis aristata root and stem bark. Vegan HPMC shell as standard; gelatin origin declared where used.

Specifications

Active identityBerberine hydrochloride, C20H18ClNO4, MW 371.8, CAS 633-65-8. The berberine cation is C20H18NO4+, MW 336.4, CAS 2086-83-1, PubChem CID 2353.
Salt-to-base conversionThe chloride salt is 90.5% berberine cation by mass (336.4 / 371.85). Always state whether a label figure is berberine HCl or berberine base — the two are not interchangeable.
Assay and gradesBerberine HCl NLT 97.0% by HPLC on the dried basis as the standard article, with a 98.0% grade to order. Fill weight and capsule size fixed at order confirmation.
Botanical originBerberis aristata DC. — Indian barberry, tree turmeric, Daruharidra — root and stem bark from the Himalayas. Coptis chinensis and Phellodendron amurense are alternates.
Chemical class and appearanceQuaternary ammonium benzylisoquinoline (protoberberine) alkaloid. Bright yellow crystalline powder and a strong natural pigment; bitter taste.
Solubility and colour handlingSparingly soluble in cold water, more soluble hot; poorly soluble in most organic solvents. Colour bleed into clear shells is expected — specify opaque or coloured caps.
Capsule shell and originHPMC shell for a vegan article. Bovine gelatin quoted on request; porcine is not used unless requested in writing. Shell origin is stated on every batch record.
Fill and capsule specificationSize 0 and size 1 shells, fill 300–600 mg with MCC, silicon dioxide and vegetable magnesium stearate. Disintegration NMT 30 min at 37 °C; fill moisture NMT 6.0%.
Extraction and residual solventsIsolated with food-grade acidified water and ethanol, then recrystallised. No class 1 solvents; residues reported against ICH Q3C class 2 and class 3 limits per lot.
Contaminant limitsLead NMT 3.0 ppm, arsenic NMT 1.0 ppm, cadmium NMT 1.0 ppm, mercury NMT 0.1 ppm. Total plate count NMT 10,000 cfu/g; E. coli, Salmonella and S. aureus absent.
Allergen, origin and diet statusHPMC build is vegan, vegetarian and non-GMO, with no milk, egg, soy, fish, crustacean, gluten, sesame, peanut or nut input. A gelatin shell makes the article bovine, not vegan.
Regulatory and claim disciplineThovek makes no health claim for berberine. Botanical claims are unresolved in the EU register and national positions differ; confirm status for each destination market.
Shelf life and storage24 months from manufacture below 25 °C and 60% RH in the sealed original container. A yellow alkaloid — keep finished packs away from prolonged daylight.
HS code21069099 (India ITC-HS) for the encapsulated article. Bulk berberine HCl powder is 29397900 instead — see the classification note before consolidating a shipment.
Berberine hydrochloride is the salt form of berberine, a quaternary ammonium benzylisoquinoline (protoberberine) alkaloid. The salt is C20H18ClNO4, MW 371.8, CAS 633-65-8; the berberine cation itself is C20H18NO4+, MW 336.4, CAS 2086-83-1, PubChem CID 2353. That distinction is not academic — the chloride salt is only 90.5% berberine cation by mass, so a label that says "berberine 500 mg" and one that says "berberine HCl 500 mg" describe two different products. We state which basis a figure is on, on every certificate, and we will not issue a document that leaves it ambiguous. The feedstock is Berberis aristata DC. — Indian barberry, tree turmeric, Daruharidra — native to the Himalayas of India, Pakistan and Nepal and also found in the Nilgiris and Sri Lanka. Berberine sits in the root bark, rhizome and stem bark rather than the fruit, so root and stem bark are what enter the extraction line. Coptis chinensis and Phellodendron amurense are accepted alternate feedstocks where a customer's dossier already names them. The isolate is a bright yellow crystalline powder and a powerful natural pigment: it will tint clear capsule shells, stain tooling and equipment, and colour whatever it is blended into, which is a formulation fact worth designing around rather than discovering in production. Capsule shell choice is the origin decision that matters commercially. HPMC is the default and gives a vegan, vegetarian article free of milk, egg, soy, fish, crustacean, gluten, sesame, peanut and tree-nut input. Bovine gelatin is quoted on request and makes the finished capsule bovine, not vegan, with the consequences that follow for halal, kosher and vegan certification; porcine gelatin is not used unless a customer asks for it in writing. Shell origin is recorded on every batch document. Thovek makes no therapeutic or disease claim for berberine, describes it only on its chemistry and botanical origin, and notes that botanical health claims remain unresolved in the EU register while national positions on berberine in food supplements differ between markets — confirm the status in each destination before you commit to a launch.

Applications

Metabolic health capsule linesSingle-ingredient alkaloid capsulesPrivate-label botanical capsulesVegan HPMC capsule formatsPractitioner-channel supplementsContract encapsulation projectsBulk fill for tabletingSoftgel and sachet co-packing

Available grades

Berberine HCl NLT 97% by HPLC (standard) and NLT 98% to order; standard fills at 250 mg, 400 mg, 500 mg and 600 mg of berberine HCl, or set on a berberine-base basis to your specification; vegan HPMC shells in size 0 and size 1 as standard, bovine gelatin on request; standardised Berberis aristata root-bark extracts at 10%, 60% and 85% berberine for tableting; bulk berberine HCl powder supplied separately.

Packaging: Bulk capsules in 5 kg and 10 kg food-grade LDPE liners inside HDPE drums with desiccant. Retail-ready in 30, 60, 90 and 120-count HDPE bottles with induction seal, or Alu-Alu blisters in printed cartons. Opaque, light-protected packing as standard. Samples of 30 capsules against a signed sample request. Capsule shell origin is printed on every outer.

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