Alpha-Galactosidase Tablets

Alpha-Galactosidase Tablets

Aspergillus niger alpha-galactosidase (EC 3.2.1.22, CAS 9025-35-8) · potency declared in GalU

Compressed tablets of Aspergillus niger alpha-galactosidase, the enzyme that opens raffinose-family oligosaccharides in pulses and brassicas. GalU-declared potency, vegan, private label.

Specifications

Enzyme identityAlpha-galactosidase (alpha-D-galactoside galactohydrolase), EC 3.2.1.22, CAS 9025-35-8
Source organismAspergillus niger, food-grade submerged or solid-state fermentation; A. niger fermentation carries US FDA GRAS status under the Federal Food, Drug, and Cosmetic Act
Catalytic actionHydrolyses terminal, non-reducing alpha-D-galactose residues in alpha-D-galactosides, including galacto-oligosaccharides, galactomannans and galactolipids
Target substratesRaffinose-family oligosaccharides of pulses, soy and brassicas - raffinose (C18H32O16, CAS 512-69-6), stachyose, verbascose; also melibiose to galactose plus glucose
Why it is suppliedHuman digestion has no alpha-galactosidase, so RFOs reach the colon intact and are fermented there by gut bacteria that do carry it, yielding short-chain fatty acids and gas
pH and temperatureAcid-active fungal enzyme; a purified A. niger alpha-galactosidase was characterised at pH 3.5 and 60 °C optimum, with the exact optimum strain- and preparation-dependent
Potency basisDeclared in GalU (galactosidase units); the assay method and unit definition are written into the specification agreed with the buyer, as definitions differ between houses
Dosage formCompressed tablet - uncoated, HPMC film-coated, chewable or orally disintegrating; shape, deboss and coating colour to buyer brief
Tablet weightTypically 250-800 mg, set by the enzyme load, the carrier system and the disintegration profile required
ExcipientsMicrocrystalline cellulose, mannitol, croscarmellose sodium, colloidal silica and magnesium stearate or vegetable-source alternatives; excipient set to buyer preference
Allergen statusNo milk, egg, fish, crustacean, soy, peanut, tree nut or gluten input; fungal fermentation origin (A. niger) declared on the label and specification
Origin / diet statusVegan and vegetarian - no bovine, porcine or marine material at any stage; halal and kosher certification available; non-GMO declaration on request
Purity and microbiologyLead and heavy metals, Salmonella, E. coli, coliforms, total plate count, yeast and mould, mycotoxin screen appropriate to a fungal enzyme; antimicrobial activity absent
Storage and shelf lifeBelow 25 °C at RH not above 60%; 24 months from manufacture in the unopened alu-alu blister or desiccated HDPE bottle, supported by stability data
HS code21069099 as finished tablets; bulk alpha-galactosidase enzyme preparation classifies to 35079099
Alpha-galactosidase (EC 3.2.1.22, CAS 9025-35-8) is the glycoside hydrolase that clips terminal, non-reducing alpha-D-galactose residues off alpha-D-galactosides - galacto-oligosaccharides, galactomannans and galactolipids - and splits melibiose into galactose and glucose. Human digestion carries no enzyme that does this. The raffinose-family oligosaccharides in pulses, soy and brassicas (raffinose, C18H32O16, CAS 512-69-6; the tetrasaccharide stachyose; the pentasaccharide verbascose) therefore reach the colon intact, where gut bacteria that do carry alpha-galactosidase ferment them to short-chain fatty acids and gas. Supplying the enzyme alongside the meal is a food-technology answer to a substrate the small intestine cannot open. The commercial enzyme is a fermentation product of Aspergillus niger - the same workhorse the industry runs for glucoamylase, pectinases, fructosyltransferase and citric acid, and whose fermentation carries US FDA GRAS status. It is an acid-active enzyme, which suits the point in digestion at which it has to work: a purified A. niger alpha-galactosidase has been characterised with maximum activity at pH 3.5 and 60 degrees C, though the exact optimum is strain- and preparation-dependent. Thovek presents it as a compressed tablet - uncoated, HPMC film-coated, chewable or orally disintegrating - with strength declared in GalU and the assay method written into the agreed specification, because GalU definitions differ between houses and a unit figure without its method is not a specification. Because the active is fungal rather than animal- or plant-protein derived, the allergen picture is clean: no milk, egg, fish, crustacean, soy, peanut, tree nut or gluten input, and the material is vegan and vegetarian with halal and kosher certification available. The Aspergillus niger origin is stated on the label and in the specification, since some buyers screen for fungal-derived actives regardless of allergen status. Tablets are produced in an FSSAI-licensed GMP facility and shipped with a batch certificate of analysis covering GalU activity, disintegration, weight variation, hardness and friability, heavy metals, a mycotoxin screen appropriate to a fungal enzyme, and microbiology, together with allergen, vegan, non-GMO, halal and kosher statements and full export paperwork.

Applications

Private-label enzyme tabletsContract tablet manufacturingVegan supplement rangesPlant-protein diet formulasMulti-enzyme blend componentPharmacy own-label linesE-commerce supplement brandsTravel and trial packs

Available grades

Food and health-supplement grade Aspergillus niger enzyme preparation tested on FCC-style enzyme criteria; FSSAI-licensed GMP manufacture with HACCP and ISO 22000; vegan, vegetarian, halal, kosher, non-GMO and gluten-free declarations available

Packaging: Alu-alu, PVDC or alu-PVC blisters of 10, 15 or 30 tablets in printed mono-cartons with leaflet, or 30/60/90/120-count HDPE bottles with induction seal and silica-gel desiccant; alu-alu is recommended for an enzyme tablet because the barrier controls the moisture that costs activity. Unpacked bulk tablets ship in double food-grade LDPE liners inside 20-25 kg fibre drums, as does bulk enzyme powder. Cartons and bottles are shrink-wrapped into 5-ply export corrugated shippers with partitions, strapped and palletised on ISPM-15 heat-treated pallets, batch-coded at carton, bottle and shipper level.

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