Nattokinase Capsules

Nattokinase Capsules

Bacillus subtilis var. natto fermentation enzyme (EC 3.4.21.62) · potency declared in FU

Hard capsules filled with nattokinase, the subtilisin-family serine protease from Bacillus subtilis var. natto, potency declared in fibrinolytic units. Vegan HPMC or gelatin shells, private label.

Specifications

Enzyme identityNattokinase, a subtilisin-family serine protease; EC 3.4.21.62; MEROPS S08.044, also named subtilisin NAT (synonyms subtilisin QK, subtilisin QK02)
Source organismBacillus subtilis var. natto grown on cooked whole soybean; the secreted enzyme is recovered from the ferment and dried onto a food-grade carrier
Protein dataMature chain of 275 amino acid residues (residues 107-381 of the precursor); theoretical mass 27,726.74 Da
Potency basisDeclared in fibrinolytic units (FU): one FU is the amount of enzyme that releases 1 µg of tyrosine per minute under the fibrin assay conditions
Fill calculationFill follows the concentrate potency - a 20,000 FU/g concentrate gives 2,000 FU in a 100 mg fill; label FU and stability overage fixed by the approved formula
Vitamin K2 (MK-7)Natto assays at 1,034 µg vitamin K2 per 100 g, about 90% of it MK-7; K2-reduced grades available and the per-lot MK-7 result is reported either way
Capsule shellVegetarian HPMC for vegan builds, or bovine gelatin; size 0 or 1 typical; halal and kosher shells on request; band sealing available as a moisture barrier
Allergen statusFermented on soybean - declare soy under EU Reg. 1169/2011 Annex II and US FALCPA. No milk, egg, fish, crustacean, peanut, tree nut or gluten input
Origin / diet statusMicrobial fermentation of a plant substrate - no bovine, porcine or marine material; vegan and vegetarian when supplied in HPMC shells; non-GMO declaration available
Appearance of fillFree-flowing powder, off-white to light tan depending on the carrier and the concentrate lot; capsule colour, print and deboss to buyer artwork
Purity and microbiologyTested to food-grade enzyme preparation limits: heavy metals, Salmonella, E. coli, coliforms, total plate count, yeast and mould; antimicrobial activity absent
StorageStore below 25 °C at relative humidity not above 60%, away from light and moisture; activity is heat- and humidity-sensitive, so alu-alu is the preferred blister
Shelf life24 months from manufacture in the unopened original pack; activity retest and formula-specific stability data supplied on request
HS code21069099 as finished capsules; bulk nattokinase enzyme concentrate classifies to 35079099
Nattokinase is the fibrinolytic serine protease that Bacillus subtilis var. natto secretes while fermenting cooked whole soybeans into natto. It is classified EC 3.4.21.62 and catalogued in MEROPS as subtilisin NAT (S08.044), placing it squarely in the subtilisin family; the mature chain runs to 275 amino acid residues with a theoretical mass of 27,726.74 Da. Thovek supplies it as a finished two-piece hard capsule, filled with a dried fermentation concentrate to the activity the buyer specifies, with bulk concentrate available separately for buyers who blend in-house. Activity, not weight, is what the trade buys. Potency is declared in fibrinolytic units, where one FU is the quantity of enzyme that releases 1 µg of tyrosine per minute under the fibrin assay conditions, so the capsule fill follows arithmetically from the concentrate: a 20,000 FU/g concentrate delivers 2,000 FU in a 100 mg fill, and the label figure carries a stability overage set from the formula. The second number to fix at enquiry is vitamin K2. Natto is the richest known food source of long-chain menaquinone — reported at 1,034 µg of vitamin K2 per 100 g, roughly 90% of it MK-7 — so the K2 carried along by a natto-derived concentrate is a formulation and labelling variable the buyer has to control. K2-reduced grades are available and the per-lot MK-7 result is reported either way. Origin and allergen status are simple but must be stated in writing. The ferment runs on soybean, so the material is declared as containing soy under EU Regulation (EU) 1169/2011 Annex II and US FALCPA unless the buyer holds validated soy-protein-free data on the specific lot. There is no milk, egg, fish, crustacean, peanut, tree nut or gluten input and no animal-derived material in the enzyme itself, so a vegetarian HPMC shell gives a fully vegan capsule; bovine gelatin shells are supplied where a buyer's range calls for them. Capsules are made in an FSSAI-licensed GMP facility and shipped with a batch certificate of analysis covering FU activity, MK-7 content, heavy metals and microbiology, alongside allergen, non-GMO, halal and kosher statements as required.

Applications

Private-label capsule brandsContract manufacturing programmesVegan supplement rangesHealthy-ageing product linesMulti-enzyme blend componentPharmacy own-label linesE-commerce subscription SKUsExport distributor supply

Available grades

Health-supplement grade fermentation enzyme concentrate; FSSAI-licensed GMP manufacture with HACCP and ISO 22000; vegetarian HPMC (vegan) or bovine gelatin shells; halal, kosher, non-GMO and gluten-free declarations; vitamin K2-reduced grade on request

Packaging: Alu-alu or PVDC blisters of 10, 15 or 30 capsules in printed mono-cartons with leaflet, or 30/60/90/120-count HDPE bottles with induction seal, silica-gel desiccant and optional child-resistant cap; alu-alu is preferred over PVC-based films for an enzyme fill. Unpacked bulk capsules ship in double food-grade LDPE liners inside 20-25 kg fibre drums, and bulk nattokinase concentrate powder in the same liner-and-drum format. Cartons and bottles are shrink-wrapped into 5-ply export corrugated shippers, strapped and palletised on ISPM-15 heat-treated pallets, batch-coded at every level.

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