Ox bile extract

Ox bile extract

Bovine bile extract · total bile acids NLT 45%

Dried bovine bile extract, CAS 8008-63-7, standardised to total bile acids NLT 45%. Conjugated cholic and deoxycholic acids. Bovine origin — not vegan or vegetarian. Bulk powder and finished capsules.

Specifications

IdentityOx bile extract (purified oxgall, sodium choleate), CAS 8008-63-7. Affirmed GRAS as a food surfactant at 21 CFR 184.1560. Not a single chemical — a natural bile acid mixture.
Assay — standard articleTotal bile acids NLT 45% by enzymatic (3-alpha-hydroxysteroid dehydrogenase) assay. NLT 60% grade available; separate 42–45% cholic acid grade to order.
Bile acid profileMainly conjugated: taurocholic, glycocholic, taurodeoxycholic, glycodeoxycholic, tauro- and glycochenodeoxycholic; free cholic, deoxycholic and chenodeoxycholic minor.
Reference constituentCholic acid, C24H40O5, MW 408.6, CAS 81-25-4, PubChem CID 221493 — the principal free bile acid used as the HPLC reference standard on the COA.
Appearance and odourYellowish-green to amber-brown powder or soft solid; characteristic animal odour; strongly bitter taste. Hygroscopic — protect from moisture.
Solubility and pHSoluble in water and in ethanol, forming a clear to slightly opalescent solution; surface-active above the critical micelle concentration. pH of a 2% aqueous solution 7.0–8.5.
Loss on dryingNMT 6.0%. Sulphated ash and residual solvent (ethanol) to specification; ethanol residues controlled to ICH Q3C Class 3 limits.
Species and originBovine bile from healthy animals at government-registered abattoirs. Species (Bos taurus/indicus or Bubalus bubalis), abattoir and country of collection declared on every COA.
TSE/BSE statusIndia holds WOAH negligible BSE risk status. Every lot ships with a TSE/BSE statement; no ruminant CNS, spinal or specified risk material enters the process.
Allergen statusContains no milk, egg, soy, wheat/gluten, fish, crustacean, peanut or tree nut. Bile is not a dairy product. Declare as animal-derived, not as an allergen.
Diet and certificationBovine — NOT vegan and NOT vegetarian. Halal and kosher only where the slaughter itself is certified; certificates supplied on request against a nominated abattoir.
Purity and microbiologyHeavy metals: Pb NMT 1.0, As NMT 1.0, Cd NMT 0.5, Hg NMT 0.1 ppm. TPC NMT 10,000 cfu/g; yeast and mould NMT 500 cfu/g; E. coli and Salmonella absent.
Capsule presentation125 mg, 250 mg and 500 mg fills in size 1 and size 0 shells; HPMC or bovine gelatin; immediate, delayed-release or enteric. Bulk-pack or blistered to brand artwork.
Shelf life36 months from manufacture in unopened original packing, stored below 25 °C in a dry place away from light.
HS code21069099 as a finished capsule supplement
Ox bile extract is the concentrated, dried extract of bovine bile — in the words of the US food regulation that affirms it (21 CFR 184.1560), a yellowish green soft solid obtained by evaporating the alcohol extract of concentrated bile, CAS 8008-63-7, also traded as purified oxgall or sodium choleate. It is not a single molecule but a natural mixture, and most of it is conjugated: taurocholic and glycocholic acids lead, with taurodeoxycholic, glycodeoxycholic, taurochenodeoxycholic and glycochenodeoxycholic acids present, plus smaller amounts of the free acids cholic (C24H40O5, MW 408.6, CAS 81-25-4), deoxycholic and chenodeoxycholic. Chemically these are amphipathic steroid surfactants: above their critical micelle concentration they build mixed micelles with phospholipid and disperse fat into a finely divided form. That surface-active behaviour is the established food-technology function of the material, and it is exactly why 21 CFR lists ox bile extract as a GRAS surfactant. Species and origin are the two things a buyer must pin down before ox bile ships out of India, and most enquiries get this wrong. Cattle slaughter is prohibited or tightly restricted across most Indian states and the export of cow and calf beef is banned outright, so the bovine by-product stream actually available in India is overwhelmingly water buffalo (Bubalus bubalis, carabeef). Material offered as “ox bile” from an Indian plant is therefore commonly buffalo bile unless the paperwork says otherwise. Thovek names the species of origin, the approved abattoir and the country of collection on every certificate of analysis, and will source genuine Bos taurus material under certificate where a customer’s label, market or pharmacopoeial reference requires it. India holds WOAH negligible BSE risk status and each lot ships with a TSE/BSE statement. On allergens and diet: the material is of bovine origin, so it is neither vegan nor vegetarian, and it is halal or kosher only where the slaughter itself is certified. Bile is not a milk product and the extract carries no dairy allergen; it is also free from gluten, soy, egg, fish, crustacean and tree nut. Thovek supplies ox bile extract both as bulk powder for encapsulation and as a finished capsule under contract. Standard bulk grades are total bile acids NLT 45% and NLT 60%, with a 42–45% cholic acid grade for buyers who specify on cholic acid, and a bacteriological oxgall grade used in microbiological media and in bile-tolerance screening of probiotic strains. The powder is hygroscopic and strongly bitter, so it is normally encapsulated rather than tabletted or chewed: typical fills are 125 mg, 250 mg and 500 mg in size 1 and size 0 shells. The shell can be HPMC where a brand wants a plant-derived capsule even though the fill itself is animal-derived, or bovine gelatin; delayed-release and enteric shells are available. Co-blends with pancreatin, fungal lipase, betaine hydrochloride or a multi-enzyme complex are made to the customer’s own formula and unit dose.

Applications

Digestive enzyme capsule blendsBile acid supplement capsulesLipase and bile combinationsBetaine hydrochloride digestive stacksBacteriological oxgall mediaProbiotic bile-tolerance screeningVeterinary digestive premixesSoftgel and tablet fillsPrivate-label contract capsules

Available grades

Total bile acids NLT 45% (standard) and NLT 60%; cholic acid 42–45% grade; bacteriological oxgall for microbiological media and bile-tolerance screening; granulated free-flowing powder for high-speed encapsulation; finished capsules at 125 mg, 250 mg and 500 mg fill in HPMC or bovine gelatin shells, immediate, delayed-release or enteric; buffalo or Bos taurus origin declared per lot.

Packaging: Bulk powder in 1 kg and 5 kg aluminium-foil laminate bags heat-sealed inside HDPE drums, and 25 kg fibre drums with a double food-grade LDPE liner; packed with desiccant sachets because the extract is hygroscopic. Finished capsules bulk-packed in HDPE jars of 500 or 1,000 with a double LDPE liner, or blistered and cartoned to the brand’s artwork. Samples at 100 g and 500 g, or 100 capsules, against a signed sample request.

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