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.
| Identity | Ox 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 article | Total 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 profile | Mainly conjugated: taurocholic, glycocholic, taurodeoxycholic, glycodeoxycholic, tauro- and glycochenodeoxycholic; free cholic, deoxycholic and chenodeoxycholic minor. |
| Reference constituent | Cholic 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 odour | Yellowish-green to amber-brown powder or soft solid; characteristic animal odour; strongly bitter taste. Hygroscopic — protect from moisture. |
| Solubility and pH | Soluble 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 drying | NMT 6.0%. Sulphated ash and residual solvent (ethanol) to specification; ethanol residues controlled to ICH Q3C Class 3 limits. |
| Species and origin | Bovine 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 status | India 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 status | Contains 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 certification | Bovine — 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 microbiology | Heavy 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 presentation | 125 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 life | 36 months from manufacture in unopened original packing, stored below 25 °C in a dry place away from light. |
| HS code | 21069099 as a finished capsule supplement |
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.
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