Milk Thistle Extract (Silymarin 80%)

Milk Thistle Extract (Silymarin 80%)

Silybum marianum fruit · silymarin 80% expressed as silibinin (C25H22O10)

De-fatted Silybum marianum fruit extract standardised to 80% silymarin by UV, expressed as silibinin. HPLC-assayed Ph. Eur. and USP grades also offered. Vegan, non-GMO, allergen-free.

Specifications

Botanical identitySilybum marianum (L.) Gaertn., family Asteraceae — ripe fruits (achenes), commonly traded as seed. De-hulled and de-fatted before extraction
Marker identitySilymarin flavonolignan complex, CAS 65666-07-1, expressed as silibinin (silybin), C25H22O10, MW 482.4, PubChem CID 31553
StandardisationSilymarin NLT 80.0% expressed as silibinin, by UV spectrophotometry. Method stated on every CoA; a UV result is not interchangeable with an HPLC result
Pharmacopoeial gradesPh. Eur. 2071 refined and standardised dry extract: nominal silymarin 30–65% m/m as silibinin, HPLC. USP: NLT 90.0%–NMT 110.0% of label, as silybin, dried basis
Flavonolignan profile (USP)Within silymarin: silydianin + silychristin 20.0–45.0%; silybin A + silybin B 40.0–65.0%; isosilybin A + isosilybin B 10.0–20.0%. Full profile on request
AppearanceLight yellow to yellow-brown fine free-flowing powder, characteristic odour and slightly bitter taste; passes 80 mesh unless another cut is specified
SolubilityPoorly soluble in water; soluble in ethanol, methanol and acetone. Phospholipid-complexed and water-dispersible grades offered as separate articles
Extraction solventsFood-grade ethanol, methanol, acetone or ethyl acetate after hexane de-fatting; residual solvents controlled to ICH Q3C Class 2 and Class 3 limits
Allergen statusFree of milk, egg, soy, fish, crustacean, mollusc, peanut, tree nut, sesame, mustard, celery, lupin and gluten. Name notwithstanding, contains no dairy
Origin and dietFruit/seed-derived. Vegan and vegetarian; not bovine, porcine, marine or dairy-derived. Non-GMO. Halal and kosher certification available
Purity limitsLoss on drying NMT 5.0%; sulphated ash NMT 5.0%; lead NMT 3 ppm, arsenic NMT 2 ppm, cadmium NMT 1 ppm, mercury NMT 0.1 ppm; pesticides to EU MRLs
MycotoxinsAflatoxin B1 NMT 2 µg/kg and total aflatoxins B1+B2+G1+G2 NMT 4 µg/kg; ochratoxin A NMT 10 µg/kg. Tested per lot on an oilseed-derived raw material
MicrobiologyTotal plate count NMT 10,000 cfu/g; yeast and mould NMT 100 cfu/g; E. coli, Salmonella and S. aureus absent in 10 g / 25 g as applicable
Shelf life and storage24 months from manufacture in sealed original packaging below 25 °C, protected from light, air and moisture. Hygroscopic; reseal opened liners promptly
HS code1302.19 (13021919)
Milk Thistle Extract, Silymarin 80%, is made from the ripe fruits (achenes, traded as seed) of Silybum marianum (L.) Gaertn., family Asteraceae. The fruits are de-hulled and de-fatted, then extracted with food-grade ethanol, methanol, acetone or ethyl acetate and concentrated to a light yellow to yellow-brown free-flowing powder. Silymarin is not one molecule but a flavonolignan complex, CAS 65666-07-1, expressed against silibinin, C25H22O10, MW 482.4, PubChem CID 31553. The complex contains silybin A and silybin B (together silibinin), isosilybin A and isosilybin B, silychristin and silydianin, together with the flavonoid precursor taxifolin. The 80% figure needs reading carefully, and Thovek states the method on every certificate. An 80% silymarin claim is a spectrophotometric (UV) result, and a UV method reads total absorbing flavonoid material without separating the individual flavonolignans. The pharmacopoeial methods are chromatographic and give a materially lower number on the same lot: Ph. Eur. monograph 2071, milk thistle dry extract refined and standardised, sets a nominal silymarin content of 30 to 65 per cent m/m expressed as silibinin, and USP Powdered Milk Thistle Extract requires NLT 90.0% and NMT 110.0% of the labelled silymarin calculated as silybin on the dried basis. A UV 80% and an HPLC 30–65% are not competing claims about the same measurement, and quoting one against the other is the most common source of dispute on this ingredient. Thovek supplies both a UV-80% commodity grade and HPLC-assayed Ph. Eur. and USP grades, priced and documented separately. USP also fixes the internal proportions of the complex, which is what distinguishes a genuine milk thistle extract from a topped-up one: within silymarin, silydianin plus silychristin must be 20.0–45.0%, silybin A plus silybin B 40.0–65.0%, and isosilybin A plus isosilybin B 10.0–20.0%. Thovek reports the full flavonolignan profile by HPLC on request so buyers can audit that ratio. The powder is poorly soluble in water and soluble in ethanol and acetone, so a phospholipid-complexed grade is offered separately for buyers who need dispersibility. Material is fruit-derived, vegan and vegetarian, non-GMO, and free of milk, egg, soy, fish, crustacean, mollusc, peanut, tree nut, sesame, mustard, celery, lupin and gluten. Milk thistle carries the word milk only as a common name for the white leaf veining; it contains no dairy and no milk protein, and a dairy-free declaration is issued as standard because that name causes recurring confusion on finished-product labels.

Applications

Herbal supplement capsulesTablet and caplet formulationsSoftgel oil suspensionsSingle-herb standardised productsMulti-botanical herbal blendsPhospholipid complex manufactureVeterinary nutraceutical premixesFunctional beverage sachets

Available grades

Silymarin NLT 80% by UV (commodity standard); Ph. Eur. 2071 refined and standardised dry extract, HPLC-assayed at a declared 30–65% nominal silymarin; USP Powdered Milk Thistle Extract grade with declared label claim; ratio-controlled grades meeting the USP flavonolignan proportions; silybin-enriched and phospholipid-complexed grades; water-dispersible and granulated direct-compression grades; organic-certified (NOP/EU) material. Purified silibinin is offered as a separate chemical article.

Packaging: 25 kg net in food-grade fibre or HDPE drums with double food-grade LDPE liners. 1 kg, 5 kg and 20 kg aluminium-foil laminate bags for samples and small lots. Nitrogen flushing on request; the powder is hygroscopic and takes up moisture from open liners. Palletised and shrink-wrapped, typically 300–400 kg per pallet.

Related products