Valerian root extract

Valerian root extract

Valeriana officinalis L. · sesquiterpenic acids 0.8% as valerenic acid

Valerian rhizome-and-root extract standardised on sesquiterpenic acids at 0.4% and 0.8% expressed as valerenic acid by HPLC. Ph. Eur.-conforming grades available. Vegan, 25 kg drums.

Specifications

Botanical identityValeriana officinalis L. sensu lato (Caprifoliaceae, formerly Valerianaceae); dried underground parts — rhizome with roots and stolons (Valerianae radix).
Marker compoundsValerenic acid, CAS 3569-10-6, C15H22O2, Mr 234.3, reported with acetoxyvalerenic acid (C17H24O4) and hydroxyvalerenic acid (C15H22O3) as sesquiterpenic acids.
Assay / standardisationSesquiterpenic acids NLT 0.4% or NLT 0.8% m/m expressed as valerenic acid by HPLC, as ordered. Specification states whether the figure is the group or the single acid.
Ph. Eur. limits, crude drugValerianae radix 07/2015:0453 — essential oil NLT 4 mL/kg and sesquiterpenic acids NLT 0.17% m/m. Cut root 07/2015:2526 — NLT 3 mL/kg and NLT 0.10% m/m.
Ph. Eur. limits, dry extractsHydroalcoholic dry extract 07/2014:1898 (ethanol 30-90% V/V or methanol 40-55% V/V) NLT 0.25% m/m; aqueous dry extract, water at NLT 60 °C, NLT 0.02% m/m.
Drug-to-extract ratioEMA well-established-use dry extract DER 3-7.4:1, ethanol 40-70% V/V; traditional aqueous dry extract DER 4-6:1. Native DER and solvent stated on each specification.
ValepotriatesValtrate, isovaltrate and didrovaltrate occur at about 0.1-2% in the drug and are thermolabile. Finished extracts carry little or none; level tested and reported.
Appearance and odourLight to dark brown fine powder with the characteristic pungent valerian odour from isovaleric acid. The odour is inherent to genuine material, not a defect.
Species substitution cautionIndian valerian / tagara is Valeriana jatamansi Jones (syn. V. wallichii DC.) — a different species, valepotriate-rich and valerenic-acid-poor. Quoted separately.
Water, ash and residual solventsLoss on drying NMT 5.0%; total ash NMT 10.0%; residual ethanol within ICH Q3C limits; methanol not used on food-grade lots.
Heavy metalsBy ICP-MS: lead NMT 3.0 ppm, arsenic NMT 2.0 ppm, cadmium NMT 1.0 ppm, mercury NMT 0.1 ppm. Tighter buyer limits quoted on request.
MicrobiologyTPC NMT 10,000 cfu/g; yeast and mould NMT 500 cfu/g; E. coli, Salmonella and S. aureus absent in the stated sample size.
Allergen and dietary statusVegan and plant-derived; not bovine, porcine or marine. Free of milk, egg, soy, fish, crustacean, tree nut, peanut, sesame, celery, mustard and gluten.
Shelf life, storage24 months sealed below 25 °C, protected from light and moisture; odour intensifies on air exposure.
HS code13021919
Valerian root extract is produced from the dried underground parts of Valeriana officinalis L. sensu lato — the rhizome together with the roots and stolons, the article the European Pharmacopoeia calls Valerianae radix. The standardisation marker is not a single molecule but a group: the sesquiterpenic acids, reported together and expressed as valerenic acid, CAS 3569-10-6, C15H22O2, Mr 234.3. The group also contains acetoxyvalerenic acid (C17H24O4) and hydroxyvalerenic acid (C15H22O3), and a specification that names only "valerenic acid" without saying whether the number is the single acid or the summed group is ambiguous. Thovek states which it is on the specification and on every certificate of analysis. The pharmacopoeial reference points are worth quoting, because the commercial 0.8% grade sits well above all of them and buyers routinely confuse the two scales. Ph. Eur. Valerianae radix (07/2015:0453) requires the whole or fragmented drug to hold not less than 4 mL/kg essential oil and not less than 0.17% m/m sesquiterpenic acids as valerenic acid; the cut drug monograph (07/2015:2526) drops those to 3 mL/kg and 0.10%. On the extract side, Valerianae extractum hydroalcoholicum siccum (07/2014:1898), made with ethanol 30-90% V/V or methanol 40-55% V/V, requires not less than 0.25% m/m sesquiterpenic acids, while the aqueous dry extract, produced with water at not less than 60 °C, requires only 0.02%. The EMA herbal monograph records the well-established-use dry extract at DER 3-7.4:1 in ethanol 40-70% V/V and traditional aqueous dry extracts at DER 4-6:1. A 0.8% concentrate is therefore a deliberately enriched hydroalcoholic article, not a pharmacopoeial default, and the aqueous and hydroalcoholic routes are chemically different products that should not be cross-substituted mid-contract. Two practical warnings. Valepotriates — valtrate, isovaltrate, didrovaltrate and relatives — occur in the drug at roughly 0.1-2%, are thermolabile and unstable, and degrade to baldrinals; well-made hydroalcoholic and aqueous extracts carry little or none, and Thovek tests and reports the level rather than staying silent on it. Separately, identity fixing matters more here than in most botanicals: "Indian valerian" or tagara is Valeriana jatamansi Jones (syn. V. wallichii DC.), a different species with a valepotriate-rich, valerenic-acid-poor profile and its own conservation pressures, and it is a common substitution in bulk trade. Thovek quotes it as a separate product and will not ship it against a V. officinalis specification. The powder carries the characteristic pungent valerian odour driven by isovaleric acid; this is inherent to genuine material, not a defect, and tablet and gummy formulators should plan coating or masking rather than reject lots for it. The extract is plant-derived and vegan, with no bovine, porcine, marine, dairy, egg, fish, crustacean, nut, sesame or gluten input.

Applications

Night-time capsule formulationsHerbal tea and infusion blendsTablet and capsule blendsFunctional beverage premixesGummy and chewable formatsTincture and liquid extractsBotanical relaxation blendsContract manufacturing bulk supply

Available grades

Hydroalcoholic dry extract at NLT 0.4% and NLT 0.8% sesquiterpenic acids as valerenic acid by HPLC; Ph. Eur.-conforming hydroalcoholic dry extract at NLT 0.25%; aqueous dry extract for alcohol-free specifications; 4:1 and 10:1 native-DER grades; water-soluble and water-dispersible formats; cut-and-sifted and powdered Valerianae radix. Valeriana jatamansi (Indian valerian, tagara) quoted as a separate product. Options: kosher, halal, non-GMO and vegan declarations, low-odour granulation, and buyer-specific heavy-metal, pesticide and valepotriate limits.

Packaging: 25 kg net in fibre or food-grade HDPE drums with double food-grade LDPE liners; 1 kg, 5 kg and 10 kg aluminium-foil laminate pouches for pilot and R&D lots. High-barrier, odour-retaining liners as standard because valerian is strongly aromatic and can taint co-stored goods; nitrogen flush and desiccant on request. Palletised and shrink-wrapped for FCL or LCL. Free 100 g samples and 1 kg trial quantities.

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