Saw Palmetto Extract

Saw Palmetto Extract

Serenoa repens (W. Bartram) Small · 85–95% total fatty acids (GC-FAME)

Lipidosterolic extract of Serenoa repens berries, supercritical CO2 or solvent extracted, at 85–95% total fatty acids by GC with lauric-ratio authenticity screening. Plant-derived, not a marine oil.

Specifications

Botanical sourceSerenoa repens (W. Bartram) Small, family Arecaceae; synonym Sabal serrulata
Plant partRipe dried fruit (berry), wild-harvested from the coastal southeastern United States
ExtractionSupercritical carbon dioxide, or hexane or ethanol extraction, specified at order; solvent residues tested to the applicable ICH class limits
Total fatty acids85–95% by GC-FAME as standard; USP monograph minimum for saw palmetto extract is NLT 80%
Fatty acid profileTypically lauric 27–30%, oleic 27–30%, myristic around 10%, palmitic around 10%; eleven individual acids quantified per the USP GC-FAME method
Authenticity screeningLauric acid to individual fatty acid ratios per the USP revision for CO2 extracts, plus acid value, fatty alcohol and phytosterol profiling
PhytosterolsPresent at a fraction of a percent, principally beta-sitosterol; assayed on request
Powder gradesOil adsorbed on silicon dioxide or maize-derived maltodextrin at 25% or 45% total fatty acids; also 4:1 native ratio berry powder extract
AppearanceOleoresin: dark green to brown viscous oil with characteristic odour. Powder: off-white to light beige free-flowing powder
Adulteration controlScreened against BAPP-documented substitution with palm, palm kernel, coconut and canola oils and with synthetic free fatty acid blends
Heavy metalsLead NMT 3 ppm, arsenic NMT 2 ppm, cadmium NMT 1 ppm, mercury NMT 0.1 ppm
Microbiology (powder grades)Total plate count NMT 10,000 cfu/g; yeast and mould NMT 500 cfu/g; E. coli and Salmonella absent
Allergen and diet statusPlant-derived, vegan and vegetarian. Not a fish or marine oil. No milk, egg, soy, fish, crustacean, peanut, tree nut, coconut or gluten source
Shelf life and storage24 months for powder and 18 months for oleoresin, in unopened original packaging under nitrogen, stored cool, dry and away from light
HS code3823.19 (38231900)
Saw palmetto is the ripe dried fruit of Serenoa repens (W. Bartram) Small, a fan palm of the Arecaceae native to the coastal southeastern United States and still largely wild-harvested in Florida, Georgia and South Carolina. The commercial article is a lipidosterolic extract: the berries are dried and then extracted with supercritical carbon dioxide or with hexane or ethanol to recover the fatty acid and phytosterol fraction. Thovek supplies both the free-flowing oleoresin and carrier-adsorbed powders for dry blends. The extract is defined by its fatty acid profile. The USP monograph for saw palmetto extract sets total fatty acids at not less than 80% and quantifies eleven individual acids by GC-FAME — caproic, caprylic, capric, lauric, myristic, palmitic, palmitoleic, stearic, oleic, linoleic and linolenic. Authentic material runs roughly 27–30% lauric, 27–30% oleic, around 10% myristic and around 10% palmitic, with phytosterols including beta-sitosterol at a fraction of a percent. Our standard offer is 85–95% total fatty acids. The USP monograph revision added a set of ratios of lauric acid to the other individual acids specifically applicable to supercritical CO2 extracts, and we screen against those ratios rather than reporting a bare total. That screening matters because saw palmetto is one of the most adulterated botanicals in the trade. The American Botanical Council's Botanical Adulterants Prevention Program has documented dilution and outright substitution with cheaper palm, palm kernel, coconut and canola oils and with designer free fatty acid blends assembled to mimic the profile; its 2019 laboratory guidance document, authored by Stefan Gafner, assessed 34 published analytical methods and concluded that a combination of organoleptic inspection, acid value and GC profiling of fatty acids, fatty alcohols and phytosterols is needed to establish authenticity. A total fatty acid number alone proves nothing. On declarations: the material is entirely plant-derived, vegan and vegetarian, and buyers should note it is not a fish or marine oil despite being an oil — there is no fish, crustacean, milk, egg, soy, peanut, tree nut or gluten source in the extract itself, and authentic material contains no coconut or palm oil, which is worth stating because coconut is a declarable tree nut in the United States. Where a powder is required the carrier is silicon dioxide or maize-derived maltodextrin, declared on the specification. Softgel encapsulators should confirm their own shell material separately, since gelatin shells are commonly bovine or fish derived and that declaration belongs to the finished dose, not to this ingredient.

Applications

Men's wellness softgelsTwo-piece capsule formulationsHerbal tablet blendsCosmetic hair care activesScalp and topical serumsVeterinary supplement premixesCombination botanical oil blendsBulk contract manufacturing supply

Available grades

Supercritical CO2 oleoresin at 85%, 90% or 95% total fatty acids; hexane or ethanol extracted oleoresin at 85–90%; adsorbed powder at 25% and 45% total fatty acids; 4:1 native ratio berry powder extract. Nutraceutical grade and cosmetic grade.

Packaging: Oleoresin in 20 kg or 25 kg HDPE jerricans and 190 kg epoxy-lined steel drums, nitrogen-flushed. Powder grades in 25 kg fibre drums with double food-grade LDPE liner, and 1 kg and 5 kg foil laminate pouches for trials. Palletised and shrink-wrapped for export.

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