Policosanol Tablets

Policosanol Tablets

Sugar cane wax long-chain aliphatic alcohols · octacosanol-led C24-C34 fraction

Tablets of sugar cane wax policosanol, a C24-C34 primary aliphatic alcohol mixture led by 1-octacosanol and profiled by GC. Bulk powder also supplied. Vegan, gluten-free, made in India.

Specifications

Principal component1-Octacosanol (C28), CAS 557-61-9, C28H58O, molecular weight 410.77, melting point 83 °C
Other constituent alcoholsTriacontanol (C30), hexacosanol (C26), dotriacontanol (C32), tetracosanol (C24), heptacosanol, nonacosanol and tetratriacontanol; backbones span roughly C24 to C34
Reference profileSugar cane wax policosanol runs about 66% octacosanol, 12% triacontanol and 7% hexacosanol, with the remaining minor alcohols making up the balance
Trade standardisationTotal policosanol 90% or 95% minimum with octacosanol declared separately, commonly 50-60% minimum. Both figures must be written into the purchase specification, not one alone
AssayTotal alcohol content and chain distribution by gas chromatography, GC-FID or GC-MS, with the individual C24 to C34 alcohols reported on the certificate of analysis
Botanical sourceSaccharum officinarum sugar cane wax as standard; rice bran wax from Oryza sativa on request. The wax source is named on the certificate
Sources not usedBeeswax-derived policosanol is of insect origin and not vegan; wheat germ-derived material raises a gluten question. Thovek supplies the sugar cane route as standard
Appearance and solubilityWhite to off-white waxy powder or flakes. Practically insoluble in water, soluble in hot non-polar solvents; hydrophobic, low bulk density and poor flowing
Formulation noteGranulated with a soluble carrier before compression. Direct compression of neat policosanol gives poor content uniformity and is the usual cause of a failed pilot batch
Tablet buildStrength fixed by the approved formula; uncoated or film-coated with vegan-compatible coating systems available. Content uniformity, hardness and disintegration tested per lot
Regulatory statusWHO ATC code C10AX08. Registered as a medicine in parts of the Caribbean and Central and South America, a supplement ingredient elsewhere - confirm status per destination
Allergen statusNo milk, egg, fish, crustacean, soy, peanut, tree nut or gluten input on the sugar cane route. Vegan and vegetarian on a vegan-compatible excipient and coating system
Storage and shelf lifeBelow 25 °C in a dry place away from direct light. 24 months from manufacture in the unopened alu-alu blister or HDPE bottle, stability data on request
HS code21069099 as finished tablets. Bulk policosanol powder classifies in 38237090 - see the classification note
Policosanol is a generic name for a mixture of very long chain primary aliphatic alcohols refined from plant wax, with carbon backbones running from about C24 to C34. Its lead component is 1-octacosanol, CAS 557-61-9, C28H58O, molecular weight 410.77, melting at 83 °C - the same fatty alcohol that occurs widely in the epicuticular waxes of grasses and cereals and in wheat germ. Alongside it sit triacontanol (C30), hexacosanol (C26), dotriacontanol (C32), tetracosanol (C24), heptacosanol, nonacosanol and tetratriacontanol. The reference sugar cane wax profile is roughly 66% octacosanol, 12% triacontanol and 7% hexacosanol with the balance made up of the minor alcohols, and commercial standardisation is normally written as total policosanol of 90% or 95% minimum with octacosanol declared separately, commonly at 50-60% minimum. That second figure matters more than buyers expect. Because policosanol names a profile rather than a molecule, two lots both truthfully labelled "policosanol 90%" can carry materially different octacosanol contents, so the specification has to fix total alcohol content and the individual chain distribution, both determined by gas chromatography. The wax source is not a detail, it is a declaration. Sugar cane wax from Saccharum officinarum is the reference material and is what Thovek supplies: the wax is recovered as a by-product of cane processing, hydrolysed or saponified, the unsaponifiable alcohol fraction separated, then solvent fractionated and recrystallised to the declared profile. Policosanol is also manufactured from rice bran wax, from beeswax and from wheat germ, and those routes are not commercially interchangeable. Beeswax-derived policosanol is of insect origin and cannot be sold as vegan; wheat germ-derived material raises a gluten question that a supplement brand should not have to answer after launch; rice bran wax and sugar cane wax are both vegan and gluten-free. Anyone quoting policosanol without naming the wax is leaving the buyer's allergen and diet declarations undefined. On the tabletting side, policosanol is a waxy, hydrophobic, low-density powder with poor flow, so it is granulated with a soluble carrier before compression; attempting direct compression of the neat material gives poor content uniformity, and that is the single most common cause of a failed first pilot batch on this ingredient. Regulatory status varies by market more than for most nutraceutical ingredients. Policosanol carries the WHO ATC code C10AX08 and is registered as a medicine in parts of the Caribbean and Central and South America, while in other markets it trades as a supplement ingredient - the same chemical material, two entirely different regulatory files, and a brand cannot assume its home-market status travels. Claim wording must be checked against the destination market's authorised-claims list before artwork is signed off; Thovek supplies identity, specification and analysis only and makes no health claim of its own. On the sugar cane route the allergen picture is clean, with no milk, egg, fish, crustacean, soy, peanut, tree nut or gluten input, and the finished tablet is vegan and vegetarian where a vegan-compatible coating and lubricant system is used. Note finally that the finished tablet and the bulk powder do not share a tariff code, which is set out in the classification note below.

Applications

Private-label heart-category tabletsContract tablet manufacturingBulk powder for reformulationSoftgel and capsule fillsSports and endurance formulasPharmacy own-label linesVegan supplement rangesCombination cardiovascular formulas

Available grades

Supplement grade tablets to a declared policosanol strength, and bulk sugar cane wax policosanol at 90% or 95% minimum total alcohols with octacosanol declared separately at 50% or 60% minimum. Rice bran wax route on request. Full GC chain distribution on every certificate. FSSAI-licensed GMP manufacture with HACCP and ISO 22000; halal and kosher documentation on request. Vegan, vegetarian and gluten-free.

Packaging: Finished tablets in alu-alu blisters of 10, 15 or 30 in printed mono-cartons with leaflet, or 30/60/90/120-count HDPE bottles with induction seal, desiccant and optional child-resistant cap. Bulk policosanol powder in 25 kg fibre drums with double food-grade LDPE liner, or 5 kg and 10 kg aluminium foil laminate bags inside cartons, kept sealed because the waxy powder picks up static and fines. Export packing with shipping marks, batch numbers and manufacturing and expiry dates on each unit.

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