Bilberry and Lutein Eye Capsules

Bilberry and Lutein Eye Capsules

Vaccinium myrtillus L. fruit extract with marigold lutein - two standardised actives in one capsule

Capsules pairing refined bilberry fruit extract at 25% anthocyanidins with marigold lutein, each bought on its own assay. Vegan HPMC or gelatin shell, HPLC-fingerprinted per lot, made in India.

Specifications

CompositionTwo declared actives - refined bilberry fruit extract and marigold lutein - each specified on its own assay, with per-capsule strengths fixed by the approved formula
Bilberry identityVaccinium myrtillus L., fruit; family Ericaceae. Species confirmed against V. corymbosum and V. uliginosum on every lot
Bilberry standardisation25% anthocyanidins, the same material also quoted as 36% anthocyanosides; UV and HPLC figures both reported on the certificate of analysis
Pharmacopoeial referencePh. Eur. 07/2008:2394, fresh bilberry fruit dry extract, refined and standardised - 32.4 to 39.6% anthocyanins as cyanidin 3-O-glucoside chloride
Drug-to-extract ratio153-76:1 on the Ph. Eur. refined grade, extraction solvent methanol 70% V/V, with residual solvent controlled to the pharmacopoeial limit
Anthocyanin profile3-glycosides of delphinidin and cyanidin dominate, with petunidin, peonidin and malvidin following; profile reported as a fingerprint, not a single number
Adulteration controlHPLC and HPTLC fingerprint on every lot. UV colour alone is not accepted, because black rice, mulberry, soybean hull and azo dyes can meet a UV number
Lutein componentMarigold lutein, CAS 127-40-2, C40H56O2, MW 568.87, from saponified Tagetes erecta L. oleoresin; cold-water-dispersible beadlet at 5%, 10% or 20%
Zeaxanthin co-fractionZeaxanthin, CAS 144-68-3, travels with marigold lutein at 2 to 9% of the carotenoid fraction and is declared wherever the label carries it
Optional nutrientsVitamin A as retinyl acetate or palmitate, riboflavin (CAS 83-88-5) and zinc are the usual additions, and are the parts that can carry an EU vision claim
Capsule shellVegan HPMC by default, bovine gelatin on request; size 0 or 1, printed or plain. The shell choice decides the dietary status of the finished unit
AppearanceDeep purple to purple-black free-flowing blend flecked orange from the lutein beadlet, filled into an opaque or coloured shell to keep light off the anthocyanins
Allergen and originVegan and vegetarian on the HPMC shell. Free from milk, egg, soy, fish, crustacean, gluten and nuts. Bovine only where a gelatin shell is specified
Shelf life24 months below 25 C in the sealed pack, away from light and humidity.
HS code21069099 as a finished supplement
Bilberry, Vaccinium myrtillus L., is a small dark European berry whose commercial value sits almost entirely in its anthocyanins. Fourteen to fifteen of them have been characterised in the fruit, dominated by the 3-glycosides of delphinidin and cyanidin with petunidin, peonidin and malvidin behind them. The trade grade is the refined extract standardised to 25% anthocyanidins, which the same material is also quoted as 36% anthocyanosides, and the pharmacopoeial reference point is the European Pharmacopoeia monograph on fresh bilberry fruit dry extract, refined and standardised (07/2008:2394). That monograph requires 32.4 to 39.6 per cent anthocyanins calculated as cyanidin 3-O-glucoside chloride, on a drug-to-extract ratio of 153-76:1 using methanol 70% V/V. Anything sold as bilberry 25% that cannot show the chromatographic pattern behind that number is not the same product. Bilberry is one of the most adulterated botanicals in the trade, because cheaper anthocyanin sources - black rice, mulberry, black soybean hull, elderberry, and in the worst cases synthetic azo dyes - can hit a UV colour number without carrying the bilberry fingerprint. Every lot here is identified by HPLC and HPTLC against the anthocyanin profile rather than by total-colour UV alone, and the species is confirmed to exclude the cultivated blueberry Vaccinium corymbosum and the bog bilberry V. uliginosum. The second active is marigold lutein (CAS 127-40-2, C40H56O2, MW 568.87) from saponified Tagetes erecta L. oleoresin, supplied as a cold-water-dispersible beadlet at 5%, 10% or 20% so that it blends and flows as a dry powder instead of fighting the encapsulator, and carrying its naturally co-occurring zeaxanthin (CAS 144-68-3) at 2 to 9% of the carotenoid fraction. The two actives are declared separately on the label because they are bought on different assays and neither stands in for the other; the ratio, and any vitamin A, riboflavin (CAS 83-88-5) or zinc placed alongside them, is fixed by the approved formula. Shell is vegan HPMC by default, which keeps the whole capsule plant-based, with bovine gelatin available where a buyer prefers it. Neither bilberry anthocyanins nor lutein holds an authorised EU health claim, so European labels that need a claim carry it on vitamin A, riboflavin or zinc, each of which has an authorised claim for contribution to the maintenance of normal vision. Anthocyanins are light-, heat- and pH-sensitive, so the blend is processed cold, kept dry and packed opaque.

Applications

Private-label eye capsulesContract capsule manufacturingScreen-fatigue consumer rangesHerbal vision formulasPractitioner-channel eye SKUsPharmacy own-label rangesBotanical antioxidant blendsVegan supplement portfolios

Available grades

Health-supplement grade finished capsule. Bilberry component available as the Ph. Eur.-pattern refined extract at 25% anthocyanidins, or at 1%, 5%, 10% and 15% anthocyanins by UV as cyanidin-3-O-glucoside for cost-driven builds. Lutein component as 5%, 10% or 20% cold-water-dispersible beadlet, with declared zeaxanthin where required. Shell as vegan HPMC or bovine gelatin. FSSAI-licensed GMP manufacture with HACCP and ISO 22000; gluten-free; non-GMO and vegan declarations available on the HPMC shell; halal and kosher on qualifying builds.

Packaging: Alu-alu blisters of 10, 15 or 30 capsules in printed mono-cartons with leaflet, or 30/60/90/120-count HDPE bottles with induction seal, silica-gel or molecular-sieve desiccant and optional child-resistant cap. Opaque packs only: anthocyanins fade under light and shift colour with humidity, so clear PET is not offered on this SKU. Unpacked bulk capsules ship in double food-grade LDPE liners inside 20-25 kg fibre drums with desiccant. Cartons and bottles are shrink-wrapped into 5-ply export corrugated shippers, strapped and palletised on ISPM-15 heat-treated pallets, batch-coded with manufacture and expiry at every packaging level.

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