Hyaluronic Acid Capsules (Sodium Hyaluronate)

Hyaluronic Acid Capsules (Sodium Hyaluronate)

Sodium hyaluronate · fermentation-derived, oral molecular weight grades

Capsules of fermentation-derived sodium hyaluronate, non-animal and vegan, supplied in defined oral molecular weight grades. Private label and contract manufacture from India.

Specifications

IdentitySodium hyaluronate, CAS 9067-32-7, repeat unit (C14H20NNaO11)n; the free acid form, hyaluronic acid, is CAS 9004-61-9. Also traded as hyaluronan
StructureLinear glycosaminoglycan of repeating D-glucuronic acid and N-acetyl-D-glucosamine disaccharide units joined alternately by beta-1,3 and beta-1,4 glycosidic bonds
AssaySodium hyaluronate typically not less than 91-93% on the dried basis, calibrated against glucuronic acid content of not less than about 44-45%; exact limits fixed on the agreed spec
Molecular weight gradesOral grades span oligomeric and low molecular weight material below about 10 kDa, a 50-110 kDa band, and high molecular weight above 1,000 kDa. Band must be stated on the purchase spec
Source organismBacterial fermentation, normally a non-GMO strain of Streptococcus equi subsp. zooepidemicus; cells inactivated and removed, leaving a purified polysaccharide above 90% purity
Origin and dietary statusNon-animal and vegan on the fermentation route. The legacy rooster comb extraction route is avian tissue and is not vegan or vegetarian - source is stated on every certificate of analysis
EU novel food statusAn Article 4 consultation under Regulation (EU) 2015/2283 concluded that biotechnologically produced sodium hyaluronate is not a novel food in food supplements…
AppearanceWhite to off-white or pale cream powder or granules, odourless, hygroscopic, filled into a clear or coloured capsule shell as agreed
SolubilityFreely soluble in water, forming a viscous solution whose viscosity rises steeply with molecular weight; practically insoluble in ethanol and other common organic solvents
Key purity limitsProtein not more than 0.1%, loss on drying not more than 10%, pH of dilute solution about 5.0-8.5; heavy metals, residual solvents and microbiology to the agreed specification
Capsule shellVegan HPMC or bovine gelatin, size 0 or 1 typical. A gelatin shell removes the vegan and vegetarian status of the finished SKU whatever the fill is
Allergen statusNo milk, egg, fish, crustacean, soy, peanut, tree nut or gluten input. No crustacean material in the fermentation route, despite the common assumption drawn from glucosamine
Claim wordingHyaluronic acid carries no authorised health claim under Regulation (EU) 432/2012, so EU-facing copy must remain compositional and attribute no physiological effect to the ingredient
Storage, shelf lifeBelow 25 °C at RH not above 60%, away from light; 24 months in the unopened alu-alu blister or desiccated bottle. Exported as a finished supplement under
HS code21069099
Hyaluronic acid is supplied for oral use almost entirely as its sodium salt, sodium hyaluronate (CAS 9067-32-7, repeat unit (C14H20NNaO11)n), with the free acid (CAS 9004-61-9) the less common trade article. It is a linear glycosaminoglycan built from a repeating disaccharide of D-glucuronic acid and N-acetyl-D-glucosamine joined alternately by beta-1,3 and beta-1,4 bonds, and because it is a polymer rather than a discrete molecule it is bought on assay, on glucuronic acid content and on molecular weight rather than on one purity figure. Food-grade specifications in trade run to sodium hyaluronate of not less than about 91 to 93 percent on the dried basis with glucuronic acid of not less than about 44 to 45 percent - the glucuronic acid figure is the calibration basis for the assay - together with protein not more than 0.1 percent, loss on drying not more than 10 percent, and pH of a dilute solution between roughly 5.0 and 8.5. Molecular weight is the parameter buyers most often omit and most often argue about later: oral grades run from oligomeric and low molecular weight material below about 10 kDa, through the 50 to 110 kDa band, up to high molecular weight grades above 1,000 kDa, and viscosity, dissolution behaviour and cost all track it directly. Source is the second thing to fix and the one with the clearest commercial consequences. Current food-grade material is made by bacterial fermentation, usually with a non-GMO strain of Streptococcus equi subspecies zooepidemicus, the cells being inactivated and removed so that the finished ingredient is a purified polysaccharide of more than 90 percent purity. That route is non-animal, and a capsule filled with it and shelled in HPMC is genuinely vegan. The older extraction route from rooster comb is avian tissue and is not, so a specification that simply says hyaluronic acid does not answer the question a vegan brand is asking. The European Commission has confirmed, through an Article 4 consultation under Regulation (EU) 2015/2283, that biotechnologically produced sodium hyaluronate of this description is not a novel food when used in food supplements, which removes the authorisation hurdle for EU-bound business. Status still has to be confirmed for any other destination, since novel-food and permitted-ingredient lists are national instruments. As a capsule the material behaves predictably. It is freely soluble in water, giving a viscous solution whose viscosity rises steeply with molecular weight, and is practically insoluble in ethanol. It is hygroscopic enough that filling runs under controlled humidity and the pack needs a real moisture barrier - alu-alu blister or a desiccated, induction-sealed bottle rather than a plain jar. The shell decision carries the vegan claim on its own: HPMC keeps it, bovine gelatin destroys it, and no amount of fermentation-derived fill repairs a gelatin shell on a vegan SKU. Allergen status is clean, with no milk, egg, fish, crustacean, soy, peanut, tree nut or gluten input, and there is no crustacean-derived material anywhere in the fermentation route - worth stating explicitly, because buyers often assume shellfish involvement by analogy with glucosamine. On wording, hyaluronic acid has no authorised health claim under Regulation (EU) 432/2012, so EU-facing copy must stay compositional and any hydration positioning has to be handled in general marketing language that does not attribute a physiological effect to the ingredient.

Applications

Skin hydration capsulesPrivate-label beauty rangesVegan supplement linesCollagen combination formulasContract capsule manufacturingPharmacy own-label linesE-commerce supplement brandsBlister-packed export SKUs

Available grades

Fermentation-derived food-grade sodium hyaluronate in the customer's chosen molecular weight band, low, medium or high, stated on the specification and certificate of analysis. Capsule shell in vegan HPMC or bovine gelatin. Single-active or combination builds with vitamin C, collagen peptides, zinc or biotin quoted on the approved formula. Vegan, vegetarian, halal and kosher builds available on the HPMC shell route.

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 desiccant and induction seal. Bulk capsules in double food-grade LDPE liners inside HDPE drums of 25 kg for buyers packing in their own market. Bulk sodium hyaluronate powder available separately in 1 kg or 5 kg aluminium foil bags inside fibre drums. Cartons palletised, strapped and stretch-wrapped for export.

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