Coenzyme Q10 Softgels

Coenzyme Q10 Softgels

Ubidecarenone softgel · 30 to 300 mg per capsule

Softgels of fermentation-derived all-trans ubidecarenone dispersed in a lipid carrier, 30 to 300 mg strengths at USP assay. Vegan or bovine shell declared, private label and contract manufacture from India.

Specifications

Product formatSoft gelatin capsule; the active is dispersed or solubilised in a lipid carrier before encapsulation. Standard strengths 30, 60, 100, 150, 200 and 300 mg CoQ10 per capsule
Active identityUbidecarenone (INN), also coenzyme Q10 or ubiquinone-10; CAS 303-98-0; C59H90O4; MW 863.34; 2,3-dimethoxy-5-methyl-6-decaprenyl-1,4-benzoquinone
Assay of the activeNot less than 98.0% and not more than 101.0% ubidecarenone on the anhydrous basis, the USP Ubidecarenone monograph limit; label strength calculated on assayed active
Isomer profile and routeAll-trans only, from microbial fermentation. Chemical synthesis routes can carry cis isomers, so the manufacturing route is stated on every certificate of analysis
Physical data of the activeOdourless, tasteless crystalline powder, light to dark orange; melting range 49-51 C; practically insoluble in water, very slightly soluble in ethanol
Carrier systemRice bran oil, medium-chain triglycerides or sunflower oil with lecithin and a suspending wax. Soybean oil or soy lecithin only where the buyer accepts a soy declaration
Crystal state of the fillA standard suspension fill still carries undissolved CoQ10 crystals; a heat-solubilised (crystal-free) fill holds the active in solution. They are not interchangeable
Ubiquinol optionReduced form ubiquinol, CAS 992-78-9, C59H92O4, MW 865.4, encapsulated under nitrogen with an antioxidant system; it oxidises back to ubiquinone on air exposure
Co-activesBuilt to the buyer's approved formula; common partners are vitamin E, an omega-3 oil or L-carnitine. Each added active is assayed and declared separately
Shell compositionBovine gelatin, glycerol and purified water as standard; vegetarian modified maize starch and carrageenan shell for a vegan build; fish gelatin available. Opaque preferred
Allergen statusThe fermentation-derived active is free of milk, egg, fish, crustacean, gluten and nut. Soy lecithin or soybean oil in the carrier, if used, is a declarable soy allergen
Dietary and origin statusThe active is vegan (microbial fermentation, no animal input). The finished softgel is vegan only with the vegetarian shell; a bovine gelatin shell makes it non-vegetarian
Microbiology and metalsMicrobial criteria to USP <2021> and <2022> for dietary supplements; lead, arsenic, cadmium and mercury by ICP-MS against USP <2232> limits, reported per batch
Shelf life and storage24 months unopened below 25 C, protected from light and moisture. CoQ10 is light-sensitive: use opaque HDPE bottles or Alu-Alu blister rather than clear PVC film
HS code2106.90 (21069099)
Coenzyme Q10 is ubidecarenone (INN), CAS 303-98-0, C59H90O4, MW 863.34, chemically 2,3-dimethoxy-5-methyl-6-decaprenyl-1,4-benzoquinone: a benzoquinone head carrying a ten-unit isoprenoid tail, which is where the 10 in the name comes from and why the molecule behaves like a lipid rather than a vitamin. Thovek fills it as a soft gelatin capsule at 30, 60, 100, 150, 200 and 300 mg of declared active. The raw material is made by microbial fermentation, which yields the all-trans isomer only; chemical synthesis routes can leave cis isomers behind, so the manufacturing route is stated on the certificate of analysis. Assay follows the USP Ubidecarenone monograph at not less than 98.0% and not more than 101.0% on the anhydrous basis, and the declared per-capsule strength is calculated on assayed active rather than on as-weighed powder. The softgel is not a packaging preference, it is a formulation decision. Ubidecarenone is an odourless, tasteless orange crystalline powder melting at about 49-51 C and practically insoluble in water, so a dry powder in a two-piece capsule presents the body with crystals that have to be dissolved before anything can happen. A softgel disperses or solubilises the active in a lipid carrier before encapsulation - rice bran oil, medium-chain triglycerides or sunflower oil with lecithin and a suspending wax. Two distinct fills exist and are not interchangeable: a standard suspension, which still carries undissolved CoQ10 crystals, and a heat-solubilised or crystal-free fill, in which the active is taken into solution at fill temperature and held there by the carrier system. The reduced form, ubiquinol (CAS 992-78-9, C59H92O4, MW 865.4), is a separate build encapsulated under nitrogen with its own antioxidant system, because it reverts to ubiquinone on air exposure. Origin, allergen and claim status are all decided by choices made outside the active. Fermentation CoQ10 uses no animal input and is vegan in itself, but the finished softgel is vegan only when the vegetarian shell of modified maize starch and carrageenan is used; a bovine gelatin shell makes the unit non-vegetarian, and fish gelatin makes it marine. The active is free of milk, egg, fish, crustacean, gluten and nut, but soybean oil or soy lecithin in the carrier system is a declarable soy allergen, so the carrier must be specified rather than left to the plant. CoQ10 is light-sensitive, which argues for opaque bottles or Alu-Alu blister rather than clear PVC. Finally, label copy needs care: the EU authorised-claims register carries no coenzyme Q10 entry equivalent to the EPA and DHA heart-function entry, so permitted wording has to be confirmed market by market before artwork is signed off.

Applications

Private-label softgel brandsContract softgel manufacturingPharmacy own-label rangesHealthy-ageing product linesSports-nutrition support SKUsPractitioner-channel rangesE-commerce subscription SKUsExport distributor supply

Available grades

Health-supplement grade. Fermentation-derived all-trans ubidecarenone at USP assay (98.0-101.0% anhydrous basis) in suspension or heat-solubilised crystal-free fills; ubiquinol grade on request. Vegetarian modified-starch and carrageenan shells (vegan), bovine gelatin or fish gelatin. FSSAI-licensed GMP softgel manufacture with HACCP and ISO 22000; halal, kosher, non-GMO and gluten-free declarations available. Soy-free carrier available on request.

Packaging: Induction-sealed opaque HDPE bottles of 30, 60, 90 and 120 softgels with silica-gel desiccant and optional child-resistant caps, or Alu-Alu blisters of 10 or 15 in printed mono-cartons with the buyer's leaflet; opaque or Alu-Alu is specified in preference to clear PVC because ubidecarenone is light-sensitive. Bulk softgels for buyers who bottle locally are supplied in double food-grade LDPE liners inside 20-25 kg fibre drums or HDPE kegs with desiccant. Master cartons are shrink-wrapped, strapped and palletised on ISPM-15 heat-treated pallets and batch-coded at bottle, carton and pallet level. Store below 25 degrees C in a cool, dry place away from direct light.

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