Coenzyme Q10

Coenzyme Q10 grades and forms

Coenzyme Q10 for food supplements is ubiquinone, the oxidised quinone form, bought as a crystalline powder. The declared substance is the molecule itself, so no salt or elemental factor applies. A 100 mg label claim needs 100 mg of coenzyme Q10, corrected for the assay on the certificate of analysis.

Manufacturers buy coenzyme Q10 powder in two broad types:

• Neat crystalline ubiquinone: the pure substance. It is used in softgels, hard capsules and tablets.
• Dispersible preparations: coenzyme Q10 combined with carriers such as emulsifiers or cyclodextrins, or pre-dispersed in oil. The coenzyme Q10 content is lower than in neat powder and is stated on the specification sheet.

Coenzyme Q10 for food use is made by fermentation or by chemical synthesis. The route can affect the isomer profile, and the all-trans isomer is the naturally occurring form. Ask for the production route and isomer specification in the specification sheet.

The choice of grade depends on the finished format and on whether the product needs dispersion in water. The regulatory status of any carrier in the target markets also matters. Bulk and wholesale buyers should name the grade and intended format in the quote form. SoleChem sends the specification sheet and certificate of analysis with its quote, so assay, isomer profile and carrier composition can be checked before ordering.

Ubiquinol, the reduced form, is a separate material with different handling and regulatory points. See ubiquinol vs ubiquinone and the wider coenzymes and longevity actives category.

EU regulatory status

Coenzyme Q10 is neither a vitamin nor a mineral. It does not appear in Annexes I and II of Directive 2002/46/EC. The Directive’s definition of food supplements also covers other substances with a nutritional or physiological effect. No harmonised EU list of those substances has been adopted, so member states apply their own rules alongside general EU food law.

National approaches differ. Some member states require notification, some publish lists of permitted substances and some set maximum amounts per daily portion. Check the rules of each market with its competent authority.

Under Regulation (EU) 2015/2283, a food is novel if it was not used for human consumption to a significant degree in the EU before 15 May 1997 and falls within one of the categories listed in Article 3(2)(a). Ubiquinone is generally treated as having that history in food supplements. Its status for food supplements, and for any other food category, must be confirmed before launch. Ubiquinol has its own position: check the Union list in Implementing Regulation (EU) 2017/2470. Background is in the novel food guide.

Carriers in dispersible grades are often food additives. Each must be authorised for food supplements under Regulation (EC) No 1333/2008 and meet Regulation (EU) No 231/2012. Directive 2002/46/EC requires the amount of each nutrient or substance with a nutritional or physiological effect to be declared in numerical form per portion recommended for daily consumption; see labelling a food supplement. Any claim must comply with Regulation (EC) No 1924/2006; check the EU Register and our health-claims guide.

Formulation notes

Coenzyme Q10 is lipophilic and practically insoluble in water. It dissolves in oils, which makes softgels a common format. Crystalline material suspended in oil can recrystallise, so dissolution conditions and fill stability need testing.

The low melting point shown in the data table affects processing. Heat from compression, granulation drying or hot filling can soften the powder and cause sticking to punches and equipment. Keep process temperatures low and dilute with free-flowing excipients such as dicalcium phosphate in tablets.

Ubiquinone degrades on exposure to light. Use opaque capsules and light-protective packaging, and store raw material closed and away from heat. The yellow-orange colour shows through clear shells and can stain equipment.

In capsules, neat powder can be cohesive. A flow aid such as silicon dioxide helps fill-weight consistency. Coenzyme Q10 is compatible with both HPMC and gelatin shells.

For label-claim arithmetic, divide the claim by the coenzyme Q10 content as a fraction:

• Neat powder: powder mass = label claim ÷ (assay on the certificate of analysis ÷ 100).
• Dispersible grade: powder mass = label claim × 100 ÷ stated coenzyme Q10 content in %.

Add any overage for shelf-life losses afterwards, using the overage calculator.