Nicotinamide Riboside Hydrogen Malate

The material is traded essentially as a single specification at 98 percent minimum assay expressed as the salt, with the nicotinamide riboside content stated separately as a percentage, and with nicotinamide, nicotinic acid, free malic acid and residual solvents controlled as related substances. Because nicotinamide is the degradation product that accumulates on storage, its limit and the stability data behind it are the points on which grades are actually compared.

Physical forms are a standard crystalline powder for capsule filling, a milled grade for premix blending, and a granulated direct compression grade for tablets. Coated and microencapsulated versions are made where the salt has to sit alongside hygroscopic or alkaline excipients or survive a gummy matrix. Anomeric purity is specified, only the beta anomer being the relevant species, and the stoichiometry of the salt, one malate hydrogen per nicotinamide riboside cation, is confirmed by the malate assay rather than assumed. Suppliers offering this form generally provide comparative accelerated stability data against the chloride as part of the specification package.

In the United States the established regulatory position covers nicotinamide riboside chloride, which has been the subject of new dietary ingredient notifications and GRAS notifications to FDA with no objection letters issued. A different salt is a different substance for these purposes, so a hydrogen malate form does not automatically inherit that status; a manufacturer marketing it as a dietary ingredient would rely on its own new dietary ingredient notification or on a documented basis that the salt is not a new dietary ingredient, and any use in conventional food would require an independent determination. Claims are limited to structure and function statements with the required disclaimer.

In the European Union nicotinamide riboside chloride is authorised as a novel food and entered in the Union list under Regulation (EU) 2015/2283, with the authorisation specifying the permitted preparation, the food categories and the maximum use levels. That listing is drawn in terms of the chloride, so a hydrogen malate salt is not covered by it and would itself require authorisation as a novel food before being placed on the Union market. The substance is not a food additive and carries no E number, and it is distinct from the nicotinamide and nicotinic acid forms of vitamin B3 listed as permitted nutrient sources in Annex II to Directive 2002/46/EC. Malic acid is separately an authorised food additive in the Union under the number E 296, but that authorisation concerns its use as an acidity regulator and does not extend to the nucleoside salt. No health claim relating to nicotinamide riboside has been authorised. Codex Alimentarius has no standard for the compound.