Glutathione
Glutathione is a tripeptide made of glutamic acid, cysteine and glycine. Commercial reduced glutathione is made by fermentation with yeasts such as Saccharomyces cerevisiae or Candida utilis, then extracted, purified and crystallized. Brands buy it as a white crystalline powder for capsules, tablets and powders, and some buy derivative forms such as S-acetyl glutathione or liposomal glutathione.
Suppliers sell different products under the same name. Specify the one you need.
Crystalline reduced L-glutathione, the standard form, sold at a stated minimum purity.
An acetylated derivative sold as a separate ingredient with its own specification.
Glutathione encapsulated in phospholipid liposomes, usually as a liquid or a powder on a carrier; the glutathione content is much lower than in the pure powder.
Yeast-fermented glutathione sold under brand names with the producer's own specification and GRAS notice.
Compare each result with your own specification when the lot arrives.
Store glutathione in tightly closed, lined containers in a cool, dry place away from light, ideally under nitrogen once opened, because air and moisture convert it to the oxidized form. Keep it away from flavors and finished goods, since it has a sulfur odor. Shelf life or retest date is set by the supplier's specification; reduced glutathione assay and GSSG are the key retest points.
Record reduced glutathione assay and oxidized glutathione for each lot, and note the producer for branded grades. Rotate stock FEFO.
Facts from regulators and standards bodies, each linked to its source.
GRN 293, for glutathione notified by Kohjin Co., Ltd., closed on December 22, 2009 with FDA having no questions, for use in a list of food categories including beverages, breakfast cereals, milk products and salty snacks.
Source: hfpappexternal.fda.gov (opens in a new tab)An earlier Kohjin notice, GRN 244, closed after FDA ceased to evaluate it at the notifier's request.
Source: hfpappexternal.fda.gov (opens in a new tab)Health Canada's Natural Health Products Ingredients Database lists Candida utilis and Saccharomyces cerevisiae as source materials for L-glutathione.
Source: webprod.hc-sc.gc.ca (opens in a new tab)The same entry lists fragrance ingredient and reducing agent as non-medicinal purposes, for topical use only.
Source: webprod.hc-sc.gc.ca (opens in a new tab)This is general information, not regulatory advice. Status differs by country and by how the ingredient is used, so check the rules for your product and market.
Manufacturers and distributors whose own websites say they sell it.
Distributor · City of Industry, CA
California ingredient supplier that sources branded and commodity ingredients for supplement and food makers, from amino acids and vitamins to magnesium L-threonate and a plant-based vitamin D3.
Manufacturer · New York, NY
Sells it as Setria
North American sales office of Kyowa Hakko Bio, a Japanese fermentation company. It sells branded glutathione and citicoline plus pyridoxal-5'-phosphate and vitamin K2 (MK-4) to supplement and food makers.
Suppliers are in alphabetical order and none pays to appear. Each claim is checked against the supplier’s own website on the date shown. Ask for the specification sheet and a recent COA before you order, and confirm details with the supplier.
Common forms include reduced glutathione (GSH), s-acetyl glutathione, liposomal glutathione and branded fermentation grades. Ask each supplier for the specification sheet of the exact grade they quote.
Expect identity, assay, related substances, loss on drying and residue on ignition and heavy metals and microbiology, each with its method, specification and result for that lot.
Store glutathione in tightly closed, lined containers in a cool, dry place away from light, ideally under nitrogen once opened, because air and moisture convert it to the oxidized form. Keep it away from flavors and finished goods, since it has a sulfur odor. Shelf life or retest date is set by the supplier's specification; reduced glutathione assay and GSSG are the key retest points.
GRN 293, for glutathione notified by Kohjin Co., Ltd., closed on December 22, 2009 with FDA having no questions, for use in a list of food categories including beverages, breakfast cereals, milk products and salty snacks. An earlier Kohjin notice, GRN 244, closed after FDA ceased to evaluate it at the notifier's request. Health Canada's Natural Health Products Ingredients Database lists Candida utilis and Saccharomyces cerevisiae as source materials for L-glutathione. The same entry lists fragrance ingredient and reducing agent as non-medicinal purposes, for topical use only.
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