Ferrous bisglycinate
Ferrous bisglycinate is a chelate in which one ferrous (iron II) ion is bound to two molecules of the amino acid glycine. It is made by reacting a ferrous iron source with glycine in water under controlled conditions, then spray-drying the solution to a gray-green to brown powder with roughly 20% iron. Brands buy it as powder or granules for tablets, capsules, gummies and fortified foods, often as a branded chelate.
Suppliers sell different products under the same name. Specify the one you need.
Spray-dried chelate with iron content stated on the specification, for capsules and dry blends.
Granulated grades that flow and compress on tablet presses without a separate granulation step.
Trademarked ferrous bisglycinate sold with the maker's own chelation data and documentation.
Chelate blended with citric acid or other carriers for drink mixes and gummies, with the carrier named on the specification.
Compare each result with your own specification when the lot arrives.
Keep ferrous bisglycinate in tightly sealed containers in a cool, dry place, away from light and moisture, because damp or warm storage speeds oxidation of ferrous to ferric iron and darkens the powder. Reseal opened bags promptly. Shelf life is set by the supplier's specification, and aged lots are usually retested for ferrous iron and moisture.
Record the total and ferrous iron results for each lot and calculate the iron dose from the actual assay. Color can vary between lots and darken with age, so check appearance on older stock used in light-colored products.
Facts from regulators and standards bodies, each linked to its source.
FDA's GRAS Notice Inventory lists GRN 19 for ferrous bisglycinate chelate, notified by Albion Laboratories, Inc. for use in foods in general as a source of dietary iron, closed on September 30, 1999 with FDA having no questions.
Source: hfpappexternal.fda.gov (opens in a new tab)Health Canada's Multi-Vitamin/Mineral Supplements monograph for natural health products lists iron (II) bisglycinate among the source ingredients for iron (Table 2).
Source: webprod.hc-sc.gc.ca (opens in a new tab)21 CFR 101.17(e) requires dietary supplements in solid oral dosage form that contain iron or iron salts as an iron source to carry a boxed accidental-overdose warning statement.
Source: ecfr.gov (opens in a new tab)21 CFR 101.9(c)(8)(iv) sets the Reference Daily Intake for iron at 18 mg for adults and children 4 years and older.
Source: ecfr.gov (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.
Manufacturer · Bengaluru, India
Indian maker of pharmaceutical ingredients and mineral salts, with plants in Hosur. Its mineral range covers calcium, magnesium, iron, zinc, copper and selenium salts and amino acid chelates.
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 standard powder, directly compressible granules, branded chelates and buffered or blended grades. Ask each supplier for the specification sheet of the exact grade they quote.
Expect iron assay, glycine content, identity and chelation, loss on drying and heavy metals and microbiology, each with its method, specification and result for that lot.
Keep ferrous bisglycinate in tightly sealed containers in a cool, dry place, away from light and moisture, because damp or warm storage speeds oxidation of ferrous to ferric iron and darkens the powder. Reseal opened bags promptly. Shelf life is set by the supplier's specification, and aged lots are usually retested for ferrous iron and moisture.
FDA's GRAS Notice Inventory lists GRN 19 for ferrous bisglycinate chelate, notified by Albion Laboratories, Inc. for use in foods in general as a source of dietary iron, closed on September 30, 1999 with FDA having no questions. Health Canada's Multi-Vitamin/Mineral Supplements monograph for natural health products lists iron (II) bisglycinate among the source ingredients for iron (Table 2). 21 CFR 101.17(e) requires dietary supplements in solid oral dosage form that contain iron or iron salts as an iron source to carry a boxed accidental-overdose warning statement. 21 CFR 101.9(c)(8)(iv) sets the Reference Daily Intake for iron at 18 mg for adults and children 4 years and older.
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