Melatonin
Melatonin (N-acetyl-5-methoxytryptamine) is an indoleamine found in animals, plants and microorganisms. Supplement-grade melatonin is almost always made by chemical synthesis and purified to a white crystalline powder of 99% or more. Because label amounts are in milligrams or less, brands often buy diluted triturations or granulations as well as pure powder.
Suppliers sell different products under the same name. Specify the one you need.
Synthetic crystalline powder, the main traded form.
Melatonin on a carrier (for example 1% or 10%) so small doses blend evenly.
Fine particle melatonin for fast-dissolving tablets, gummies and sublingual forms.
Melatonin pre-formulated with release-modifying excipients; regulatory treatment of these differs by market.
Compare each result with your own specification when the lot arrives.
Store sealed in light-resistant containers in a cool, dry place; melatonin degrades with light and heat. Keep pure material in controlled, labeled storage because doses are small. The supplier sets shelf life and retest, with assay and related substances repeated at retest.
Record assay and dilution for each lot and recalculate batch amounts when switching between pure and diluted grades. Keep lots traceable to finished batches and rotate first-expiry-first-out.
Facts from regulators and standards bodies, each linked to its source.
NIH's National Center for Complementary and Integrative Health states that melatonin is considered a dietary supplement in the United States.
Source: nccih.nih.gov (opens in a new tab)The same NIH page states that in several other countries melatonin is available only with a prescription and is considered a drug.
Source: nccih.nih.gov (opens in a new tab)Health Canada's Melatonin - Oral monograph lists melatonin (N-acetyl-5-methoxytryptamine) from a synthetic source; a separate monograph covers sublingual products.
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.
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 pure melatonin (99% or more), diluted triturations, micronized grades and prolonged-release granulations. Ask each supplier for the specification sheet of the exact grade they quote.
Expect assay (HPLC), related substances, identity and melting point, residual solvents, blend uniformity and heavy metals, each with its method, specification and result for that lot.
Store sealed in light-resistant containers in a cool, dry place; melatonin degrades with light and heat. Keep pure material in controlled, labeled storage because doses are small. The supplier sets shelf life and retest, with assay and related substances repeated at retest.
NIH's National Center for Complementary and Integrative Health states that melatonin is considered a dietary supplement in the United States. The same NIH page states that in several other countries melatonin is available only with a prescription and is considered a drug. Health Canada's Melatonin - Oral monograph lists melatonin (N-acetyl-5-methoxytryptamine) from a synthetic source; a separate monograph covers sublingual products.
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