Melatonin Tablets and Gummies

Melatonin Tablets and Gummies

N-acetyl-5-methoxytryptamine · C13H16N2O2

Finished-format melatonin in compressed tablets and pectin or gelatin gummies, 0.5-10 mg per unit, assayed at 90-110% of label claim. Synthetic non-animal active, vegan builds available.

Specifications

Active and formulaMelatonin, CAS 73-31-4; N-[2-(5-methoxy-1H-indol-3-yl)ethyl]acetamide (N-acetyl-5-methoxytryptamine). C13H16N2O2, 232.28 g/mol.
Active originMade by chemical synthesis. Non-animal and non-GMO. Off-white to pale yellow crystalline powder, melting point about 117 degrees C.
Solubility of the activeAbout 2 g/L in water at 20 degrees C, rising to about 5 g/L at 50 degrees C. In the finished unit, disintegration governs release rather than solubility.
Formats offeredUncoated or film-coated compressed tablet, and gummy on a pectin base or a bovine gelatin base. One active specification runs across both.
Strengths0.5, 1, 3, 5 and 10 mg melatonin per unit as standard. Other strengths, tablet weights and gummy piece weights to the buyer's brief.
Tablet excipient baseMicrocrystalline cellulose and dicalcium phosphate with croscarmellose sodium, silicon dioxide and vegetable-source magnesium stearate.
Gummy basePectin base keeps the piece vegan. Bovine gelatin base gives a firmer chew but makes the finished unit non-vegetarian and must be declared on pack.
Content per unit90.0 to 110.0 per cent of declared melatonin at release by validated HPLC, reported per lot on the certificate of analysis.
Uniformity of dosage unitsTablets to USP <905> / Ph. Eur. 2.9.40. Gummies controlled on piece weight and content uniformity of the finished piece.
Disintegration and moistureTablets disintegrate in not more than 30 minutes in purified water; loss on drying not more than 5.0%. Gummies held at water activity not more than 0.65.
Heavy metalsLead, arsenic, cadmium and mercury tested each lot against the destination market limits (USP <2232>, EU Reg. 2023/915 or FSSAI).
MicrobiologyTotal plate count NMT 10,000 cfu/g; yeast and mould NMT 1,000 cfu/g; E. coli, Salmonella and S. aureus absent per 10 g.
Allergen and diet statusFree from milk, egg, soy, fish, crustacean, gluten, peanut and tree nut. Vegan on the pectin build; the gelatin gummy is bovine.
Shelf life24 months unopened below 25 degrees C, protected from light and humidity.
HS codeDeclared under 21069099 as a finished supplement
Melatonin (CAS 73-31-4) is N-[2-(5-methoxy-1H-indol-3-yl)ethyl]acetamide, more often written N-acetyl-5-methoxytryptamine: an indoleamine of molecular formula C13H16N2O2 and molecular weight 232.28 g/mol. In humans it is secreted by the pineal gland on a circadian rhythm, but the material that goes into supplements is made by chemical synthesis, never extracted from animal tissue. It presents as an off-white to pale yellow crystalline powder melting near 117 degrees C, dissolving in water at roughly 2 g/L at 20 degrees C and 5 g/L at 50 degrees C. This listing is the finished unit, not the loose active. Thovek compresses melatonin into uncoated or film-coated tablets at 0.5, 1, 3, 5 and 10 mg, and deposits it into gummies on either a pectin base or a bovine gelatin base. That base decision is the one that matters commercially: pectin keeps the finished piece vegan and suits most retail positioning, while gelatin gives a firmer chew and makes the product bovine, which has to appear on the buyer's declaration and closes off several certifications. Both formats are held to the same active specification of 90.0 to 110.0 per cent of label claim by validated HPLC, with uniformity of dosage units, disintegration or water activity, heavy metals and microbiology reported on every lot certificate. The synthetic active carries no milk, egg, soy, fish, crustacean, gluten, peanut or tree-nut allergen. The allergen risk sits in the excipients instead, so glucose syrup source, colour and flavour carriers and the origin of magnesium stearate are all fixed in writing at brief stage rather than at production. One point buyers should settle early: melatonin is not treated as a food ingredient everywhere. It is a dietary supplement in the United States, while prolonged-release 2 mg melatonin has been licensed as a medicine in the European Union, Israel, Australia and several Asian markets since 2007. Confirm the position in each destination before ordering; responsibility for on-pack wording and claim substantiation stays with the brand owner in that market.

Applications

Private-label sleep tabletsPectin gummy supplementsBovine gelatin chewable gummiesBlister-packed retail tabletsTravel-format tablet packsContract manufacturing runsSleep category line extensionsBottled tablet counts

Available grades

Tablet grade: uncoated or film-coated, 0.5 to 10 mg melatonin, bottled or blistered. Gummy grade: pectin base (vegan) or bovine gelatin base, sugared or sugar-free on isomalt and maltitol, with natural colour and flavour to brief. Kosher and halal documentation can be arranged on the gelatin-free builds. Low-dose 0.5 and 1 mg tablets are held for markets that cap per-unit content.

Packaging: Bulk tablets in double food-grade LDPE liners inside HDPE drums or fibre kegs, 10-25 kg net, with desiccant. Gummies in food-grade pails or lined cartons, 5-10 kg net, nitrogen-flushed on the pectin base. Retail finishing to the buyer's artwork: alu-alu or PVDC blisters, HDPE bottles with induction seal, or PET gummy jars in 30, 60 and 90 counts. Palletised, shrink-wrapped and lot-coded, with COA, allergen statement and MSDS per shipment.

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