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.
| Active and formula | Melatonin, CAS 73-31-4; N-[2-(5-methoxy-1H-indol-3-yl)ethyl]acetamide (N-acetyl-5-methoxytryptamine). C13H16N2O2, 232.28 g/mol. |
| Active origin | Made by chemical synthesis. Non-animal and non-GMO. Off-white to pale yellow crystalline powder, melting point about 117 degrees C. |
| Solubility of the active | About 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 offered | Uncoated or film-coated compressed tablet, and gummy on a pectin base or a bovine gelatin base. One active specification runs across both. |
| Strengths | 0.5, 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 base | Microcrystalline cellulose and dicalcium phosphate with croscarmellose sodium, silicon dioxide and vegetable-source magnesium stearate. |
| Gummy base | Pectin 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 unit | 90.0 to 110.0 per cent of declared melatonin at release by validated HPLC, reported per lot on the certificate of analysis. |
| Uniformity of dosage units | Tablets to USP <905> / Ph. Eur. 2.9.40. Gummies controlled on piece weight and content uniformity of the finished piece. |
| Disintegration and moisture | Tablets 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 metals | Lead, arsenic, cadmium and mercury tested each lot against the destination market limits (USP <2232>, EU Reg. 2023/915 or FSSAI). |
| Microbiology | Total 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 status | Free from milk, egg, soy, fish, crustacean, gluten, peanut and tree nut. Vegan on the pectin build; the gelatin gummy is bovine. |
| Shelf life | 24 months unopened below 25 degrees C, protected from light and humidity. |
| HS code | Declared under 21069099 as a finished supplement |
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.
A two-active night-time tablet pairing melatonin with L-theanine, standard build 3 mg plus 200 mg, each active assayed separately at 90-110% of label claim. Vegan build on fermentation theanine.
L-theanine capsules at 100, 200 or 250 mg, not less than 98% L-form by HPLC, in vegan HPMC or bovine gelatin shells. Caffeine-free fermentation grade or tea-derived to an agreed caffeine limit.
Hard capsules filled with Withania somnifera root extract standardised to 1.5%, 2.5% or 5.0% withanolides by HPLC. Vegan HPMC or bovine gelatin shell, allergen-free fill, bulk and private label from India.