Technical aspects
Melatonin demonstrates precise physicochemical and microbiological parameters, ensuring consistent quality, purity, and formulation efficiency.
| Parameter | Value |
|---|---|
| Appearance | White crystalline powder |
| Odor & taste | Characteristic |
| Loss on drying | ≤ 0.5% |
| Residue on ignition | ≤ 0.5% |
| Melting range | 117.0–120℃ |
| Particle size | 100% pass 40 mesh |
| Heavy metals | ≤ 10 ppm |
| Arsenic (As) | ≤ 2 ppm |
| Lead (Pb) | ≤ 2 ppm |
| Cadmium (Cd) | ≤ 1 ppm |
| Mercury (Hg) | ≤ 0.1 ppm |
| Assay (melatonin) | ≥ 99.0% |
| Individual impurities | ≤ 0.1% |
| Total impurities | ≤ 0.1% |
| Total microbacterial count | ≤ 1000 CFU/g |
| Yeast & mould | ≤ 100 CFU/g |
| Escherichia coli | Negative |
| Salmonella | Negative |
| Pseudomonas | Negative |
| Staphylococcus aureus | Negative |
