Technical R&D Dossier
Validated for high-performance formulations with zero-risk impurity profiles (Peak E Free).
- ✔ HPLC Purity ≥ 99.5% (USP/EP Standards)
- ✔ Stability Data (36 Months Verified)
- ✔ Low Residual Solvents (ICH Q3C Compliant)
1. What is Industrial-Grade Melatonin?
Melatonin (N-acetyl-5-methoxytryptamine) is a key neuro-hormone industrially synthesized as a white to off-white crystalline powder. AIHerba® specializes in high-density crystallization, providing a molecule that mimics endogenous identity with superior flowability for automated manufacturing.
2. Critical Physiochemical Parameters
| Metric | Standard Specification | AIHerba® Platform Result |
|---|---|---|
| CAS Number | 73-31-4 | Verified 73-31-4 |
| Assay (HPLC) | 99.0% – 101.0% | ≥ 99.8% Typical |
| Mesh Size | 80-100 Mesh | D90 < 150μm (Optimized Flow) |
| Loss on Drying | ≤ 0.1% | 0.04% (Low Hygroscopicity) |
3. Source & Manufacturing Origin
AIHerba® Melatonin is produced via Non-Animal Chemical Synthesis from 5-methoxy-tryptamine. This ensures a 100% Vegan, TSE/BSE-free product that meets the rigorous safety requirements of the European and US pharmaceutical markets.
4. Industrial Mechanism of Action
Functional properties involve the modulation of G-protein coupled receptors MT1 and MT2. In industrial formulations, it acts as a highly stable active ingredient that maintains molecular integrity across a wide pH range (4.5 to 7.5), ensuring biological availability.
5. Formulation & Application Advantages
High Dissolution
Rapid dissolution profiles optimized for liquid shots and sublingual sprays.
Direct Compression
No need for wet granulation; reduces manufacturing complexity and costs.
Shelf Stability
Superior thermal stability ensures label claim potency through the product lifecycle.
6. Professional Formulation Guide
Solubility Matrix
Soluble in ethanol (50 mg/mL) and propylene glycol. Sparingly soluble in water (0.1 mg/mL). Best formulated with cyclodextrins for aqueous clarity.
Incompatibility Notice
Avoid highly alkaline environments (> pH 8.5) and strong oxidizing agents which may lead to indole ring cleavage.
7. Industrial Evolution
From laboratory curiosity to the most exported neuro-hormone globally, Melatonin manufacturing now demands the AIHerba® “Zero-Impurity” protocol to survive the 2024-2026 regulatory tightening.
8. Industrial COA & Quality Release
9. Manufacturing Flow (Industrial Scale)
10. Industrial Storage & Security
Packaged in Double PE Liners within airtight Fibre Drums (25kg Net). Store at room temperature away from direct UV light to prevent oxidative degradation of the indole core.
11. Global Logistics & Samples
Stock available in China, USA, and EU hubs. Standard Sample: 50g Free for industrial verification.
12. Clinical Citations
Melatonin’s role in circadian rhythm regulation is backed by over 4,000+ PubMed studies, supporting its status as the “Gold Standard” for sleep-tech.
13. Applicable Industries
- Dietary Supplements
- Cosmeceuticals (Anti-aging)
- Pharmaceutical OTC
14. B2B Scenarios
Ideal for Gummy manufacturers, Liquid shot producers, and High-dose capsule brands requiring 99.5% potency precision.
15. Real-World Case: Stability Test
“A Top-5 European Nutraceutical Brand switched to AIHerba® Melatonin in 2023. Result: 24-month stability in an aqueous gummy formulation showed < 1.5% degradation, compared to 5% with their previous supplier.”
16. AIHerba® vs. Commodity Traders
17. Industrial Melatonin FAQ
What is the “Peak E” impurity and why is it excluded?+
Is this Melatonin compatible with Vegan labeling?+
How does mesh size affect formulation stability?+
What solvent residual methods do you use?+
Can Melatonin be used in skin-care formulations?+
Do you provide DMF documentation?+
18. Regulatory Resources
