Hey there! If you’ve ever found yourself staring at the ceiling at 3 AM, you’ve probably heard about melatonin. It’s everywhere these days, from grocery stores to online shops. But what exactly is it, how much should you really take, and where does it even come from? We’re breaking it all down for you in this simple guide.
Introduction: Why Melatonin Matters in B2B Manufacturing
Melatonin is no longer just a consumer-facing sleep supplement ingredient. For manufacturers, brand owners, and formulation teams, it has become a highly regulated, specification-driven raw material used across dietary supplements, functional foods, and select pharmaceutical research applications.
This guide is written specifically for professional buyers — procurement managers, R&D teams, product developers, and OEM partners — who need a clear, factual, and compliance-focused overview of melatonin as a raw ingredient.
Rather than making health or treatment claims, this article focuses on material properties, sourcing logic, quality benchmarks, formulation considerations, and procurement decision factors, helping buyers make informed, risk-aware choices.
1. What Is Melatonin as a Raw Material?
Melatonin (CAS No. 73-31-4) is a naturally occurring indoleamine that is also produced synthetically for industrial use. In commercial manufacturing, melatonin is supplied as a high-purity crystalline powder intended for further formulation, not for direct consumer use.
Common Industrial Characteristics
- Chemical Name: N-acetyl-5-methoxytryptamine
- Molecular Formula: C₁₃H₁₆N₂O₂
- Appearance: White to off-white crystalline powder
- Solubility: Slightly soluble in water; soluble in ethanol
- Typical Purity: ≥99% (HPLC)
In B2B contexts, melatonin is classified and handled as a functional active ingredient, requiring strict quality control and traceability.
2. Global Melatonin Sourcing: What Buyers Should Know
Synthetic Production vs. Natural Extraction
Commercial melatonin is almost exclusively synthetically produced, as natural extraction yields are extremely low and not scalable. Buyers should expect:
- Consistent molecular structure
- Better batch reproducibility
- Lower contamination risk
Key Supplier Evaluation Criteria
When sourcing melatonin in bulk, professional buyers typically assess:
- Purity consistency (HPLC)
- Residual solvent control
- Heavy metal limits
- Microbiological standards
- Batch-to-batch traceability
Reliable suppliers should be able to provide COA, MSDS/SDS, and full technical documentation upon request.
3. Quality Specifications and Compliance Expectations
Typical Specification Benchmarks
| Parameter | Industry Expectation |
|---|---|
| Assay (HPLC) | ≥99.0% |
| Loss on Drying | ≤0.5% |
| Heavy Metals | ≤10 ppm |
| Residual Solvents | USP / ICH compliant |
| Microbial Limits | Food-grade standard |
Regulatory Awareness
Melatonin regulatory status varies by region:
- United States: Regulated as a dietary supplement ingredient (FDA DSHEA framework)
- European Union: Country-specific classification; dosage and labeling restrictions apply
- Asia-Pacific: Often regulated as a functional ingredient or food supplement additive
Buyers should always verify local regulatory compatibility before commercialization.
4. Melatonin in Formulation: Industry Applications
Dietary Supplements
Melatonin is widely used in:
- Capsules & tablets
- Gummies
- Liquid drops
- Combination sleep formulas
Formulators often focus on dosage precision, stability, and uniform distribution, particularly in low-dose applications.
Functional Foods & Beverages
While technically feasible, melatonin inclusion in foods requires:
- Careful regulatory review
- Stability testing
- Controlled processing conditions
Research & Pharmaceutical Use
In R&D settings, melatonin may be used as a reference compound or formulation component, requiring higher documentation standards.
5. Procurement Considerations for Bulk Buyers
MOQ & Packaging
Typical bulk supply options include:
- 1 kg – 25 kg aluminum foil bags or fiber drums
- Custom packaging upon request
Lead Time & Logistics
- Standard lead time: 3–7 working days
- Export packaging compliant with international transport regulations
Supplier Transparency
A professional supplier should openly share:
- Manufacturing standards (GMP / ISO)
- Quality control processes
- Sample availability for evaluation
6. How to Reduce Risk in Melatonin Procurement
To minimize sourcing risks, experienced buyers:
- Request pre-shipment COA
- Conduct third-party lab verification
- Confirm regulatory alignment for target markets
- Choose suppliers with documented export experience
This approach protects both product integrity and brand reputation.
7. From Knowledge to Action: Next Steps for Buyers
If you are evaluating melatonin as a raw material for your next product line, the logical next step is to review detailed specifications, certificates, and supply terms.
👉 View Melatonin Product Specifications & COA
👉 Explore Factory Capabilities & OEM Services
👉 Submit a B2B Inquiry for Samples or Quotation
(These steps ensure a smooth transition from technical understanding to commercial decision-making.)
FAQ – Melatonin Raw Material (B2B Focus)
Q1: Is melatonin naturally sourced or synthetic in bulk supply?
Most commercial melatonin is synthetically produced to ensure purity, scalability, and consistency.
Q2: What purity level is standard for manufacturing use?
≥99% by HPLC is widely accepted for dietary supplement formulation.
Q3: Can melatonin be customized for different formulations?
Yes. Particle size, packaging, and documentation can often be customized for OEM projects.
Q4: Is melatonin suitable for functional foods globally?
Regulations vary by country; compliance review is essential before use.
Q5: What documents should suppliers provide?
COA, MSDS/SDS, technical data sheet, and origin information are standard.
Sourcing Quality: From Supplier to You
A great example is Shaanxi Zhonghui Investment Technology Co., Ltd. (aiherba.com). They operate as a professional manufacturer and supplier of high-grade ingredients. They offer services that are perfect for businesses, including:
- Free Samples of Plant Extracts: Want to test the quality before making a large order? They provide sample services so you can evaluate their products.
- Organic Plant Extract Suppliers: They can provide ingredients that meet organic standards, catering to the growing demand for clean-label products.
- Custom Plant Extract Needs: Have a specific formulation in mind? They can work with you on custom blends, concentrations, and delivery methods (like powders for capsules). Their customization process is designed to be straightforward, handling everything from initial inquiry to final production.
Where to Buy & Supplier Info:
For wholesale, bulk, or manufacturing inquiries, you can reach out to them directly.
- Supplier: Shaanxi Zhonghui Investment Technology Co., Ltd.
- Website: aiherba.com
- Email: sales@aiherba.com, info@aiherba.com, liaodaohai@gmail.com
References & Regulatory Sources
- PubMed – Melatonin chemical and biological research
- NIH – Dietary Supplement Ingredient Database
- FDA – Dietary Supplement Health and Education Act (DSHEA)
- EFSA – Novel food and ingredient assessments
- USP – Analytical standards and testing guidance
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