Pure Melatonin Powder

Pure Melatonin Powder - chemically designated N-acetyl-5-methoxytryptamine, CAS 73-31-4 - is an endogenous indoleamine hormone primarily secreted by the pineal gland in response to darkness, functioning as the body's principal circadian timing signal. Its role in sleep-wake cycle regulation is among the most extensively documented mechanisms in human chronobiology, with a clinical evidence base that spans decades of peer-reviewed research across multiple therapeutic contexts.

At Jiuyuan Biotech, we produce Pure Melatonin Powder through a validated chemical synthesis process at our cGMP and ISO 22000 certified facility in Hu County, Xi'an. Our melatonin meets both USP and European Pharmacopoeia specifications - the two most demanding reference standards in the global supplement and pharmaceutical ingredient markets. Every batch is assayed by HPLC to ≥99.0% purity, with related substance profiles documented and heavy metal content verified by AAS before the batch-specific COA is issued.

The global melatonin supplement market continues to expand beyond its traditional sleep-aid positioning, with emerging research documenting antioxidant, immunomodulatory, and neuroprotective activity that is opening new formulation territories for ingredient developers. If you are sourcing melatonin for a sleep formula, a jet lag product, a pediatric supplement, or a next-generation antioxidant blend, the specification and documentation requirements differ - and we are equipped to support all of them.

Safety & Microbiological Profile

• Mature synthesis process: Our melatonin is mainly obtained through chemical synthesis, which is mature and high in purity. The synthetic route used has a yield of up to 80%, ensuring the high efficiency and purity of the product.
• Advanced production equipment: The factory is equipped with advanced production equipment, which can support our large-scale production while maintaining the consistency and stability of the product.
• Environmentally friendly production process: We pay attention to environmental protection and reduce the impact on the environment by improving the process, such as reducing the emission of harmful by-products, etc., reducing the burden on the environment.
• Large-scale shipments: Production capacity and an efficient logistics system enable us to ensure fast and large-scale shipments to meet the needs of global customers.
• Various product forms: Accepting different forms of customization to meet the needs of various consumers.

Melatonin's biological activity extends considerably beyond its popular identity as a "sleep hormone." Its mechanistic profile spans circadian biology, antioxidant chemistry, and immunomodulation - a breadth that is driving its expansion into formulation categories well outside traditional sleep support.

Circadian Rhythm Regulation

Melatonin is the primary endogenous signal for circadian phase entrainment. Secreted by the pineal gland in response to darkness, it binds to MT1 and MT2 melatonin receptors in the suprachiasmatic nucleus (SCN) - the brain's master circadian pacemaker - to suppress wakefulness signaling and facilitate sleep onset. This mechanism is the basis for melatonin's well-established clinical utility in jet lag, shift work disorder, and delayed sleep phase syndrome.

Antioxidant Activity

Melatonin is a direct free radical scavenger with a unique "cascade" antioxidant mechanism: it neutralizes reactive oxygen species (ROS) and reactive nitrogen species (RNS) through both enzymatic and non-enzymatic pathways, and its metabolites - cyclic 3-hydroxymelatonin, AFMK, and AMK - retain antioxidant activity, creating a multi-step radical scavenging chain that most conventional antioxidants cannot replicate. This property has generated significant research interest in neuroprotective, cardioprotective, and anti-aging supplement applications.

Immunomodulatory Effects

Peer-reviewed research documents melatonin's capacity to modulate both innate and adaptive immune responses, including stimulation of natural killer (NK) cell activity and regulation of pro-inflammatory cytokine expression. This immunomodulatory profile is increasingly relevant for formulators developing immune support products that extend beyond the conventional vitamin C/zinc/elderberry paradigm.

Emerging Research Areas

A comprehensive review published in PMC characterizes melatonin as potentially "the next Vitamin D" - a reference to the expanding body of evidence for its pleiotropic health effects beyond its primary indication. Documented areas of active research include cardiovascular protection, oncostatic activity, metabolic health, and mitochondrial function support. While these do not constitute approved label claims in most markets, they inform ingredient positioning for research-grade and functional health product categories.

Dietary supplements：

Within the health product industry, melatonin is predominantly utilized in formulations aimed at improving sleep quality, alleviating jet lag, and mitigating insomnia. Its regulatory effects on circadian rhythms, antioxidant properties, and immunomodulatory actions are widely acknowledged.

Pharmaceuticals:

In several jurisdictions, melatonin is classified and regulated as a pharmaceutical agent. Its therapeutic applications include the short-term management of sleep-wake cycle disorders, such as jet lag and insomnia.

Cosmetics:

Melatonin finds application in a diverse range of cosmetic and nutricosmetic products, where it is incorporated for its potential to delay the signs of aging.

Food and Beverage Industry:

Research and development efforts are directed towards the creation of food-grade melatonin with specific functional attributes for incorporation into food, beverages, and dietary supplements.

Anti-Aging Research:

Ongoing investigations in the fields of anti-aging, neuroprotection, and tumor prevention and treatment are expanding our understanding of melatonin's potential and paving the way for future applications.

Biomedicine:

Research initiatives are focused on the synthesis and characterization of melatonin derivatives with tailored biological activities for applications within the broader field of biomedicine.

Melatonin appears deceptively simple to source - it is a single-compound synthetic active with a well-defined pharmacopoeial specification. In practice, the variance between suppliers shows up in related substance profiles, residual solvent data, and the documentation depth required for regulated market submissions.

For a high-potency active like melatonin, the related substance profile is not optional documentation - it is the data your formulation QA team needs to confirm that what is in the bag matches what is on the label.

All documentation issued in English. Translated versions for EU, Japanese, or Korean regulatory submissions available upon request.

1. We attach great importance to quality management and have multiple international certifications to ensure that the production process and product quality meet international standards.

2. Including but not limited to analytical instruments such as high-performance liquid chromatography (HPLC) and mass spectrometry (MS), these equipment are essential for purity detection and quality control of melatonin.

3. Have a team of professional scientists and technicians responsible for product research and development, quality control, and technological innovation.

4. Ensure the cleanliness and safety of the production environment, comply with environmental protection regulations, and reduce pollution and waste in the production process.

5. Provide professional customer service and after-sales support to ensure that customer needs and problems can be solved promptly.

6. Continuously invest in new technology research and development and product innovation to maintain market competitiveness.

7. Use big data analysis to optimize production processes, improve product quality and meet market demand.

Packaging Configuration

We offer three standard packaging formats, each designed around a specific order volume and transit risk profile:

Standard Transit Options:

How to Specify and Evaluate Pure Melatonin Powder

Melatonin is used at doses measured in milligrams - sometimes fractions of a milligram. At that scale, specification precision and analytical rigor matter more than they do for most botanical extracts. Here is what to verify before you commit to a supplier.

1. Confirm the Assay Method and Reference Standard "99% purity" is only meaningful if the assay method is specified. HPLC against a USP or EP reference standard is the only analytically defensible method for pharmaceutical-grade melatonin. UV-Vis assay can overstate purity due to co-eluting UV-absorbing impurities. Ask specifically: "Is your assay by HPLC, and which reference standard do you use?"

2. Request the Related Substance Profile A purity figure of ≥99% tells you what percentage is melatonin. The related substance profile tells you what the remaining ≤1% contains. For a high-potency active, the identity and concentration of individual impurities matters - particularly for pharmaceutical and pediatric applications where regulatory scrutiny is highest.

3. Verify Residual Solvent Compliance for Your Target Market Melatonin synthesis involves organic solvents. ICH Q3C residual solvent limits differ between Class 1 (prohibited), Class 2 (limit-based), and Class 3 (low-risk) solvents. Confirm which solvents are used in the synthesis process and request the GC-headspace residual solvent report.

4. Clarify Pharmacopoeial Compliance If your finished product targets the EU market, EP compliance documentation is required. If it targets the US market, USP compliance is the standard. If you operate in both markets, dual-compliance documentation saves you the cost and time of commissioning separate third-party testing. Our COA is structured to support both.

5. Understand Regulatory Status in Your Target Market Melatonin's regulatory classification varies significantly by jurisdiction. It is an OTC dietary supplement in the US, carries an EFSA-approved health claim in the EU (at 0.5 mg per serving for reduction of sleep onset time), and is classified as a prescription drug in some EU member states at higher doses. Confirm the regulatory pathway for your specific product format and dose level before finalizing your formulation.

6. Assess Photostability Provisions Melatonin is sensitive to light-induced degradation. Request information on the supplier's packaging protocol - specifically whether bulk material is packed under low-light conditions and whether nitrogen flushing is available. This is particularly relevant for sea freight shipments to tropical markets.

7. Sample Before You Scale We provide analytical samples (typically 10–50 g) with a full batch-specific COA for your internal QC evaluation. Given melatonin's high potency, even a small sample provides sufficient material for HPLC verification, melting point confirmation, and IR identification at your laboratory.

Q1: What is the difference between synthetic melatonin and "natural" melatonin? Virtually all commercial melatonin used in dietary supplements and pharmaceuticals is produced by chemical synthesis - not extracted from animal pineal glands or plant sources. The synthetic molecule is chemically identical to endogenous human melatonin (CAS 73-31-4). "Natural" melatonin claims in the supplement market typically refer to plant-derived melatonin from sources such as microalgae or certain plant species, but these represent a very small fraction of the market and are produced at significantly higher cost with lower concentration yields. Our product is pharmaceutical-grade synthetic melatonin - the same form used in USP and EP pharmacopoeial preparations.

Q2: What dose range is typically used in finished supplement products? Effective doses in clinical research range from 0.5 mg to 10 mg, depending on the application. For sleep onset support, doses as low as 0.5–1 mg have demonstrated efficacy in peer-reviewed studies - a finding that has shifted many formulators away from the historically common 5–10 mg doses toward lower-dose, more physiologically aligned formulations. The EU EFSA-approved health claim for reduction of sleep onset time specifies a dose of 0.5 mg. Formulators should align their dose selection with the regulatory framework of their target market.

Q3: Is melatonin a controlled substance or prescription drug? In the United States, melatonin is classified as a dietary supplement under DSHEA and is available OTC without prescription. In the EU, regulatory status varies by member state: it is available OTC in the UK, Ireland, and several other countries, but classified as a prescription medicine in Germany, France, and some other member states - particularly at doses above 0.5–1 mg. In Canada, melatonin is a licensed natural health product. Formulators must verify the regulatory classification in each target market before product launch.

Q4: How does melatonin perform in tablet and capsule formulations? Melatonin powder blends well with standard pharmaceutical excipients including microcrystalline cellulose, lactose, dicalcium phosphate, and magnesium stearate. Its low dose (typically 0.5–10 mg per serving) means it constitutes a small fraction of the total blend weight, making blend uniformity the primary formulation challenge. We recommend using a pre-diluted blend or granulated form for very low-dose applications (≤1 mg) to ensure content uniformity. Sublingual tablet formulations benefit from melatonin's good solubility in saliva at physiological pH.

Q5: What are the stability considerations for melatonin powder in bulk storage? Melatonin is susceptible to photodegradation under UV and visible light exposure, and shows reduced stability at elevated temperatures and high humidity. Under appropriate storage conditions - sealed, opaque container at 15–25°C, away from direct light - our material maintains ≥99% purity for the full 24-month shelf life. We provide accelerated stability data (40°C/75% RH, 6-month ICH protocol) upon request for customers with extended shelf life requirements.

Q6: Can you supply melatonin in a water-dispersible or microencapsulated form? Yes. In addition to standard crystalline powder, we offer a microencapsulated melatonin grade using food-grade cyclodextrin or maltodextrin carriers, which improves water dispersibility and provides enhanced photostability - particularly relevant for functional beverage, effervescent tablet, and stick-pack applications. Contact our technical team with your formulation requirements for a tailored recommendation.

Q7: What documentation is required for importing melatonin into the EU? For EU import as a food supplement ingredient, you will typically need: a batch-specific COA aligned with EP specifications, an SDS, a country of origin declaration, and a statement of compliance with EU Regulation (EC) No 1881/2006 (contaminants) and Directive 2002/32/EC where applicable. Some EU member states require additional notification or authorization for melatonin products above specific dose thresholds. We provide a full EU documentation package and can support your regulatory filing process through our network of EU regulatory affairs consultants.

Q8: Do you offer custom particle size or granulated melatonin grades? Yes. Custom particle size specifications, granulated grades for improved flowability, and pre-diluted blends (melatonin dispersed in a food-grade carrier at a defined concentration) are available for orders meeting minimum volume thresholds. Custom grade requests are reviewed by our technical team, with feasibility confirmation typically provided within 5 business days. Pre-diluted blends are particularly useful for manufacturers producing very low-dose (0.5–1 mg) sublingual or chewable formats where blend uniformity is critical.

Jiuyuan Biotech manufactures and supplies Pure Melatonin Powder - CAS 73-31-4, ≥99.0% HPLC purity, USP and EP compliant - from our cGMP and ISO 22000 certified facility in Shaanxi, China. Every batch ships with a full pharmacopoeial-aligned COA, residual solvent report, and heavy metal data. Samples available from 10 g. Commercial orders fulfilled from 1 kg with 7–14 business day lead time.

Request a Quote or Sample:

Contact Us : info@jiuyuanbio.com

Direct Line: +86 029 88215052

Facility: Hu County, Xi'an, Shaanxi Province, China

✅ ISO 9001 · FSSC 22000 · cGMP · FDA Registered · USP/EP Compliant · Halal · Kosher

Jiuyuan Biotech - your analytically verified, pharmacopoeially compliant source for bulk Pure Melatonin Powder.