Bulk Melatonin Powder (Pure Synthetic / Ultra-High Purity ≥99.5%)

Pharma-Grade Precision · Zero Animal Origin or Transmissible Spongiform Contaminants · Exceptional Batch Consistency for Micro-Dosing Formulations

Guaranteed Pure HPLC ≥99.5% Superior Blend Uniformity (Micronized) Strict Heavy Metal & Impurity Control ISO, Kosher & Halal Certified

R&D Insights: Master the Art of Micro-Dosing Content Uniformity

Technical field notes from our chemical synthesis & solid-dose formulation engineers.

Melatonin formulation comes with a distinct industrial challenge: micro-dosing precision. Because active dosage per tablet, gummy, or capsule typically ranges from a tiny 0.5 mg to 10 mg, achieving strict Content Uniformity (CU) across millions of finished units is difficult. Coarse raw powders tend to segregate during dry blending, leading to potency spikes or sub-potent finished batches that fail QA release.

Our production process overcomes this through ultra-controlled crystallization coupled with customized particle size engineering (100% passing 100 Mesh). This delivers a silky, non-electrostatic powder that blends homogeneously with excipients like MCC or starch. The result is total peace of mind for your R&D team, zero segregration in high-speed rotary presses, and consistent assay results batch after batch.

Technical Specifications

Chemical Name & CAS Number	N-[2-(5-Methoxy-1H-indol-3-yl)ethyl]acetamide \| CAS: 73-31-4
Molecular Formula & Weight	C13H16N2O2 \| 232.28 g/mol
Assay / Purity Grade	≥ 99.5% Pure Melatonin (HPLC) \| Complies with USP / EP Pharmacopeial Standards
Physical Appearance & Melting Point	Off-White to Crystalline Powder; Odorless; Melting Range: 116.0°C – 120.0°C
Particle Size / Mesh Specifications	100 Mesh (Micronized available upon request for liquid/spray formulations)
Solvents & Related Impurities	Individual Impurity ≤ 0.1% \| Total Impurities ≤ 0.5% \| Meets USP Class 2/3 Residual Solvent limits
Heavy Metals & Contaminants	Total Heavy Metals < 10 ppm \| Pb < 1.0 ppm \| As < 1.0 ppm \| Cd < 0.5 ppm \| Hg < 0.1 ppm
Microbiological Control	Total Plate Count < 1,000 cfu/g \| Yeast & Mold < 100 cfu/g \| E. coli & Salmonella: Negative
Storage & Shelf Life	36 Months in tight, light-resistant fiber drums or aluminum bags stored at controlled room temperature (<25°C).

Why Global Supplement Brands Trust Our Melatonin Raw Material

1. Pure Non-Animal Synthesis (100% Safe)

Unlike bovine pineal extracts of the past, our Melatonin is 100% bio-chemically synthesized. Completely free from TSE/BSE risks, viral vectors, or animal-derived allergens.

2. Superior Blend Uniformity for Micro-Dosing

Engineered particle size ensures smooth distribution in low-dose premixes (1mg to 5mg), avoiding segregation during high-speed tableting and capsule filling.

3. High-Speed Processing & Low Static

Our crystalline structure minimizes static clinging on hoppers, punch faces, and dosing nozzles, dramatically cutting downtime in high-speed contract manufacturing lines.

4. Audit-Ready Global Compliance Document Pack

Every shipment arrives with comprehensive documentation-including HPLC assay chromatograms, heavy metal ICP-MS reports, and residual solvent clearances.

Application Scenarios & Formulation Solutions

Pectin & Gelatin Sleep Gummies

Dissolves smoothly in warm syrup bases without thermal degradation under standard process temperatures. Excellent stability when paired with L-Theanine or Chamomile extract.

Fast-Melt & Sublingual Tablets

Ideal particle size for fast disintegration formulations. Neutral flavor profile makes it simple to mask in mint, berry, or citrus oral melt applications.

Liquid Oral Drops & Sublingual Sprays

Easily soluble in ethanol or propylene glycol co-solvent systems for crystal-clear liquid preparations that won't precipitate during shelf life.

Extended-Release Two-Stage Capsules

Compatible with enteric and time-release polymer coatings to create dual-action sleep formulas (immediate release for sleep onset + delayed release for sleep maintenance).

Formulator & Procurement Feedback

★★★★★

"We produce millions of 3mg sleep gummies every month. Content uniformity used to give us headache during quality checks, but their micronized grade blends perfectly into our syrup matrix without hot spots."

- Lead Formulator, North American Gummy Manufacturer

★★★★★

"Their purity documents are rock solid. HPLC assays consistently test over 99.7% with zero detectable residual solvents. Passed our EU regulatory audit with flying colors."

- QA Director, European Dietary Supplement Brand

★★★★★

"Fast sample delivery, competitive tiered pricing, and very light-protected packaging. The double aluminum foil barrier ensures zero degradation during transit."

- Sourcing Manager, Global Health Product Group

★★★★★

"Their technical team was very helpful when we were optimizing solvent ratios for our new sleep spray line. Outstanding customer support from real experts."

- R&D Specialist, Contract Nutraceutical Packer

Quality System & Compliance Standards

✓ ISO Certified Facilities

Synthesized in high-standard Cleanroom (Class 100,000) environments under strict ISO 22000protocols. Certified Kosher and Halal.

✓ Full Analytical Clearance

Every batch undergoes rigorous HPLC assay testing, GC residual solvent analysis, ICP-MS heavy metal screening, and micro pathogen clearance.

Packaging Specifications & Global Logistics

Industrial Packaging Options

• Lab R&D Samples: 100g – 1 kg light-proof, vacuum-sealed aluminum foil bags.
• Commercial Bulk Drums: 25 kg fiber drums lined with double-layer protective PE bags to shield against humidity and light oxidation.

Global Air & Ocean Freight

• Express Air Sample Dispatch: DHL/FedEx courier within 24–48 hours.
• Bulk Commercial Shipments: Door-to-door air freight and ocean shipments accompanied by full export documentation (COA, SDS, Certificate of Origin).

Frequently Asked Questions (FAQ)

Q1: Is your Melatonin powder synthetic or natural extracted from animal glands?

A: Our Melatonin is 100% pure synthetic. Natural animal-sourced melatonin (historically taken from pineal glands) carries risks of viral or prion contamination. Pure chemical synthesis provides ultimate safety, higher purity (≥99.5%), and full regulatory acceptance worldwide.

Q2: How do you solve the Content Uniformity issue in micro-dosed supplement formulations?

A: We offer specialized particle sizing (100 mesh standard and custom micronized grades). By eliminating coarse granules and controlling static charge, our material disperses evenly during dry blending, ensuring every finished tablet or gummy gets its exact target dose.

Q3: How sensitive is Melatonin to heat and light during processing?

A: Melatonin is reasonably stable under typical manufacturing conditions, with a melting point around 116°C–120°C. However, prolonged exposure to UV light or extreme temperatures can cause discoloration or mild degradation. We recommend light-resistant storage and adding it during the cool-down phase when making gummies or liquid preparations.

Q4: What is the solubility of your Melatonin powder in water and solvents?

A: Melatonin is slightly soluble in water (around 0.1 mg/mL at room temperature), but dissolves readily in ethanol, propylene glycol, or hot water solutions. For liquid or spray formulas, our technical team can share recommended co-solvent blending guidelines.

Q5: How can our lab or procurement team request evaluation samples?

A: Simply complete the inquiry form below or get in touch with our sales team directly. We will send a 50g–100g trial sample kit along with a full batch COA, SDS, and technical datasheets within 24–48 hours.

Elevate Your Sleep & Wellness Formulas with Pure Melatonin Powder

Pharma-grade HPLC ≥99.5% purity, engineered particle size for micro-dosing uniformity, zero animal contaminants, and global regulatory support. Contact us today.

Request Wholesale Quote & Technical Sample Kit

Hot Tags: Melatonin Powder, China Melatonin Powder suppliers, manufacturers, factory