Melatonin Bulk Powder

Melatonin Bulk Powder - Pharmaceutical Grade Sleep Support Ingredient 

Shaanxi Nuoyuan Biotech Co., Ltd. delivers Melatonin Bulk Powder at 99% purity, Manufactured at our ISO 9001 Certified Factory, with 20,000 tons/Year processing capacity and 30,000㎡ area. Our pharmaceutical grade Melatonin (CAS 73-31-4) is tested and verified using 5 separate modern quality control methods to ensure the potency and purity of every batch.

With over 15 years of proven experience in OEM/ODM, we are trusted in providing ready-stock solutions for nutritional supplement manufacturers, pharmaceutical firms and functional food brands. Every batch is produced to rigorous Halal and Kosher certification requirements, ensuring you consistent supply, accurate micro-dosing capabilities (1-10mg formulations) and full traceability from synthesis to shipping.

What is Melatonin Bulk Powder?

This product is a high purity, pharmaceutical grade raw material (N-acetyl-5-methoxytryptamine) for producers of sleep support supplements and functional wellness products. This bulk version has none of the consumer-ready capsule packaging and allows you total control over dose, formulation and product differentiation.

Melatonin is a natural chronobiotic exogenous that adjusts your customers’ circadian cycle without the danger of dependence. Your manufacturing team can achieve consistent mixing and exact micro-dosing across tablets, gummies, drinks or capsules.

Our synthetic manufacturing method avoids any possibility of animal contamination and guarantees a constant purity level of 99%. This implies less batch rejection, easier regulatory compliance, and reduced per unit cost of your completed items.

Certificate of Analysis (COA)

Key Benefits and Applications

For Manufacturers & Brand Owners

Our homogeneous 80-100 mesh particle size means a big improvement in your production efficiency. The homogeneity permits trouble-free incorporation in capsule fills, tablet compression and beverage dispersions.

The product is used by pharmaceutical firms for insomnia medicines and circadian rhythm therapy. 99% purity reduces excipient interactions and enables clean-label claims that marketing teams require.

Health Benefits for End-Users

Your clients depend on melatonin to decrease sleep onset time by 20-30 minutes. Clinically it may be used for jet lag recovery, shift-work adaptation, and in the treatment of delayed sleep phase syndrome.

Its antioxidant qualities safeguard cell health and boost immunological function. Melatonin works naturally to reset the body’s circadian clock without the morning grogginess or the risk for addiction that comes with pharmaceutical sedatives.

Industrial Applications

Our powder is used in gummies, sublingual pills, and liquid drops by dietary supplement manufacturers. Functional food makers include it in relaxation drinks and sleep snack bars.

Cosmetic formulators harness the antioxidant effects of melatonin in anti-aging serums and nightly repair creams. Your R&D team may trial new delivery forms, from transdermal patches to dissolvable films.

Quality Control & Test Standards

We do eight quality checks, from the raw material check to the final packing. Melatonin Bulk Powder is processed by our HPLC equipment to verify potency at ±1% of specification.

Heavy metal screening is performed using ICP-MS technique that detects parts-per-billion contamination. This means you meet FDA, EU and Health Canada laws and you safeguard your brand image.

Our microbiological limit testing is performed according to the criteria of USP <2021>. We test for the presence of E. coli, Salmonella and mould types that may impact shelf stability. Residual solvent analysis using gas chromatography to validate your regulatory filings to ICH Q3C.

Third party lab verification available on request. We keep comprehensive batch records for three years to meet your traceability needs during audits.

Excellence in Manufacturing & Certification

Quality Management System ISO 9001

We have detailed procedures covering 47 essential control points in our synthesis, purification and packaging activities. Routine third-party audits ensure constant conformity with international quality standards.

Certification HALAL

Our Halal certification is provided by credible Islamic bodies and guarantees that no animal based substances have been used and that Islamic dietary regulations have been followed. This opens up markets in the Middle East and South-East Asia for your items.

Kosher Certification Agency STAR-K

Rabbinical monitoring during manufacture assures your formulas fulfil Jewish dietary laws. Enter the North American and Israeli markets with confidence.

FDA Registration 

Our facility registration (available upon request) confirms our dedication to compliance with U.S. market standards. We are compliant with current Good Manufacturing Practices (cGMP) under 21 CFR Part 111.

Flexible Packaging Options

We understand your procurement needs vary by project stage:

All packages were nitrogen flushed to avoid oxidation during storage. Moisture-barrier liners in drums keep drums stable for 24 months at storage temperatures below 25°C.

International Transportation Methods

Standard Shipping (100g - 10kg)

Samples will be sent to North America, Europe and Asia Pacific by DHL, FedEx, UPS or EMS in 3-7 working days. Follow your package in real time with complete insurance coverage.

Air Cargo (25kg plus)

Commercial quantities are available within 5-10 days at major international airports. We take care of customs documents and provide Certificates of Analysis for clearance.

Sea Freight (Above 500kg)

Ocean freight is economical and can handle high volume orders with a travel period of 20 to 35 days. Full container loads (FCL) & Less than container loads (LCL) available

DDP Services 

All Duties Paid Door to Door Paid solutions take away the burden of customs. Our team handles all tariffs, taxes and clearance processes for smooth delivery to your location.

All packing complies with IATA hazardous goods laws and international shipping requirements. Material Safety Data Sheets (MSDS) and phytosanitary certifications when applicable.

Warehouse & Shipping

Our Teams

Exhibitions

Frequently Asked Questions

Q : What is the product's minimum order quantity?

A: We can provide 100g samples for test. Commercial orders 25kg minimum, scalable for increasing companies.

Q: What do you do for continuous 99% purity from batch to batch?

A: HPLC testing is done on every manufacturing run at 3 stages – after synthesis, before packing and final release. Only shipments that meet 99.0-99.5% range ship.

Q: Can you provide custom packaging or private labeling?

A: Yes. Our OEM service includes branded package design, label printing and customised requirements. Minimum quantities apply according on customisation intricacy.

Q: What is the normal shelf life if kept properly?

A: 24 months in airtight containers, below 25°C, away from light and moisture. Refrigeration is recommended for long term stability.

Q: Can you provide technical help for formulation development?

A: You got it. Our R&D team helps you optimise your product performance with dose recommendations, solubility data and excipient compatibility testing.

Q: Which countries do you currently export to?

A: We have comprehensive regulatory paperwork assistance for our customers in 40+ countries spanning North America, Europe, South America, the Middle East and Asia-Pacific.

Contact Us

Ready to secure your supply of pharmaceutical-grade Melatonin Bulk Powder? Request your Certificate of Analysis and quote today at sales@nuoyuanbio.com.