Melatonin 99%

Melatonin 99% Pure Grade – Premium Quality Sleep Support Raw Material for Global Supplement Manufacturers

Melatonin 99% is the gold standard purity in N-acetyl-5-methoxytryptamine supply and meets pharmaceutical grade standards for dietary supplement and nutraceutical formulation. Hefei Fushan Yuansheng Biotechnology Co., Ltd. supplies this high-assay neurohormone raw material using modern fermentation and semi-synthesis procedures, with great quality control and regulatory compliance. We provide reliable batches that are HPLC tested, impurities < 0.1% and heavy metals well regulated to < 10ppm. We have steady manufacturing capacity to serve big scale orders, and complete certifications like GRAS, NSF GMP and FSSC22000 to provide your business with solid, science-backed ingredients for sleep health products.

What is Melatonin 99%?

This high quality raw material has a minimum assay of 99% N-acetyl-5-methoxytryptamine, produced by complex chemical or enzymatic fermentation paths. The high-purity threshold addresses important industrial problems like 'Peak E' impurities connected to toxicological hazards and batch variability that degrades formulation efficacy. 

By attaining this purity criteria, you achieve maximal bioavailability for end-users and low chance of adverse effects.  The crystalline powder shape lends itself considerable adaptability in a number of administration modalities from controlled release tablets to liquid solutions.

Key Specifications

Physical and Chemical Properties

Melatonin 99% is an off-white to light yellow crystalline powder with the chemical formula C13H16N2O2 and a molecular weight of 232.28 g/mol. Its melting point varies from 116’C to 120’C which permits thermal stability under different processing circumstances.

Loss on Drying (LOD) is ≤0.5%, Residue on Ignition is ≤0.1%. Due to its lipophilic nature, it crosses the blood-brain barrier efficiently, resulting in a better functional effectiveness. It is marginally soluble in water, but highly soluble in ethanol and propylene glycol, which allows for formulation versatility.

Quality criteria are compliant to USP or EP monographs and ensure pharmaceutical quality.

Manufacturing Advantages

Our fermentation and semi-synthesis technology provides better purity with improved safety profiles compared to animal-derived alternatives. This is a contemporary manufacturing technology which does not present the hazards of virus contamination found in bovine pineal extracts, and is environmentally friendly.

Assay and impurity profiles are verified by HPLC, which supports rigorous quality control. Gas Chromatography Headspace (GC-HS) testing confirms Class 1 and 2 residual solvents such as methanol or toluene are not traceable. ICP-MS Heavy Metal Analysis for Lead, Arsenic, Mercury & Cadmium Compliance

Laser diffraction Particle Size Distribution (PSD) is used to ensure uniformity in tableting. Microbiological analysis complies with regulatory norms for absence of Salmonella and E. coli.

Application Scenarios

Pharmaceutical Controlled Release Formulations – As the primary API in chronotherapeutic medicines, this purity level enables accurate release kinetics over 8-10 hours with no degradation. Your formulas work all night long.

Advanced Nutraceutical Liquid Suspensions: The grade provides chemical stability in watery conditions in high-performance sleep drops. This inhibits oxidation and precipitation, preserving the integrity of the product.

Cosmetic Anti-Aging Systems: Strong antioxidant activities without skin irritation when administered in topical creams, excellent purity. Lower grade impurities might produce unfavourable responses upon exposure to UV light and complicated lipid matrices.

Dietary Supplement Tablets and Capsules: This ingredient is compatible with all dosage forms and can be easily formulated into tablets, powders and capsules for a variety of market applications.

Quality Assurance and Certifications

Our supply chain partners maintain advanced facilities certified with GMP, ISO22000, HACCP, and HALAL standards. Raw materials comply with China New Food Raw Materials regulations, US FDA GRAS requirements, and USP standards.

With 54 domestic and international invention patents and over 30 granted patents, Hefei Fushan Yuansheng Biotechnology demonstrates innovation leadership. Our R&D team, led by four PhDs, provides scientific backing for product development.

Comprehensive certifications including NSF GMP, FSSC22000, Kosher, Halal, BRC, FSMA, VeganSu, and ISCC plus ensure your formulations meet global regulatory requirements. We support your market entry with complete documentation and compliance assistance.

Frequently Asked Questions

Q:What dosage forms is this raw material suitable for?

A:All dosage forms are compatible. This ingredient works with tablets, powders, capsules, and more, widely used in dietary supplements, cosmetics, and other fields.

Q:Does this raw material support customization of other content levels?

A:Yes, customization is available. We support active ingredient content customization with a 3-7 day rapid response and shipping system established.

Q:Do you provide support for application formulations and dosage forms?

A:Water-soluble melatonin can be customized to meet diverse market needs, offering technical guidance for your specific applications.

Q:Is this product derived from animal sources?

A:No, our product is synthetic or produced via enzymatic fermentation, ensuring high purity and eliminating viral contamination risks.

Q:How is stability maintained during storage?

A:Store in light-resistant, amber-colored containers away from UV exposure. Proper storage maintains the 99% assay throughout the 24-month shelf life.

Contact Us

Ready to enhance your formulations with pharmaceutical-grade quality? Contact our Melatonin 99%'s team at info@extrabroc.com for technical specifications, samples, and customized solutions today.