Melatonin
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Melatonin

Melatonin: Nature’s Sleep Regulator | Science-Backed Guide & Premium Ingredients

  1. English Name: Melatonin
  1. Specification
    • Purity: ≥ 99% (HPLC)
    • Solubility: Slightly soluble in water (0.12 g/L at 25°C), soluble in organic solvents like ethanol (5 – 10 g/100 mL), DMSO
    • Appearance – related: Loss on drying ≤ 1.0%, Heavy metals ≤ 10 ppm, Residual solvents ≤ 0.5%
    • Particle Size: Powder form usually ≤ 100 mesh; can be customized for different applications
  1. Appearance
    • White to off – white crystalline powder, odorless or with a very faint, non – chocolate – related smell
  1. CAS NO.：73 – 31 – 4
  1. Lead time: 5 – 7 Working Days
  1. Package
    • 1 kg/aluminum foil bag, 25 kg/drum (double – layer PE bag inside cardboard drum)
  1. Main Market
    • Global market, with significant demand in North America, Europe, and Asia, mainly applied in the dietary supplement, pharmaceutical, and sleep – aid industries
  1. Application Scenarios

Core Properties

  • Chemical Structure: An indoleamine with the molecular formula C₁₃H₁₆N₂O₂, synthesized from tryptophan in the pineal gland of the brain. Its structure enables it to interact with specific receptors in the body.
  • Key Features
    • Circadian Rhythm Regulation: Acts as a key regulator of the body’s internal clock, signaling the onset of nighttime and promoting the sleep – wake cycle. It helps synchronize the body’s biological rhythm with the external environment.
    • Antioxidant Activity: Exhibits strong antioxidant properties by scavenging free radicals, such as hydroxyl and peroxyl radicals. This protects cells from oxidative damage, reducing the risk of aging – related diseases and cellular degeneration.
    • Neuroprotective Effects: May help safeguard neurons from inflammation and oxidative stress, showing potential in preventing neurodegenerative disorders like Alzheimer’s and Parkinson’s disease.
    • Immune System Modulation: Influences the production and activity of immune cells, enhancing the body’s immune response during sleep and contributing to overall health.

Application Scenarios

1. Dietary Supplements

  • Sleep – Aid Supplements:
    • The most common application, available in capsules, tablets, softgels, and liquid forms, typically in dosages ranging from 0.5 – 5 mg per serving. Recommended for individuals suffering from insomnia, jet lag, or shift – work sleep disorder, it helps reduce the time it takes to fall asleep and improves sleep quality.
  • Anti – Aging Formulations:
    • Some supplements combine melatonin with other antioxidants (e.g., vitamin C, E) to target cellular aging. Its antioxidant properties support overall health and may slow down the aging process at the cellular level.

2. Pharmaceutical Industry

  • Over – the – Counter (OTC) Medications:
    • Widely sold without a prescription in many countries for short – term management of sleep problems. Regulated to ensure proper dosage and quality control, it provides an accessible solution for consumers seeking relief from sleep disturbances.
  • Clinical Research and Development:
    • Investigated for potential treatments of more complex sleep disorders, such as delayed sleep – phase disorder. Additionally, being studied for its role in managing conditions like tinnitus, due to its impact on the nervous system.

3. Cosmetics & Personal Care

  • Anti – Aging Skincare:
    • Added to night creams, serums, and masks (0.1 – 1% concentration) for its antioxidant and anti – inflammatory effects. It protects the skin from nighttime oxidative stress, promotes cell repair, and may reduce the appearance of fine lines and wrinkles.

4. Veterinary Medicine

  • Pet Sleep Supplements:
    • Used for pets experiencing sleep disturbances, such as dogs and cats with anxiety – related insomnia or those adjusting to new environments. Appropriate dosages are formulated to help pets relax and achieve better sleep.
  • Livestock Health:
    • Added to livestock feed in some cases to improve animal welfare by regulating sleep patterns, reducing stress, and potentially enhancing growth performance.

Detection Methods

  • High – Performance Liquid Chromatography (HPLC):
    • Column: C18 (250 × 4.6 mm, 5 μm), Mobile Phase: Acetonitrile – 0.1% formic acid (30:70 v/v), Flow Rate: 1.0 mL/min, Detection Wavelength: 220 nm. This method allows for accurate quantification of melatonin in various samples, ensuring product quality and consistency.
  • Liquid Chromatography – Mass Spectrometry (LC – MS):
    • Ideal for analyzing melatonin in biological samples (e.g., blood, urine), offering high sensitivity and specificity to detect trace amounts and distinguish it from other compounds.
  • UV – Visible Spectroscopy:
    • A quick – screening method for determining melatonin concentration in simple formulations, measuring the absorbance at 220 nm to estimate the amount of melatonin present.

Source & Advantages

  • Synthetic Production: Most commercial melatonin is produced synthetically through chemical synthesis, ensuring a consistent supply and high – quality product that meets market demands.
  • Cost – Effective Solution: Provides an affordable option for managing sleep disorders compared to some prescription medications, making it accessible to a wide range of consumers.
  • Global Acceptance: Widely recognized and regulated in major markets. In the US, it is sold as a dietary supplement under DSHEA; in the EU, available as a traditional herbal medicinal product or OTC medicine depending on the formulation, ensuring safety and proper use.
Categories: , , ,

Melatonin | High-Purity Natural Sleep Support Ingredient

CAS No.: 73-31-4
Appearance: White to off-white crystalline powder
Assay (HPLC): ≥99%
Source: Fermentation or synthetic origin
INCI Name: Melatonin

1. Product Overview

Melatonin is a naturally occurring hormone synthesized by the pineal gland that helps regulate the body’s circadian rhythm and sleep–wake cycle. As a bioactive ingredient, it has become a cornerstone in nutraceuticals, functional foods, and cosmetic formulations designed for relaxation, anti-stress, and anti-aging support.

AIHerba® (Shaanxi Zhonghong Investment Technology Co., Ltd.) is a GMP-certified melatonin supplier and factory with over 28 years of extraction and fermentation expertise. We offer bulk melatonin powder suitable for use in dietary supplements, beverages, sleep aid tablets, and skincare formulations.
Our melatonin extract meets international quality standards (USP/EP/CP) and is available in customized purity levels upon request.

2. Health Benefits and Functional Properties

  1. Supports Healthy Sleep:
    Helps reduce the time needed to fall asleep and improves sleep quality by synchronizing circadian rhythms.

  2. Melatonin Benefits
    Melatonin Benefits

    Jet Lag & Shift Work Recovery:
    Clinically proven to aid in re-adjusting the body’s internal clock, reducing daytime fatigue and jet lag symptoms.

  3. Antioxidant & Anti-Aging Effects:
    Melatonin acts as a potent free-radical scavenger, protecting cells from oxidative stress and promoting skin repair.

  4. Mood & Stress Balance:
    Supports serotonin and dopamine balance, contributing to a more stable mood and reduced anxiety levels.

  5. Immune Modulation:
    Emerging research suggests melatonin helps regulate immune responses and inflammatory pathways.
    (Ref: NIH, PubMed ID: 32787373; FDA Dietary Supplement Health and Education Act, 1994)

3. Traditional and Modern Applications

While melatonin was first isolated in 1958, its use as a natural sleep aid is rooted in both Western chronobiology research and traditional wellness practices focusing on balance and restorative sleep.
Today, melatonin is widely used in:

  • Dietary Supplements – Sleep aid capsules, gummies, tablets

  • Functional Beverages – Nighttime relaxation drinks

  • Cosmetics – Anti-oxidation creams, overnight masks

  • Pharmaceuticals – Prescription formulations for circadian rhythm disorders

4. Recommended Dosage & Usage Guide

Application Typical Dosage Formulation Notes
Sleep Supplements 1–5 mg per serving Combine with magnesium or L-theanine for synergistic effects
Functional Foods 0.5–3 mg per serving Use controlled release for longer duration
Cosmetic Products 0.01–0.05% Apply in evening serums or creams
Beverages 0.3–1 mg per serving Dissolves easily; stable in neutral pH

Always consult local regulatory limits before formulation.

5. Product Specifications & COA Summary

Category Item Specification Test Method
Assay Melatonin ≥99% HPLC
Appearance White crystalline powder Conforms Visual
Loss on Drying ≤0.5% USP <731>
Residue on Ignition ≤0.1% USP <281>

Pesticide Residue (mg/kg)

Item Limit Method
DDT ≤0.05 GC-MS
BHC ≤0.05 GC-MS
Aldrin ≤0.02 GC-MS
Dieldrin ≤0.02 GC-MS

Heavy Metals (ppm)

Item Limit Method
Lead (Pb) ≤2.0 ICP-MS
Arsenic (As) ≤1.0 ICP-MS
Cadmium (Cd) ≤1.0 ICP-MS
Mercury (Hg) ≤0.1 ICP-MS

Microbiological Tests

Parameter Specification Method
Total Plate Count ≤1,000 CFU/g USP <2021>
Yeast & Mold ≤100 CFU/g USP <2021>
E. coli Negative USP <2022>
Salmonella Negative USP <2022>
Staphylococcus aureus Negative USP <2022>

6. Manufacturing Process

  1. Raw Material Sourcing: Pharmaceutical-grade precursors from verified suppliers.

  2. Fermentation / Synthesis: Controlled biotechnological process for consistent melatonin yield.

  3. Purification: HPLC separation ensuring ≥99% purity.

  4. Drying & Milling: Vacuum drying to maintain stability and prevent oxidation.

  5. Quality Control: Full-spectrum testing (identity, purity, microbial, heavy metals).

  6. Packaging: Nitrogen-sealed, light-resistant containers to protect from degradation.

7. Storage, Shelf Life & Packaging

  • Storage: Store in a cool, dry, and dark environment below 25 °C.

  • Shelf Life: 24 months in original packaging.

  • Packaging Options: 1 kg aluminum foil bag / 25 kg fiber drum.

  • Private Label & OEM: Available for customized herbal extract or free sample herbal extract evaluation.

8. Logistics, MOQ & Sampling Policy

  • MOQ: 1 kg for R&D, 25 kg for bulk purchase.

  • Samples: ≤50 g free sample available (freight collected).

  • Lead Time: 3–7 business days after order confirmation.

  • Shipping: Air express, sea freight, or CIF/DDP available worldwide.

  • Payment Terms: T/T, L/C, Western Union.

9. Applications & Target Industries

Industry Application Example
Dietary Supplements Sleep support capsules, gummies, softgels
Pharmaceuticals Circadian rhythm regulation tablets
Functional Foods & Beverages Relaxation drinks, bedtime snacks
Cosmetics & Personal Care Anti-oxidation night creams
Veterinary Health Calming and recovery formulations

10. Certifications & Quality Assurance

✅ GMP Certified
✅ ISO 9001 & ISO 22000
✅ HACCP & Kosher Certified
✅ FDA Registered Facility
✅ Third-Party COA (SGS / Eurofins available)

AIHerba® ensures traceable quality control from raw material to final packaging.
Our melatonin manufacturer facility meets stringent pharmaceutical-grade extraction standards and exports to 60+ countries worldwide.

11. Why Choose AIHerba® Melatonin Supplier

  • Factory-Direct Price: Competitive wholesale pricing for large-volume buyers.

  • GMP Certified Plant Extract for Cosmetics & Supplements.

  • Flexible OEM / ODM service for personalized formulations.

  • Technical Support & Stability Data provided with every shipment.

  • Global Export Experience with over 1,200 partner brands.

12. FAQs

Q1: Is AIHerba’s melatonin natural or synthetic?
A: We offer both fermentation-derived and synthetic melatonin options, depending on client requirements.

Q2: What purity levels are available?
A: Standard 99% HPLC; higher purity or granulated forms available upon request.

Q3: Can you provide a Certificate of Analysis (COA) and MSDS?
A: Yes, both are provided with every batch, along with third-party verification reports.

Q4: Do you offer private-label formulation services?
A: Absolutely. Our R&D team supports customized herbal extract blends and product design.

Q5: Can I buy small quantities for lab testing?
A: Yes, free sample herbal extract is available for qualified R&D partners.

13. References

  1. Reiter RJ et al. Melatonin as a Chronobiotic and Cytoprotective Agent. PubMed ID: 32787373

  2. NIH Office of Dietary Supplements – Melatonin Fact Sheet

  3. FDA – Dietary Supplement Health and Education Act, 1994

  4. Zisapel, N. (2018). New perspectives on the role of melatonin in human sleep, circadian rhythms and their regulation. British Journal of Pharmacology, 175(16), 3190-3199.

  5. Auld, F., Maschauer, E. L., Morrison, I., Skene, D. J., & Riha, R. L. (2017). Evidence for the efficacy of melatonin in the treatment of primary adult sleep disorders. Sleep Medicine Reviews, 34, 10-22.

  6. Costello, R. B., Lentino, C. V., Boyd, C. C., O’Connell, M. L., Crawford, C. C., Sprengel, M. L., & Deuster, P. A. (2014). The effectiveness of melatonin for promoting healthy sleep: a rapid evidence assessment of the literature. Nutrition Journal, 13, 106.

  7. European Food Safety Authority (EFSA) NDA Panel. (2010). Scientific Opinion on the substantiation of health claims related to melatonin and alleviation of subjective feelings of jet lag (ID 1953), and reduction of sleep onset latency, and improvement of sleep quality (ID 1953) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal, 8(2), 1467.

  8. European Pharmacopoeia (Ph. Eur.) Monograph for Melatonin.

  9. U.S. Pharmacopeia (USP) Monograph for Melatonin.

  10. Reiter, R. J., Rosales-Corral, S., Tan, D. X., Jou, M. J., Galano, A., & Xu, B. (2017). Melatonin as a mitochondria-targeted antioxidant: one of evolution’s best ideas. Cellular and Molecular Life Sciences, 74(21), 3863-3881.

  11. National Institutes of Health (NIH) Office of Dietary Supplements – Melatonin Fact Sheet for Health Professionals. (Accessed July 2024).

14. Contact Us

📧 sales@aiherba.com | info@aiherba.com | liaodaohai@gmail.com
🌐 www.aiherba.com
🏭 AIHerba® | Shaanxi Zhonghong Investment Technology Co., Ltd.
GMP-Certified Herbal Extract Factory | China

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