melatonin

Melatonin Supplementation

Melatonin Supplementation

  1. English Name: Melatonin Supplementation
  1. Specification
    • Melatonin Purity: ≥ 99% (HPLC)
    • Solubility: Slightly soluble in water (0.12 g/L at 25°C), soluble in organic solvents like ethanol, chloroform
    • Appearance – related: Loss on drying ≤ 1.0%, Heavy metals ≤ 10 ppm, Residual solvents ≤ 0.5%
    • Particle Size: Capsule – grade powder ≤ 100 μm; micronized versions ≤ 5 μm for better dissolution
  1. Appearance
    • White to off – white crystalline powder, odorless or with a faint, characteristic odor, not related to chocolate
  1. CAS NO.：73 – 31 – 4
  1. Lead time: 5 – 7 Working Days
  1. Package
    • 0.1 – 5 mg/capsule (blister packs or bottles), 1 kg/aluminum foil bag, 25 kg/drum (for bulk powder, double – layer PE bag inside cardboard drum)
  1. Main Market
    • Global market, with significant demand in North America, Europe, and Asia, mainly used in the dietary supplement, pharmaceutical, and sleep – aid industries
  1. Application Scenarios

Core Properties

  • Chemical Structure: An indoleamine with the molecular formula C₁₃H₁₆N₂O₂, produced naturally by the pineal gland in the brain.
  • Key Features
    • Circadian Rhythm Regulation: Acts as a key regulator of the body’s internal clock, signaling nighttime to the body and promoting sleep – wake cycles.
    • Antioxidant Activity: Scavenges free radicals, especially hydroxyl and peroxyl radicals, protecting cells from oxidative damage.
    • Neuroprotective: May reduce the risk of neurodegenerative diseases by protecting neurons from inflammation and oxidative stress.
    • Immune System Modulation: Regulates the production of cytokines, enhancing immune function during sleep.

Application Scenarios

1. Dietary Supplements

  • Sleep – Aid Products:
    • The most common use, available in capsules, tablets, gummies, or liquid forms (0.5 – 5 mg per serving). Recommended for individuals with insomnia, jet lag, or shift – work sleep disorder, helping to reduce time to fall asleep and improve sleep quality.
  • Anti – Aging Formulations:
    • Some supplements combine melatonin with other antioxidants (e.g., vitamin C, E) to target cellular aging, leveraging its antioxidant properties.

2. Pharmaceutical Industry

  • Over – the – Counter (OTC) Medications:
    • Sold without a prescription in many countries for short – term management of sleep problems. Regulated to ensure proper dosage and quality control.
  • Clinical Research:
    • Investigated for treating more complex sleep disorders (such as delayed sleep – phase disorder) and other conditions like tinnitus, due to its potential impact on the nervous system.

3. Cosmetics & Personal Care

  • Anti – Aging Skincare:
    • Added to night creams and serums (0.1 – 1% concentration) for its antioxidant and anti – inflammatory effects, protecting skin from nighttime oxidative stress and promoting cell repair.

4. Veterinary Medicine

  • Pet Sleep Supplements:
    • Used for pets with sleep disturbances, such as dogs and cats suffering from anxiety – related insomnia or adjusting to new environments.

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 for accurate quantification.
  • Liquid Chromatography – Mass Spectrometry (LC – MS):
    • Ideal for analyzing melatonin in biological samples (e.g., blood, urine), providing high sensitivity and specificity for detecting trace amounts.
  • UV – Visible Spectroscopy:
    • A quick – screening method for determining melatonin concentration in simple formulations, measuring absorbance at 220 nm.

Source & Advantages

  • Synthetic Production: Most commercial melatonin is synthetically produced through chemical synthesis, ensuring consistent quality and large – scale availability.
  • Cost – Effective Solution: Offers an affordable option for managing sleep disorders compared to prescription medications.
  • Global Acceptance: Widely recognized and regulated in major markets. For example, in the US, it is sold as a dietary supplement under DSHEA; in the EU, it is available as a traditional herbal medicinal product or OTC medicine depending on the formulation.
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Melatonin Supplementation: Science, Benefits & Premium Sourcing from Zhonghong

1. What is Melatonin?
Melatonin (N-acetyl-5-methoxytryptamine) is an endogenous indoleamine hormone primarily synthesized and secreted by the pineal gland in response to darkness. It serves as the body’s primary chronobiotic signal, regulating the sleep-wake cycle (circadian rhythm). Beyond its central role in sleep physiology, melatonin acts as a potent antioxidant and immunomodulator, influencing various physiological processes.

2. Source, Chemical Properties & Identifiers

  • Source: Naturally produced in humans, animals, plants, and microbes. Commercially, pharmaceutical-grade melatonin is predominantly synthesized via organic chemistry routes for purity and consistency. Shaanxi Zhonghong utilizes advanced synthesis and purification techniques.

  • Chemical Properties:

    • CAS Registry Number: 73-31-4

    • Molecular Formula (MF): C₁₃H₁₆N₂O₂

    • Molecular Weight (MW): 232.28 g/mol

    • EINECS: 200-797-7

  • Appearance: White to off-white crystalline powder.

  • Solubility: Sparingly soluble in water; soluble in ethanol, methanol, and DMSO.

  • Stability: Sensitive to light and oxidation; requires protective packaging (opaque, sealed).

3. Choosing the Best Melatonin: Efficacy, Dosage & Safety

  • “Best” Defined: The optimal melatonin supplement prioritizes:

    • Purity: ≥99.5% (HPLC), minimizing impurities and contaminants.

    • Consistency: Batch-to-batch reliability in dosage.

    • Verification: Rigorous third-party testing against pharmacopeial standards (USP, EP, JP).

    • Source & Manufacturing: cGMP-compliant facilities, like Zhonghong’s.

  • Highest Content? Melatonin content is standardized per dosage unit (e.g., 1mg, 3mg, 5mg, 10mg). “Most” isn’t always best; appropriate dosing is key. Zhonghong offers a range of high-purity powder concentrations.

  • Health Benefits & Efficacy:

    • Primary: Management of circadian rhythm sleep disorders (e.g., jet lag, shift work disorder, delayed sleep phase syndrome), reduction of sleep onset latency.

    • Secondary (Research Ongoing): Antioxidant support, potential immune modulation, possible role in migraine prophylaxis.

  • Recommended Daily Intake:

    • Start Low: 0.3mg to 1mg taken 30-60 minutes before desired bedtime is often sufficient for sleep initiation.

    • Therapeutic Range: Commonly 1mg to 5mg; higher doses (e.g., 10mg) are sometimes used under guidance but increase side effect risk. Consult a physician for personalized dosing.

  • Precautions:

    • Avoid operating machinery or driving after intake.

    • Contraindicated in autoimmune diseases, pregnancy, breastfeeding (unless advised by a doctor).

    • Caution with anticoagulants, immunosuppressants, diabetes medication, CNS depressants (alcohol, benzodiazepines).

    • Not a replacement for treating underlying sleep disorders (e.g., sleep apnea).

  • Potential Side Effects: Generally mild: daytime drowsiness, headache, dizziness, nausea. Higher doses increase risk of next-day grogginess, vivid dreams/nightmares, and potential hormonal effects.

4. Shaanxi Zhonghong Investment Technology Co., Ltd.: Your Premium Melatonin Source
Shaanxi Zhonghong Investment Technology Co., Ltd. is a vertically integrated high-tech enterprise specializing in advanced extraction, synthesis, purification, and application of bioactive compounds for chemistry, materials, and life sciences. With 28 years of industry expertise, we are a trusted global supplier.

  • Core Focus: Natural plant extracts, cosmetic actives, nutraceutical/API ingredients, natural pigments, and sweeteners – including premium synthetic Melatonin.

  • Scientific Prowess:

    • Research Barriers Overcome: Collaboration with 5 leading universities via joint laboratories.

    • IP Portfolio: 20+ patented technologies and a globally exclusive compound library.

  • Cutting-Edge Infrastructure:

    • Advanced Analytics: Equipped with High-Performance Liquid Chromatography (HPLC), Superconducting Nuclear Magnetic Resonance (NMR), GC-MS, ensuring unparalleled purity verification.

    • Purity Benchmark: Our Melatonin consistently exceeds typical industry purity standards by 20%+, guaranteeing superior quality and efficacy.

  • Global Reach: Extensive distribution network serving 80+ countries across Asia, Europe, and the Americas, providing bespoke ingredient solutions to multinational pharmaceutical corporations, research institutions, and supplement brands.

5. Health Benefits & Mechanism of Action

  • Circadian Rhythm Regulation: Melatonin binds to MT1 and MT2 receptors in the suprachiasmatic nucleus (SCN), signaling nighttime, promoting sleepiness, and synchronizing peripheral clocks.

  • Antioxidant Activity: Directly scavenges reactive oxygen species (ROS) and reactive nitrogen species (RNS); stimulates antioxidant enzymes (SOD, GPx); inhibits pro-oxidant enzymes.

  • Immune Modulation: Influences cytokine production and immune cell activity, potentially enhancing innate and adaptive immune responses within physiological contexts.

  • Sleep Onset: Reduces sleep latency by lowering core body temperature and promoting relaxation.

6. Melatonin Usage Guidelines

  • Timing: Take 30-60 minutes before bedtime. Crucial for circadian alignment.

  • Dosing: Start with the lowest effective dose (0.3-1mg). Increase gradually if needed, rarely exceeding 5-10mg without medical advice.

  • Consistency: Take at the same time nightly for circadian rhythm disorders.

  • Environment: Combine with good sleep hygiene: dark, quiet, cool room; avoid screens before bed.

7. Product Specifications: Rigorous Quality Control
Zhonghong’s Melatonin meets or exceeds major pharmacopeia standards (USP/EP). Our testing protocol includes:

Category Project Name Specification/Indicator Test Method
Pesticides Total Pesticides ≤ 1 ppm QuEChERS-GC/MS/MS
Specific Residues (e.g., DDT) ≤ 0.05 ppm EPA 8081B/GC-ECD
Heavy Metals Lead (Pb) ≤ 3 ppm USP <233> ICP-MS
Arsenic (As) ≤ 2 ppm USP <233> ICP-MS
Cadmium (Cd) ≤ 1 ppm USP <233> ICP-MS
Mercury (Hg) ≤ 0.1 ppm USP <233> CVAAS
Microbiology Total Aerobic Microbial Count ≤ 1000 CFU/g USP <61>
Total Yeast & Mold ≤ 100 CFU/g USP <61>
Escherichia coli Absent in 1g USP <62>
Salmonella spp. Absent in 10g USP <62>
Staphylococcus aureus Absent in 1g USP <62>
Pseudomonas aeruginosa Absent in 1g USP <62>
General Identification (HPLC/FTIR) Conforms USP <197>/EP 2.2.24
Assay (Purity) ≥ 99.5% USP Chromatographic Method
Loss on Drying ≤ 0.5% USP <731>
Residue on Ignition ≤ 0.1% USP <281>
Specific Rotation -35° to -45° USP <781>

8. Advanced Production Flow
Zhonghong’s process ensures supreme purity:

  1. High-Purity Synthesis: Controlled chemical synthesis using premium precursors.

  2. Initial Crystallization: Purification via solvent crystallization.

  3. Chromatographic Purification: Multi-stage HPLC purification for impurity removal.

  4. Recrystallization: Final crystallization for optimal crystal structure and purity.

  5. Rigorous Drying: Lyophilization or vacuum drying under controlled conditions.

  6. Micronization (Optional): Particle size reduction for enhanced bioavailability.

  7. Comprehensive QC Testing: Every batch undergoes full analytical suite (HPLC, GC-MS, ICP-MS, Microbiology) against stringent specs.

  8. cGMP Packaging: Protected in light-resistant, sealed containers under nitrogen atmosphere.

9. Diverse Application Scenarios

  • Dietary Supplements: Sleep aids, jet lag formulas, antioxidant blends.

  • Pharmaceuticals: Prescription sleep medications, adjunct therapies.

  • Functional Foods & Beverages: Sleep-supporting drinks, fortified foods (requires stable formulation).

  • Cosmeceuticals: Anti-aging creams/serums leveraging antioxidant properties.

  • Research: Biochemical studies, chronobiology research, animal model studies.

10. Stringent Quality Control (QC)
Zhonghong’s QC system is the cornerstone of our Melatonin’s reliability. Operating under strict cGMP principles, our state-of-the-art laboratory utilizes validated methods per USP, EP, and ICH guidelines. Identity is confirmed via HPLC retention time matching reference standards, FTIR spectroscopy, and specific rotation. Purity (Assay) is precisely quantified (>99.5%) using stability-indicating HPLC-UV/DAD methods, capable of resolving and quantifying even trace impurities. Residual Solvents are monitored by GC-HS according to USP <467>/ICH Q3C. Heavy Metals are analyzed using sensitive ICP-MS techniques (USP <233>) far below regulatory limits. Microbiological Safety is ensured through rigorous testing per USP <61>/<62> in our ISO-classified environment. Stability Studies (accelerated & long-term) under ICH Q1A(R2) conditions guarantee shelf life and storage recommendations. All data is managed via a secure, audit-ready LIMS. This multi-layered approach ensures every gram meets our uncompromising purity, potency, and safety standards for global markets.

11. Secure Packaging & Global Logistics

  • Primary Packaging: Double-sealed, food-grade polyethylene bags within robust, light-proof HDPE drums with desiccant. Nitrogen flushed for oxidation protection.

  • Secondary Packaging: Sealed cartons on pallets.

  • Storage: Store in a cool, dry place (15-25°C), protected from light and moisture.

  • Logistics: Efficient global shipping via air/sea freight. Comprehensive documentation (CoA, CoC, MSDS) provided. Strict adherence to international regulations (e.g., customs, IATA/IMDG if applicable).

12. Health Mechanisms, Innovation & Research Frontiers

  • Mechanism Deep Dive: Beyond SCN binding, melatonin activates nuclear receptors (RORα/RZR), modulates mitochondrial function, influences sirtuin pathways, and exhibits gene-regulatory effects relevant to aging and metabolism.

  • Industry Applications: Zhonghong focuses on enhancing bioavailability (liposomal, nanoemulsion delivery), developing sustained-release formulations melatonin gummies, and exploring highly pure (>99.9%) grades for research and sensitive applications.

  • Research Frontiers: Active areas include:

    • Melatonin’s role in neurodegenerative diseases (Alzheimer’s, Parkinson’s).

    • Impact on metabolic syndrome and glucose regulation.

    • Potential in oncology (adjuvant therapy, reducing side effects).

    • Gut-brain axis communication via melatonin.

    • Defining optimal dosing regimens for specific populations/conditions.

  • Challenges: Standardizing clinical trial methodologies, understanding long-term effects in diverse populations, optimizing delivery systems, and navigating complex global regulatory landscapes.

13. Frequently Asked Questions (FAQ)

  • Q: Is melatonin habit-forming? A: Melatonin is not considered addictive like traditional sleep medications. However, long-term reliance without addressing underlying causes of sleep issues is not ideal.

  • Q: Can I take melatonin with my prescription medication? A: Always consult your doctor or pharmacist. Potential interactions exist with blood thinners, immunosuppressants, diabetes meds, some antidepressants, and contraceptives.

  • Q: Why choose Zhonghong’s melatonin over others? A: We offer unparalleled purity (>99.5%), verified by advanced HPLC/NMR, stringent QC exceeding pharmacopeia standards, cGMP manufacturing, 28 years of bioactive expertise, and global regulatory support.

  • Q: What’s the shelf life? A: Typically 36 months when stored properly in original, unopened packaging under recommended conditions.

  • Q: Can children take melatonin? A: Only under the specific guidance and supervision of a pediatrician.

  • Q: Will melatonin make me groggy the next day? A: This is a common side effect, often linked to excessive melatonin dosage. Start with a very low dose (0.3-0.5mg).

  • Q: Does it help with anxiety? A: While improving sleep can reduce anxiety, melatonin is not a primary anxiolytic. Its direct anti-anxiety effects require more research.

14. Where to Buy Premium Melatonin
Interested in Zhonghong’s high-purity Melatonin for your supplement brand, research, or pharmaceutical application?

  • Contact: Mr. Liao Daohai

  • Email: liaodaohai@gmail.com

  • Website: www.aiherba.com

  • Inquire For: Current specifications (CoA), pricing (FOB/CIF), MOQs, private label options, and custom synthesis capabilities.

15. Conclusion
Melatonin is a vital, multi-functional hormone essential for regulating sleep and offering significant antioxidant benefits. Choosing a high-purity source like Shaanxi Zhonghong Investment Technology Co., Ltd. is paramount for ensuring safety, efficacy, and consistency. Leveraging 28 years of expertise, cutting-edge technology (HPLC, NMR), university collaborations, and a commitment to exceeding pharmacopeial standards (purity >99.5%), Zhonghong delivers premium melatonin backed by rigorous quality control from synthesis to shipment. Whether for dietary supplements, pharmaceuticals, or research, Zhonghong provides a scientifically validated, reliable global supply chain solution. Contact us today to discuss your melatonin requirements.

16. References

  1. 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.

  2. Reiter, R. J., et al. (2016). Melatonin as an antioxidant: under promises but over delivers. Journal of Pineal Research, 61(3), 253-278.

  3. Costello, R. B., et al. (2014). The effectiveness of melatonin for promoting healthy sleep: a rapid evidence assessment of the literature. Nutrition Journal, 13, 106.

  4. Tordjman, S., et al. (2017). Melatonin: Pharmacology, Functions and Therapeutic Benefits. Current Neuropharmacology, 15(3), 434–443.

  5. USP-NF Melatonin Monograph (Hypothetical Reference – Consult current USP/EP for official specs).

  6. ICH Harmonised Tripartite Guideline: Stability Testing of New Drug Substances and Products Q1A(R2).

  7. Shaanxi Zhonghong Investment Technology Co., Ltd. Company Documentation & Quality Control Protocols (Internal).

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