O que é Melatonin? Aplicações, dosagem, alternativas e especificações

Última atualização: 2026-11-14 · CAS 73-31-4 · grau alimentício

Dados rápidos
Nome
Melatonin
Número CAS
73-31-4
Grau
grau alimentício
Certificações
ISO 9001 · ISO 22000 · HACCP · FAMI-QS · Kosher · Halal · GMP · SGS
Áreas de aplicação
2
Documentação
COA · TDS · SDS

Resumo

Melatonin, chemically known as N-Acetyl-5-methoxytryptamine, has the chemical formula C13H16N2O2, molecular weight 232.28, and CAS number 73–31–4. Melatonin is an amine hormone secreted by the pineal gland in mammals, belonging to the tryptophan derivative family, and plays a central role in regulating circadian rhythms and the sleep-wake cycle. The secretion of melatonin follows a distinct circadian rhythm: during the day, light inhibits secretion, keeping the person awake; at night, darkness promotes secretion, inducing drowsiness. As humans age, the pineal gland calcifies and atrophies, leading to a significant decrease in melatonin production—from peak levels in childhood to lower levels in old age, which is a major reason for declining sleep quality in the elderly. Melatonin is also involved in various physiological processes including antioxidant defense, immune regulation, and endocrine regulation, making it a multifunctional endogenous hormone. Melatonin appears as a white to off-white crystalline powder, odorless, with a slightly bitter taste. Within the recommended dosage range, melatonin has a good safety profile. Due to its significant efficacy in improving sleep quality, regulating circadian rhythms, and alleviating jet lag, melatonin has become one of the fastest-growing star products in the global dietary supplement and health supplement market. In China, melatonin is generally classified as a health supplement or dietary supplement. According to China‘s health supplement ingredient catalog, the daily dosage of melatonin is 1–3 mg.

Melatonin is known as the “hormone of life” and the “core molecule of sleep regulation,” occupying a rapidly rising core position in the global dietary supplement, health supplement, and pharmaceutical fields. Its most prominent core advantages include: high biocompatibility as an endogenous hormone, superior sleep regulation efficacy, broad physiological regulatory functions, good safety profile, and continuously optimized production processes. 1 High biocompatibility as an endogenous hormone Melatonin is an endogenous hormone naturally secreted by the human body, offering outstanding advantages such as natural, gentle action, and high safety. Compared to chemically synthesized sleep aids, melatonin has no drug dependence or withdrawal symptoms (within the recommended dosage range), does not cause next-day drowsiness or other side effects, and has no toxic effects on the human nervous system or organs. Since it originates from the human body itself, exogenous melatonin supplementation can mimic natural sleep rhythms, helping users establish healthy sleep patterns rather than inducing forceful sleep. 2 Superior sleep regulation efficacy The core application value of melatonin lies in its function of regulating sleep and circadian rhythms. Melatonin activates melatonin receptors MT1 and MT2 in the brain, shortening sleep latency and prolonging deep sleep duration, especially suitable for individuals with short-term insomnia caused by stress, schedule disruption, or aging. Clinical studies have shown that taking 1 mg of melatonin 2 hours before bedtime effectively improves sleep quality, shortens sleep latency, reduces the number of awakenings during sleep, and increases sleep efficiency and quality. Additionally, melatonin is particularly effective in treating circadian rhythm sleep disorders in patients with dementia, especially those with sundowning syndrome. Melatonin is also used to alleviate jet lag caused by long-distance travel, help adjust the biological clock, and is suitable for shift workers, night shift workers, and those needing to adapt to new sleep schedules. 3 Broad physiological regulatory functions Melatonin is not only a sleep-regulating hormone but also participates in various physiological processes. Melatonin has powerful antioxidant effects, scavenging free radicals, enhancing antioxidant enzyme activity, preventing cellular oxidative damage, and slowing the aging process. Numerous clinical studies have indicated that melatonin possesses excellent antioxidant efficacy, with its main functions including promoting collagen synthesis, boosting the immune system, and reducing oxidative stress. Melatonin has a bidirectional regulatory effect on the immune system, affecting the growth and development of immune organs, regulating humoral and cellular immunity, as well as cytokine secretion. Melatonin also regulates the cardiovascular system, with increased nighttime melatonin secretion being negatively correlated with decreased cardiovascular activity, helping to prevent arrhythmias caused by ischemia-reperfusion injury and regulating blood flow. Furthermore, melatonin regulates mood, protects nerve cells, and has anti-inflammatory and anti-apoptotic effects. 4 Good safety profile Within the recommended dosage range, melatonin has a good safety profile. According to China‘s health supplement ingredient catalog, the daily dosage of melatonin is 1–3 mg. When used appropriately for specific populations (such as those with circadian rhythm disruption due to jet lag, shift work, or aging), it effectively improves sleep quality. Compared to prescription sleeping pills, melatonin is non-addictive and has a good long-term safety record. 5 Continuously optimized production processes Melatonin production processes have evolved from early chemical synthesis to synthetic biology fermentation, achieving a leap from traditional chemical synthesis to green bio-manufacturing. Based on synthetic biology technology, microbial cell factories produce natural product functional substances, solving problems associated with traditional botanical extraction, such as limited sources, quality control difficulties, complex components, and environmental pollution. Chinese enterprises have achieved the world‘s first large-scale bio-manufacturing of melatonin, filling domestic and international gaps with a market share exceeding 70%, driving the industry into a green, efficient, and sustainable development stage.

Aplicações

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Suplementos Dietéticos e Suplementos de Saúde

Dietary supplements and health supplements are the most widely used and largest market for melatonin. 1 Sleep Improvement/Insomnia Products: The core…

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Preparações Farmacêuticas

The application of melatonin in the pharmaceutical field is continuously deepening. 1 Extended-Release Melatonin Preparations (Drugs): In Europe…

Especificação

Purity RequirementMain CharacteristicsTypical Applications
Health Supplement Grade≥98.0%White to off-white crystalline powder, compliant with health supplement ingredient catalog requirements
Melatonin tablets, softgels, oral liquids, gummies
Pharmaceutical Grade≥98.5–99.5%Compliant with USP/EP/ChP standards, low impurities, low endotoxin
Pharmaceutical preparations, extended-release tablets, clinical trial raw materials
Cosmetic Grade≥98.0%High purity, low heavy metals
Anti-aging serums, eye creams, repair masks
High-Purity/Research Grade≥99.5%Extremely high purity, compliant with analytical standard requirements
Research reagents, reference standards, cell culture
3.3 Typical Technical Specifications (Supplier Specifications)ParameterSpecification Range
Test Method
AparênciaWhite to off-white crystalline powder, odorless, slightly bitter tasteVisual inspection
Content (HPLC), %≥98.0–99.5 (depending on grade)High-performance liquid chromatography
Related Substances (Single Largest Impurity), %≤0.5–1.0HPLC
Related Substances (Total Impurities), %≤1.0–2.0HPLC
Moisture (Karl Fischer), %≤0.5Karl Fischer method/Direct drying method
Residue on Ignition, %≤0.1–0.2High-temperature ashing method
Heavy Metals (as Pb), mg/kg≤10ICP-MS/Atomic absorption spectrometry
Lead (Pb), mg/kg≤1.0ICP-MS/Atomic absorption spectrometry
Arsenic (As), mg/kg≤1.0ICP-MS/Atomic fluorescence spectrometry
Total Plate Count, CFU/g≤1000Plate count method
Coliforms, MPN/g≤30Microbiological test method
Salmonella (25g)Not detectedMicrobiological test method
Staphylococcus aureusNot detectedMicrobiological test method
Yeast and Mold, CFU/g≤100Microbiological test method
Bacterial Endotoxins (pharmaceutical grade), EU/mgAs specified according to useLimulus amebocyte lysate method
Particle SizeCustom (20–200 mesh)Sieving method
Packaging Specifications1 kg/bag, 5 kg/bag, 10 kg/bag, 20 kg/bag, 25 kg/drum, and other specifications—
3.4 Packaging and Storage

Embalagem e armazenamento

  • Embalagem: 25kg net fiber drum with double PE liner.
  • Amostra: 100-500g free sample available.
  • Armazenamento: Keep in tightly closed packaging, cool, dry, well-ventilated. Protect from light and moisture.
  • Validade: 24 months from production date.

Qualidade e certificações

ISO 9001 ISO 22000 HACCP FAMI-QS Kosher Halal GMP SGS

Cada lote é testado pelo laboratório de QC interno. COA, TDS e SDS fornecidos com cada remessa.

Regulamentação e conformidade

UE

Em conformidade com os regulamentos da UE e padrões FAMI-QS.

EUA

Aos requisitos da FDA e AAFCO.

China

Registrado conforme os regulamentos chineses do MOA.

Internacional

Certificado Kosher, Halal e ISO. Formulários FTA disponíveis.

Segurança e manuseio

  • Classe de Perigo: Geralmente não perigoso. Consulte a SDS para detalhes.
  • Armazenamento: Temperatura ambiente, seco, fechado. Evitar oxidantes fortes.
  • Transporte: Mercadoria não perigosa. Frete marítimo/aéreo padrão.
  • SDS: Disponível mediante solicitação em sales@xadditive.cn.

Perguntas frequentes

P1: MOQ?

O MOQ é de 1 kg para teste e 25 kg para pedidos regulares. Amostras grátis disponíveis.

P2: Validade?

24 meses a partir da data de fabricação quando armazenado corretamente.

P3: Certificações?

ISO 9001, ISO 22000, HACCP, FAMI-QS, Kosher, Halal, COA, SDS, TDS.

P4: Como obter uma cotação?

Envie um e-mail para sales@xadditive.cn com sua exigência. Respondemos em até 30 minutos.

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Solicite a ficha técnica atual, uma amostra de COA e uma cotação por volume — resposta em 30 minutos em dias úteis.

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