ISO 9001 · ISO 22000 · FAMI-QS · HACCP · Kosher · Halal · USDA / EU Orgánico
ISO 9001 · ISO 22000 · FAMI-QS · HACCP · Kosher · Halal · USDA / EU Orgánico

¿Qué es Melatonin? Aplicaciones, dosis, alternativas y especificaciones

Última actualización: 2026-11-14 · CAS 73-31-4 · grado alimenticio

Datos rápidos
Nombre
Melatonin
Número CAS
73-31-4
Grado
grado alimenticio
Certificaciones
ISO 9001 · ISO 22000 · HACCP · FAMI-QS · Kosher · Halal · GMP · SGS
Áreas de aplicación
2
Documentación
COA · TDS · SDS

Resumen

Melatonin, chemically known as N-Acetyl-5-methoxytryptamine, has the chemical formula C13H16N2O2, molecular weight 232.28, and CAS number 73–31–4. Melatonin es una 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 promueve secretion, inducing drowsiness. As humans age, the pineal gland calcifies and atrophies, plomoing to a significant decrease in melatonin production—from peak levels in childhood to lower levels in old age, which es un major reason for declining sleep quality in the elderly. Melatonin es unlso involved in various physiological processes incluyendo antioxidante defense, immune regulation, and endocrine regulation, making it a multifunctional endogenous hormone. Melatonin appears as a white to blanco roto cristalline polvo, odorless, con una 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 suplemento dietético and health supplement market. In China, melatonin is generally classified as a health supplement or suplemento dietético. 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 suplemento dietético, 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 proceso de producciónes. 1 Alto biocompatibility as an endogenous hormone Melatonin es una endogenous hormone naturally secreted by the human body, ofrecening outstanding advantages como 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 El núcleo 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 mejora sleep quality, shortens sleep latency, reducen the number of awakenings during sleep, and aumenta 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 es unlso used to alleviate jet lag caused by long-distance travel, help adjust the biological clock, and es adecuado para 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 antioxidante effects, scavenging free radicals, enhancing antioxidante enzima activity, previenening cellular oxidative damage, and slowing the aging process. Numerous clinical studies have indicated that melatonin possesses excellent antioxidante efficacy, with its main functions incluyendo 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, así como cytokine secretion. Melatonin also regulates the cardiovascular system, con unaumentand nighttime melatonin secretion being negatively correlated with decreased cardiovascular activity, helping to previenen arrhythmias caused by ischemia-reperfusion injury and regulating blood flow. Furthermore, melatonin regulates mood, protege nerve cells, and has anti-inflammatory and anti-apoptotic effects. 4 Bueno 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 (como those with circadian rhythm disruption debido a jet lag, shift work, or aging), it effectively mejora sleep quality. Compared to prescription sleeping pills, melatonin is non-addictive and has a good long-term safety record. 5 Continuously optimized proceso de producciónes Melatonin proceso de producciónes have evolved from early chemical synthesis to sintético biology fermentation, achieving a leap from traditional chemical synthesis to green bio-manufacturing. Based on sintético biology technology, microbiano cell factories produce natural product functional substances, solving problems associated with traditional botanical extractoion, como limited sources, control de calidad difficulties, complex components, and environmental pollution. Chinese enterprises have logrand the world‘s first large-scale bio-manufacturing of melatonin, filling domestic and international gaps con una cuota de mercado exceeding 70%, driving the industry into a green, eficiente, and sostenible development stage.

Aplicaciones

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Suplementos Dietéticos and Health Supplements

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

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Farmacéutico Preparations

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

Especificación

Pureza RequisitoMain CharacteristicsTípico Applications
Health Supplement Grado≥98.0%White to blanco roto cristalline polvo, compliant with health supplement ingredient catalog requirements
Melatonin tablets, softgels, oral líquidos, gummies
Grado farmacéutico≥98.5–99.5%Compliant with USP/EP/ChP standards, low impurities, low endotoxin
Farmacéutico preparations, extended-release tablets, clinical trial materias primas
Grado cosmético≥98.0%Alto pureza, low metales pesados
Anti-aging serums, eye creams, repair masks
Alto-Pureza/Research Grado≥99.5%Extremely alta pureza, compliant con unalytical standard requirements
Research reagents, reference standards, cell culture
3.3 Típico Technical Especificacións (Supplier Especificacións)ParámetroEspecificación Range
Método de ensayo
AparienciaWhite to blanco roto cristalline polvo, odorless, slightly bitter tasteInspección visual
Contenido (HPLC), %≥98.0–99.5 (depending on grade)Alto-performance líquido chromatography
Related Substances (Single Largest Impureza), %≤0.5–1.0HPLC
Related Substances (Total Impurities), %≤1.0–2.0HPLC
Humedad (Karl Fischer), %≤0.5Karl Fischer method/Direct drying method
Residue on Ignition, %≤0.1–0.2Alto-temperature cenizasing method
Metales pesados (como Pb), mg/kg≤10ICP-MS/Atomic absorption spectrometry
Plomo (Pb), mg/kg≤1.0ICP-MS/Atomic absorption spectrometry
Arsénico (As), mg/kg≤1.0ICP-MS/Atomic fluorescence spectrometry
Recuento total en placa, CFU/g≤1000Plate count method
Coliformes, MPN/g≤30Microbiological test method
Salmonela (25g)No detectadoMicrobiological test method
Staphylococcus aureusNo detectadoMicrobiological test method
Yeast and Mold, CFU/g≤100Microbiological test method
Bacterial Endotoxins (pharmaceutical grade), EU/mgAs specified de acuerdo con useLimulus amebocyte lysate method
Particle SizePersonalizado (20–200 mesh)Sieving method
Especificaciones de empaque1 kg/bolsa, 5 kg/bolsa, 10 kg/bolsa, 20 kg/bolsa, 25 kg/tambor, y otros specifications—
3.4 Empaque and Almacenamiento

Empaque y almacenamiento

  • Empaque: Tambor de fibra de 25 kg neto con doble forro de PE.
  • Muestra: Muestra gratis de 100-500 g disponible.
  • Almacenamiento: Mantener en envases bien cerrados, en lugar fresco, seco y bien ventilado. Proteger de la luz y la humedad.
  • Vida útil: 24 meses a partir de la fecha de fabricación.

Calidad y certificaciones

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

Cada lote es analizado por nuestro laboratorio de control de calidad interno. COA, TDS y SDS se proporcionan con cada envío.

Regulación y cumplimiento

UE

Cumple con las normativas de la UE y las normas FAMI-QS.

EE. UU.

Cumple con los requisitos de la FDA y la AAFCO.

China

Registrado bajo las normativas chinas del MOA.

Internacional

Certificado Kosher, Halal, ISO. Formularios TLC disponibles.

Seguridad y manipulación

  • Clase de peligro: Generalmente no peligroso. Consulte la SDS para más detalles.
  • Almacenamiento: Temperatura ambiente, seco, sellado. Evitar oxidantes fuertes.
  • Transporte: Mercancía no peligrosa. Flete marítimo/aéreo estándar.
  • SDS: Disponible bajo petición en sales@xadditive.cn.

Preguntas frecuentes

P1: ¿MOQ?

El MOQ es de 1 kg para prueba, 25 kg para pedidos regulares. Muestras gratis disponibles.

P2: ¿Vida útil?

24 meses a partir de la fecha de fabricación cuando se almacena correctamente.

P3: ¿Certificaciones?

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

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