Description

Technical Parameters

Melatonin 10mg/bottle core introduction

Pharmaceutical-grade raw materials | Melatonin (N-acetyl-5-methoxytryptamine) made in China

Chemical name : N-acetyl-5-methoxytryptamine

CAS No .: 73-31-4

Specification : 10mg/bottle

Dosage form : Lyophilized powder for injection

Molecular formula : C₁₃H₁₆N₂O₂

Molecular weight : 232.28

Melting point : 116-118℃

Appearance : White crystalline powder

Purity : ≥99% (HPLC detection)

Storage conditions : Store at 2-8℃ away from light.

Core Function | Core Effects

Melatonin is an endogenous indoleamine hormone that is widely used in the treatment of sleep disorders, jet lag regulation, and neuroprotective research due to its circadian rhythm regulation and antioxidant properties .

✅Multiple physiological functions :

Circadian rhythm regulation : Regulates the biological clock and improves the sleep-wake cycle.

Antioxidant effect : A powerful free radical scavenger that protects cells from oxidative damage.

Immune regulation : Regulates immune function and enhances the body's resistance.

✅Quality advantages of Chinese manufacturing :

Optical purity : Chiral purity ≥ 99.8%, ensuring biological activity.

Crystal form control : Stable α-crystal form ensures solubility and stability.

Aseptic assurance : Aseptic production throughout the entire process, bacterial endotoxin <0.5 EU/mg

✅Global supply assurance :

Cold chain logistics : 2-8℃ cold chain transportation throughout the entire process to ensure product stability.

Multi-warehouse delivery : Regional warehouses are established in China, Europe, America, and the Asia-Pacific region, ensuring delivery within 7 days.

Customs clearance support : Complete export documents such as MSDS and COA

Production process and quality assurance

1. Advantages of the synthesis process :

Chemical synthesis : A green synthetic route was adopted, with an overall yield >85%.

Purification process : Column chromatography combined with recrystallization to obtain high-purity products.

Freeze-drying technology : temperature-controlled freeze-drying, moisture content ≤3.0%.

2. Strict quality control standards :

Chemical purity :

Main component content: 98.0%~102.0%

Related substances: Single impurity ≤0.1%, total impurities ≤0.5%

Residual solvent: Complies with ICH Q3C standards

Biological activity :

Receptor binding assay: MT1/MT2 receptor affinity meets the standard.

Antioxidant activity: DPPH free radical scavenging rate ≥90%

3. Stability data :

Long-term stability : Stored at 2-8℃ for 36 months, all indicators meet the requirements.

Accelerated testing : After being stored at 40℃ for 6 months, the purity decreased by ≤2.0%.

Stability in use : After reconstitution, store at 2-8℃ for 7 days; purity ≥95%.

Clinical application and scientific research value

1. Main application areas :

Sleep medicine : Insomnia, circadian rhythm disorder sleep disorders

Neuroprotection : Research on neurodegenerative diseases

Anti-aging research : Research on mechanisms related to delaying aging

2. Mechanism of action :

Receptor-mediated : Regulation of the sleep-wake cycle via MT1/MT2 receptors

Free radical scavenging : powerful antioxidant, protects mitochondrial function

Gene expression : Regulation of circadian rhythm-related gene expression

3. Clinical advantages :

High safety profile : physiological hormones, mild side effects.

Rapid onset of action : Peak blood drug levels are reached 30 minutes after injection.

Short half-life : approximately 20-50 minutes, facilitating dosage adjustment.

Global supply and service assurance

1. Production capacity :

Annual production capacity : Over 100 kg per year

Flexible manufacturing : Customized specifications and packaging requirements are acceptable.

Production capacity assurance : Multiple production lines ensure stable supply

2. Quality Certification :

System Certification : Certified by ISO 9001 Quality Management System

Compliant with pharmacopoeia : Meets the standards of the Chinese Pharmacopoeia, USP, and EP.

Complete documentation : Provides a complete package of quality documentation.

3. Logistics support :

Temperature-controlled packaging : uses phase change materials, with a heat preservation time of ≥72 hours at 2-8℃.

Real-time monitoring : Equipped with a temperature recorder, temperature data can be traced throughout the entire process.

Emergency Plan : Establish an emergency response mechanism for abnormal situations.

Why choose Chinese-made melatonin?

Exceptional purity : Over 99% high purity, with strict impurity control.

Advanced technology : Green synthesis route, environmentally friendly and efficient

Stable quality : A strict quality control system ensures minimal batch-to-batch variation.

Reliable supply : Large-scale production capacity, timely delivery

Summarize

in China, 10mg lyophilized melatonin powder for injection represents the high-quality standard of endogenous hormone preparations . Through advanced synthesis processes, rigorous quality control, and a stable supply system , it provides high-quality, highly active products for global sleep medicine and neuroscience research . Choosing Made in China means choosing professional quality and reliable assurance .

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