High-Purity Melatonin Powder – 99.7% Pharmaceutical Grade Sleep Support Ingredient
Xi'an Jiayuan Bio-tech Co., Ltd. supplies pharmaceutical-grade Melatonin Powder with a verified assay of 99.7% (HPLC), manufactured under strict ISO9001 standards. The firm was founded in 2002 with a registered capital of RMB 30 million. We have 30 skilled R&D experts and two GMP-standard manufacturing lines. N-acetyl-5-methoxytryptamine (CAS No: 73-31-4) is a high purity crystalline form which satisfies USP43 requirements. Minimum order quantity: 1KG. In stock. Our product has uniform particle size and bioavailability and solves formulation problems in nutraceutical and pharmaceutical applications.
What Is Melatonin Powder?
The product is the concentrated crystalline, pharmaceutical grade version of the neurohormone naturally generated by the pineal gland to control circadian cycles. Unlike glandular extracts, our synthetic version removes biological impurities, but preserves the chemical identity (C13H16N2O2, MW: 232.28).
This white to off-white powder overcomes key production issues. Precise dose control for sleep aid formulations from 1mg to 10mg per unit. The consistent mesh size (80-100 mesh) provides homogenous blending in complicated matrices.
We manufacture at pharmaceutical grade purity levels over 99.5 % This enables the quick release and continuous release delivery systems . You may make sublingual pills or capsules, or beverage applications with predictable absorption patterns.
COA
| Product Name | Melatonin Powder | |||
| Lot No | 250409 | Quantity | 300kg | |
| Manufacture Date | 2024.04.24 | Expiry Date | 2026.04.23 | |
| Ref standard | USP43 | |||
| Items | Requirements | Results | ||
| Identification | INFRARED ABSORPTION | Conforms | ||
| ULTRAVIOLET ABSORPTION | ||||
| HPLC IDENTIFICATION TEST | ||||
| Loss on drying | ≤ 1_0% | 0.2% | ||
| Residue on ignition | ≤ 0.1% | 0.05% | ||
| Chlorides and Sulfates | ≤ 0.02% | Conforms | ||
| Heavy metal | As≤ 1ppm | Conforms | ||
| Cd≤ 1ppm | ||||
| Hg≤ 0.1ppm | ||||
| Pb≤ 1ppm | ||||
| Single impurity | ≤ 0.1% | 0.03% | ||
| Total impurities | ≤ 1.0% | 0.09% | ||
| Assay | 98.5% - 101.5% | 99.70% | ||
| Assay | 98.5% - 101.5% | 99.50% | ||
| Melting point | 116.0°C - 120.0°C | 116.4°C-119.2°C | ||
| Conclusion | This product conforms to requirements of USP43 | |||
Functions
The device tells the body’s internal clock, which governs the sleep-wake cycle, that it’s dark. Your pineal gland makes this hormone naturally at night—but supplementing fixes shortages created by shift work, jet lag, or ageing.
The hormone attaches to MT1 and MT2 receptors located in the suprachiasmatic nucleus. This interaction accelerates sleep phase time progress and lowers sleep onset latency. Clinical studies showed effectiveness within 30-120 minutes after ingestion.
In addition to sleep control, the chemical has significant antioxidant effects. It penetrates the blood brain barrier to neutralise free radicals in neural tissue. It is useful for neuroprotective formulations due to its dual activity.
Key physiological actions include:
- Circadian rhythm synchronization
- Sleep latency reduction (non-habit forming)
- Antioxidant protection at cellular level
- Support for seasonal affective patterns
Application Fields
Dietary Supplements Tablets, pills and gummies for sleep aid products for insomnia and circadian rhythm problems.
Pharmaceutical API: Active ingredient in prescription sleep medicines; transdermal patch formulations needing high purity inputs.
Functional Foods & Beverages: Sleep beverages, protein powders and nighttime snack bars with heat-stable melatonin incorporation.
Cosmetic Formulations: Melatonin’s antioxidant qualities are used in anti-aging serums and nite creams to restore the skin.
Veterinary Products. Sleep problem and anxiety supplements in companion animals.
Quality Control
Our quality assurance system covers four critical dimensions to ensure you receive consistent, contaminant-free material:
|
Test Parameter |
Specification |
Method |
|
Assay (Melatonin) |
≥99.7% |
HPLC (USP43) |
|
Appearance |
White to off-white powder |
Visual |
|
Particle Size |
80-100 mesh |
Sieve Analysis |
|
Heavy Metals (Pb, As, Hg, Cd) |
≤10 ppm total |
ICP-MS |
|
Residual Solvents |
Complies with ICH Q3C |
GC |
|
Microbial Limits |
E. coli, Salmonella: Negative |
MLT (USP) |
|
Total Plate Count |
≤1,000 cfu/g |
Plate Count |
|
Yeast & Mold |
≤100 cfu/g |
Plate Count |
Every batch undergoes TLC screening for related substances and impurities. We maintain lab facilities equipped with HPLC, GC, and ICP-MS instruments. This ensures your formulations meet international pharmacopoeia requirements.
Third-party testing through SGS and other accredited labs is available upon request. You receive Certificates of Analysis (CoA) with shipment documentation.
Certificates
- ISO9001 Quality Management System Certification (2012)
- HALAL Certification
- SGS Third-Party Verification
- Private Science and Technology Enterprise of Shaanxi Province
- High-tech Enterprise of Shaanxi Province
Payment & Shipment
Melatonin Powder may accept T/T, L/C, Western Union as payment options. The norm is 30% deposit and 70% payment before shipping for first-time purchasers.
We have a logistical network with Fedex, DHL, EMS, UPS and TNT for express shipping (3-7 days). For bigger purchases, you may choose for air freight (5-10 days) or sea freight (20-35 days).
For customers without import licenses, we provide customs clearance support in Europe and the United States. You receive door-to-door delivery with reduced administrative burden.
Free samples (10-20g) are available for quality evaluation before bulk ordering. We ship in-stock material within 48 hours of payment confirmation.
Packaging & Transportation
Standard Packing: 1KG/aluminum foil bag, 25KG/fiber drum lined with double food-grade PE bags.
We provide custom packaging solutions including nitrogen flushing for prolonged shelf life and private label services. All containers fulfil UN transit requirements for Class 4.1 materials.
Our inventory is stored in temperature controlled facilities (15-25°C, <60% RH). When correctly packed, this ensures chemical stability for storage up to 24 months.
Transportation documentation: MSDS, CoA, Commercial invoice and packing list. We adhere to IATA norms for air transport and IMDG guidelines for water transport.
After-sales Service
Our technical team provides formulation consultation for dosage optimization and excipient compatibility. You receive support throughout product development cycles.
If quality issues arise, we offer free replacement or full refund within 30 days of receipt. Our complaint response time averages 24 hours with resolution within 7 business days.
Regular customers benefit from inventory reservation services. We maintain strategic stock levels to prevent supply interruptions during peak seasons.
Annual quality review meetings help you stay updated on regulatory changes and formulation trends.
Exhibitions
We participate in major industry events including:
- Vitafoods Europe (Geneva)
- SupplySide West (Las Vegas)
- CPHI Worldwide (Rotating locations)
- Fi Asia (Bangkok)
Visit our booth to discuss custom specifications and view product samples. Our sales team arranges face-to-face consultations at these venues.
Why Choose Us?
Factory Direct Pricing: Factory direct pricing means no middleman mark-up. You save 15-30% compared to trading businesses.
Flexible MOQ: 1KG minimum order facilitates small-scale experiments before committing to big purchases. Multi-product orders lower per-shipment logistical expenses.
Stock Availability: Immediate shipment from our 500KG rotating inventory. No waiting for standard grades to be produced.
GMP Compliance: Two recognised manufacturing lines provide pharmaceutical-grade uniformity. Our facility undergoes yearly audits by international certifying authorities.
Customs Clearance Assistance: For purchasers in controlled markets, we arrange documents and liaise with local customs brokers. This cuts clearing time by 40%.
30 Person Technical Team: Formulation scientists support bioavailability increase, stability testing methodologies and regulatory dossier preparation.
FAQ
Q: How does synthetic melatonin compare to plant-derived melatonin?
A: Our synthetic version is of higher purity (99.7%) and does not carry the allergy hazards of natural extracts. The structure of molecules is similar to natural melatonin.
Q: How to store the product?
A: Store in tightly closed containers at a temperature between 15 and 25°C, protected from light and moisture. In these settings it will last for 24 months with no loss of performance.
Q: Can you offer paperwork for customs clearance?
A: Yeah. We provide CoA, MSDS, phytosanitary certifications and free sales certificates. FDA Prior Notice & REACH Compliance for shipping to EU/US
Q: How much time do you need on bespoke specs?
A: Stock products ship in 48 hours. Custom particle size or potency modifications take 10-15 days to produce and evaluate.
Q: Do you offer trial samples?
A: Free 10-20g samples are available for quality evaluation. Freight costs apply unless combined with future orders above 10KG.
Contact Us
Partner with Xi'an Jiayuan Bio-tech for reliable Melatonin Powder supply backed by 20+ years of manufacturing expertise. Request your free sample and CoA today at sales@jayuanbio.com and sales1@jayuanbio.com to start formulation trials.
