2.Specification:99%
3.Cas:73-31-4
4.Free Sample
5.Capsules,tablets,softgel,gummies,small bags,private label
6.Test Method:HPLC
7.Vacuum Aluminum Foil Bag; Fiber Drum for 25kg with inside double layer food grade poly bag
8.DeliveryTime:1-3 working days
Organic,Gluten free,no Allergen,Non-GMO,Paraben free,No Colors, BSE/TESE Free,Vegan
- Product Description
Melatonin Powder: Premium-Grade Sleep Support Ingredient
Discover pharmaceutical-grade Melatonin Powder (99% purity, CAS 73-31-4) designed specifically for advanced sleep-aid formulations. Produced in a GMP-certified and ISO-compliant facility, every batch is carefully monitored to guarantee exceptional consistency, safety, and reliability. Our product is suitable for creating a wide range of products, including capsules, tablets, gummies, and innovative custom blends tailored to meet unique market needs. With dedicated 24/7 technical support and strict quality assurance, we provide trusted solutions that meet global standards and are relied upon by leading international brands.
Why Choose Our Melatonin Powder?
- Certified Excellence: Produced in a GMP, ISO 22000, and FSSC 22000-certified facility with Halal/Kosher/USDA Organic options.
- Precision Purity: HPLC-tested for ≥99% purity, heavy metals <10ppm, and microbial safety (Salmonella-free).
- End-to-End Support: Custom blends, regulatory documentation (DMF, CofA), and cold-chain logistics.
Certificate of Analysis (COA)
Items |
Specifications |
Results |
Test method |
Appearance |
Off-white powder |
Passed |
By visual inspection |
Identification–IR |
Passes Test |
Passes Test |
USP 43 |
Identification–UV |
Passes Test |
Passes Test |
USP 43 |
Identification–HPLC |
Passes Test |
Passes Test |
USP 43 |
Odor |
Characteristics |
Passed |
By organoleptic inspection |
Assay (HPLC) |
98.5%-101.5% |
99.5% |
USP 43 |
Individual impurity |
≤ 0.1% |
0.07% |
USP 43 |
Total impurity |
≤ 1.0% |
0.25% |
USP 43 |
Loss on drying |
≤ 1.0% |
0.08% |
USP<731> |
Residue on ignition |
≤ 0.1% |
0.06% |
USP<281> |
Chloride |
≤ 0.02% |
<0.02% |
USP<221> |
Residual solvent |
Meets as per USP |
Passed |
USP<467> |
Particle Size |
Thru 80 mesh NL95% |
Passed |
GB/T 19077-2016/ ISO 13320:2009 |
Heavy Metals |
≤ 10 ppm |
<10 ppm |
USP<231> |
Lead |
≤ 0.5 ppm |
<0.5 ppm |
USP<251> |
Arsenic |
≤ 1.0 ppm |
<1.0 ppm |
USP<211> |
Cadmium |
≤ 0.3ppm |
<0.3 ppm |
USP<851> |
Mercury |
≤ 0.2 ppm |
<0.2 ppm |
USP<261> |
Chromium |
≤ 2.0 ppm |
<2.0 ppm |
USP 43 |
Total Aerobic Count |
≤ 1,000 cfu/g |
<1,000 cfu/g |
USP<61> |
Molds and Yeasts |
≤ 50 cfu/g |
<50 cfu/g |
USP<61> |
Coliforms |
NMT100 cfu/g |
NMT100 cfu/g |
USP<61> |
E.Coli |
Negative to test |
Negative to test |
USP<61> |
Staphylococcus Aureus |
Negative to test |
Negative to test |
USP<61> |
Salmonella |
Negative to test |
Negative to test |
USP<61> |
Storage Shelf Life |
Store in a well-closed containers,in a cool dry area. Two years if sealed and stored away from direct sun light and heat. |
||
Conclusion |
The product complies with enterprise standard. |
*Please contact us for the latest COA.
Key Benefits of Melatonin Powder
- Sleep Cycle Regulation: Supports treatment of insomnia and jet lag.
- Antioxidant Properties: Enhances formula stability in tablets/gummies.
- Global Compliance: Ready for FDA, EMA, and TGA submissions.
How We Ensure Quality?
1. Raw Material Screening: Sourced from trusted suppliers with purity audits.
2. Continuous Countercurrent Extraction: Maximizes yield (99% efficiency).
3. Ultrafiltration & Spray-Drying: Removes impurities while preserving potency.
4. Third-Party Validation: Batch-specific COAs and 24-month stability reports.
Applications in Sleep-Aid Products
Use our melatonin powder in:
- Tablets/Capsules: Fast-dissolving formulations.
- Gummies/Softgels: Heat-stable blends for taste-sensitive formats.
- Functional Foods/Beverages: Sleep-supporting teas or protein bars.
Certifications
ISO 9001, FSSC 22000, Halal, Kosher, cGMP, and USDA Organic.
Custom Solutions & Packaging
- OEM/ODM Services: Adjust dosage (0.5–10mg), add excipients (e.g., magnesium glycinate), or create private-label gummies.
- Packaging: Moisture-proof aluminum bags or fiber drums with climate-controlled shipping.
Frequently Asked Questions
Q: What's the MOQ?
A: 1kg (flexible for long-term partners).
Q: Can you supply FDA-compliant documentation?
A: Yes, including DMFs and product-specific CofAs.
Q: Do you offer organic product?
A: Yes, USDA/EU Organic-certified options available.
Q: How is degradation prevented during shipping?
A: Vacuum-sealed packaging and temperature-controlled logistics.
Ready to Order?
📩 Email sales@fairirbiotech.com for:
- Free samples
- Bulk pricing
- Regulatory support
Boost your sleep-aid line with globally compliant Melatonin Powder – trusted by pharmaceutical leaders.