1. Market Overview & Industry Trends
The Melatonin 99% Powder Pharmaceutical Intermediate China Manufacturer Sleeping-Aid has rapidly become a cornerstone in the sleep-aid and pharmaceutical intermediates segment worldwide. In 2023, global melatonin market size exceeded 1.85 billion USD, with China's output accounting for over 60% of total volume (Source: GrandViewResearch). Leading Chinese producers have solidified technical process reliability, acquisitive purity levels (“99%+”), and scalable custom formulation possibilities to meet diverse client needs, especially for American and European brands.
- Purity Upgrades: Over 95% of global pharmaceutical-grade melatonin supply is now achieving purity above 99% (per FDA/CP2020/ISO9001 standards).
- Traceability & Safety: Advanced QA/QC leverages HPLC, GC-MS, and LC-MS/MS to guarantee traceability, with impurity profile measurements down to
- Formulation Evolution: Demand in functional food/beverage and sustained-release supplement brands is driving enzymatic/intermediate customization.
- Green Chemistry: Top Chinese manufacturers increasingly adopt greener solvents and recovery practices, with CO₂ emission reduction targets ±10%/year.
- Global Compliance: Stringent adherence to ISO 9001, FDA GRAS, and CP2020 guarantees cross-border deliverability and market authoritativeness.
2. Technical Parameters & Product Specifications
Melatonin 99% Powder Pharmaceutical Intermediate China Manufacturer Sleeping-Aid is distinguished by its ultra-high purity, robust production controls, and pharmaceutical-grade performance. Below, key technical parameters are consolidated into a visual data table for buyer reference:
| Parameter | Typical Value | Test Method | Standard |
|---|---|---|---|
| Appearance | White or Off-white, crystalline powder | Visual, Microscopy | CP2020, USP43 |
| Purity (Melatonin Content) | ≥99.0% | HPLC | ISO9001, FDA |
| Specific Rotation | +58° ~ +62° | Polarimeter | Ph. Eur |
| Loss on Drying | ≤0.5% | Gravimetric | CP2020 |
| Residue on Ignition | ≤0.1% | Gravimetric | USP43 |
| Heavy Metals | ≤10 ppm | ICP-MS | CP2020, USP |
| Microbial Limit | TAMC < 1000 CFU/g; TYMC <100 CFU/g | Plate Count | ISO11737 |
| Assay | ≥99.0% | HPLC | CP, USP, FCC |
The advanced manufacturing flow of Melatonin 99% Powder Pharmaceutical Intermediate China Manufacturer Sleeping-Aid embodies Green Chemistry, ensuring maximum purity, low impurities and repeatable quality.
Pharmaceutical-grade tryptophan & other organic substrates, fully traceable (supplier GMP audit)
Enzymatic/chemical condensation (including acetylation & methylation), with process temp. 0~40°C
Solvent extraction, multi-stage crystallization for impurity removal (measured by HPLC, GC-MS)
Membrane/activated carbon filtration, vacuum drying at ≤50°C
Full-spectrum QA: HPLC, FTIR, water activity, heavy metal & residual solvent analysis; ISO/FDA certified packaging lines
Testing: Each batch is traceable, with retain samples for 3 years (per ISO 22000, FDA and local GMP).
4. Data Visualization: Technical Parameters & Market Trends
Data sources: GrandViewResearch, Statista, China Chamber of Commerce, Corporate Docs (2024 update)
5. Application Scenarios & Typical Cases
Melatonin 99% Powder Pharmaceutical Intermediate China Manufacturer Sleeping-Aid is ideal for high-purity health supplement manufacturing, new drug R&D, sleep-regulating food & beverage functionalization, and as custom API/intermediate for pharmaceutical export orders.
Application: Direct compression into extended-release tablets.
Result: Leveraging 99.6% purity reduces tablet bulk by 12% while maintaining sleep efficacy per FDA OTC Monograph M002; 2.6× stability enhancement under 40°C/75%RH (accelerated test).
Application: Melatonin as intermediate for psycho-neuro drug synthesis.
Result: Custom microcrystalline type reduced downstream reaction impurities by 18% per batch, boosting API yield. All process meets CP2020 and Melatonin 99% Powder Pharmaceutical Intermediate China Manufacturer Sleeping-Aid specifications.
Application: Emulsified water-soluble premix.
Result: Customized synergies achieved, meeting GRAS & FSSC22000 compliance, with zero detectable residual solvents in third-party testing.
6. Manufacturer Comparison Table
| Manufacturer | Country | Typical Purity (%) | Main Certifications | Custom Options | Production Capacity (MT/Y) |
|---|---|---|---|---|---|
| Finutra Biotech [Official Link] |
China | 99~99.7 | ISO9001, FSC, FDA, GRAS | Particle Size, Formulation, Package | 36 |
| Gnosis by Lesaffre | Italy | 98.5~99.3 | GMP, ISO22000 | Premix, Organic Cert. | 8 |
| NutraScience Labs | USA | 98~99.1 | NSF, FDA | Custom Blend, Bottling | 5 |
| Other Chinese OEMs | China | 97.5~99 | ISO, FDA | Bulk, OEM Packing | 18 |
Melatonin 99% Powder Pharmaceutical Intermediate China Manufacturer Sleeping-Aid can be tailored for downstream use-cases:
- Particle Size Control: D50 from 5μm–150μm (for direct compression, granulation, water solubility)
- Custom Packaging: From 500g foil bags to 25kg fiber drums, inert-gas flushed, ISO22000/FSSC22000 handling.
- Stability/Test Protocols: Third-party stability data under ICH conditions available on request.
- Residue/Impurity Controls: Controlled below FDA/CP2020 threshold; MSDS and COA for each lot.
- Microencapsulation: Enables food-grade prolonged-release powder or beadlets.
8. Technical Advantages
- Ultra-High Purity (≥99.6%) – Constantly ranks among global top-two by pharma QC agencies.
- Flexible Customization – Granularity, compounding, and solubility can be tuned for direct tablet, capsule, or beverage production.
- Stringent Certification – Products conform to ISO22000, FDA, USP, and FSSC22000 protocols.
- Long Shelf Life – Anchored by ≥2 years in sealed conditions, validated through ICH stability trials (40°C, 75% RH).
- Sustainability Practices – Recycling solvents, energy efficiency protocols, and raw material traceability audited annually.
- Warranty: Each lot backed by COA/MSDS, 2-year shelf-life, with customer refund/replacement guarantee if out-of-specification.
- Delivery: 5–15 days ex-factory, DDU/FOB/CIF available for global clients.
- Technical/Regulatory Support: 24-hour expert support: regulatory docs, customs clearing, and custom formulation consulting.
- Sample Policy: Free 50g R&D sample for qualified pharma/health food clients upon request.
For more information or a tailored quotation, visit the Melatonin 99% Powder Pharmaceutical Intermediate China Manufacturer Sleeping-Aid product page.
10. References & Authoritativeness
- Grandview Research, Melatonin Market Size, Share & Trends Analysis Report By Application, Region, And Segment Forecasts, 2024. [link]
- Nutrition Business Journal, "2024 Ingredient Trends: Melatonin & Innovation", Issue 03/2024. [link]
- FDA GRAS Notification for Melatonin, U.S. FDA. [link]
- Peer-reviewed: "Melatonin as a Sleeping Aid: Clinical Validation and Industrial Synthesis", European Journal of Pharmaceutical Sciences, Vol. 184 (2023). [link]
- ChinaPharmaForum, "Melatonin API: Value Chain, Export, Regulatory Update", Forum Digest 2023. [link]
Post time:Jul - 30 - 2025
