Product Overview
Ectoin is a natural, amino acid-derived extremolyte used to support cellular structures and biomolecules under environmental stress conditions.
Technical Specifications
|
Section |
Parameter |
Specification / Target |
|
Physical & Chemical Properties |
Appearance |
White to off-white powder |
|
Identification (IR) |
Conforms to standard |
|
|
Assay / Purity (HPLC) |
≥ 99.0% |
|
|
PH (2% aqueous solution) |
6.0 – 8.0 |
|
|
Melting Point |
280 °C |
|
|
Loss on Drying (LOD) |
≤ 0.5% |
|
|
Residue on Ignition |
≤ 0.1% |
|
|
Water Solubility (20°C) |
> 700 g/L |
|
|
Heavy Metals & Impurities |
Total Heavy Metals (as Pb) |
< 5 ppm |
|
Arsenic (As) |
< 1 ppm |
|
|
Microbiological Quality |
Total Aerobic Count |
< 10 CFU/g |
|
Yeast & Mold |
< 10 CFU/g |
|
|
Escherichia coli |
Absent |
|
|
Staphylococcus aureus |
Absent |
|
|
Pseudomonas aeruginosa |
Absent |
|
|
Application & Stability |
Recommended Usage |
0.5% – 2.0% |
|
Thermal Stability |
Up to 80°C |
|
|
PH Stability Range |
4.0 – 8.0 |
|
|
Light Stability |
No degradation under UV/visible exposure |
Manufacturing & Quality Control
Process & Equipment
• Bio-fermentation Process: High-density bacterial cultivation is carried out in automated bioreactors under controlled parameters to ensure stable batch output.
• Purification Technology: Multi-stage filtration and crystallization systems are used to separate the compound from the fermentation broth.
• Facility Standards: Production lines are operated in GMP-compliant cleanrooms with continuous environmental monitoring.
Quality Control Flow
• Raw Material Screening: Incoming raw materials undergo chemical verification before entering production.
• In-Process Monitoring: Fermentation parameters are monitored during production to keep batches within specification ranges.
• Analytical Verification: Finished batches are tested by HPLC for purity and GC for residual solvents.
Compliance & Certifications
|
Certification / Standard |
Regulatory Scope & Compliance Status |
|
ISO 22716 / GMPC |
Manufacturing facility operates under cosmetic GMP guidelines |
|
EFfCI GMP |
Production follows European cosmetic ingredient GMP requirements |
|
COSMOS / ECOCERT |
Raw materials meet criteria for natural / organic cosmetic use |
|
Halal & Kosher |
Processing and materials comply with dietary certification requirements |
|
REACH Registration |
Substance compliance documentation available for EU market import |
|
INCI Registered |
Ingredient name officially listed in international cosmetic ingredient system |
Supply Chain & Capacity
|
Parameter |
Specifications |
|
Annual Capacity |
50 Metric Tons |
|
Production Setup |
Dual-line fermentation |
|
Packaging |
1 kg foil bags / 25 kg fiber drums |
|
Storage |
Temperature & humidity controlled |
|
Logistics |
Sea freight |
|
Lead Time |
7–14 days |
|
Urgent Orders |
Prioritized allocation |
FAQ
Q: Does the production process involve any genetically modified organisms (GMOs)?
A: No, the fermentation process uses a wild-type bacterial strain without genetic modification.
Q: How is the risk of residual bacterial endotoxins managed in production?
A: Multi-stage purification includes charcoal adsorption and ultrafiltration to reduce residual endotoxins.
Q: What documents are provided for customs clearance during importation?
A: Shipments include COA, SDS, and technical data sheets.
Q: Does the ingredient contain any common allergens or animal-derived components?
A: The material is produced via microbial fermentation, vegan, and free from major allergens.
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