Maintain 100% production uptime with Exbiol® global inventory. 5,000kg ready-to-ship. Global lead time: 3-5 days. Standardized packaging for seamless industrial integration.
Validate your anti-stress formula with verified HPLC Fingerprinting. 100% molecular stability across pH 1–13. Zero residual synthesis catalysts.
As the life-science division of Zhonghong Group, Exbiol® provides premium Ectoin bulk supply. Our extremolyte isolate resolves the industrial challenge of ingredient degradation under pH and thermal stress, ensuring 100% molecular integrity for Tier-1 dermaceutical and ophthalmic formulations.
96702-03-3
≥ 99.0%
White Crystal
+139° to +145°
Aqueous Clarity
GMP / COSMOS
1. What is Ectoin?
Ectoin is a natural extremist amino acid derivative produced by halophilic bacteria. As a highly compatible solute, it serves as an “extremolyte,” protecting biological membranes and DNA from UV radiation, high salinity, and thermal fluctuations. In industrial skincare, Ectoin is prized for its functional property of forming the “Ectoin-Hydro-Complex,” a stable hydration shell that fortifies the skin barrier at a molecular level.
2. Technical Specifications Table
| Parameter | Industrial Specification |
|---|---|
| Assay (on dry basis) | ≥ 99.0% (HPLC) |
| Specific Rotation | +139.0° to +145.0° |
| Loss on Drying | ≤ 1.0% |
3. Source & Origin
Exbiol® Ectoin is produced via precision halophilic fermentation using non-GMO strains of Halomonas elongate. Our industrial process utilizes osmotic stress induction (“Bacterial Milking”) to trigger the intracellular accumulation and release of pure Ectoin. This biological route ensures 100% molecular authenticity and zero protein impurities compared to synthetic analogues.
4. Mechanism of Action
The primary mechanism involves the organization of water molecules into a stable, dense shell. This Ectoin-Hydro-Complex provides a functional property of stabilizing lipid bilayers and preventing the denaturation of proteins under environmental stress. For R&D, it is valued for its ability to modulate ICAM-1 expression and support functional DNA repair mechanisms post-UV exposure.
Thermal Stress Engineering
Industrial advantage: Ectoin maintains 100% integrity up to 80°C and across pH 1.0–13.0. Formulators can add Ectoin during the heating phase of emulsions without loss of potency, a critical advantage for large-scale industrial processing.
Ionic Compatibility
Ectoin is a non-ionic zwitterion. It exhibits exceptional industrial compatibility with high-electrolyte systems and carbomer thickeners, ensuring no viscosity drop in complex serum formulations.
5. Application Benefits
- Global Anti-Pollution: Functional property for reducing particle-matter induced skin stress.
- Barrier Restoration: May support the functional property of epidermal barrier integrity.
- Bio-Stability: Formulation advantage: Resistant to browning and enzymatic degradation.
6. Usage & Formulation Guide
Dissolution Habit: Instant Aqueous Clarity. Soluble in water up to 50% w/w. Processing: Add directly to the aqueous phase. pH Range: Highly stable from pH 3.0 to 9.0 (optimal). Compatible with AHAs and Vitamin C.
7. Industrial Evolution
From crude microbial extracts to Exbiol’s Third-Generation Bio-fermentation Isolate. We utilize advanced ion-exchange chromatography to isolate pure Ectoin from metabolic precursors, satisfying the most stringent “Clean Beauty” and pharmaceutical purity standards.
8. Pharma-Grade Analytical COA Matrix
8. COA & Quality Control Specifications
8.1 Identity & Assay Specifications
| Item | Specification | Test Method |
|---|---|---|
| Product Name | Ectoin | Internal Specification |
| CAS Number | 96702-03-3 | Reference Standard |
| Molecular Formula | C6H10N2O2 | Reference Standard |
| Molecular Weight | 142.15 | Reference Standard |
| Appearance | White Crystalline Powder | Visual |
| Odor | Characteristic | Organoleptic |
| Solubility | Freely Soluble in Water | USP |
| Identification | Positive | HPLC |
| Assay (Ectoin) | ≥ 99.0% | HPLC |
| Chromatographic Purity | ≥ 99.5% | HPLC |
| pH (5% Solution) | 6.0 – 8.0 | USP |
| UV Spectrum | Conforms | UV-Vis |
8.2 Physical & Flowability Analysis
| Item | Specification | Test Method |
|---|---|---|
| Bulk Density | 0.40 – 0.70 g/mL | USP <616> |
| Tapped Density | 0.50 – 0.85 g/mL | USP <616> |
| Carr Compressibility Index | ≤ 20% | USP <1174> |
| Hausner Ratio | ≤ 1.25 | USP <1174> |
| Angle of Repose | ≤ 35° | Powder Flow Analysis |
| Particle Size D90 | ≤ 80 μm | Laser Diffraction |
| Mesh Size | 100% Pass 80 Mesh | USP <786> |
| Flowability | Free-Flowing Powder | Internal SOP |
| Hygroscopicity | Slightly Hygroscopic | Stability Simulation |
| Compressibility | Moderate | Powder Rheometer |
8.3 Chemical & Stability Parameters
| Item | Specification | Test Method |
|---|---|---|
| Moisture Content | ≤ 1.0% | Karl Fischer |
| Loss on Drying | ≤ 1.0% | USP <731> |
| Sulfated Ash | ≤ 0.1% | USP <281> |
| Residual Solvents | Complies USP <467> | GC |
| Ethanol Residue | ≤ 300 ppm | GC |
| Methanol Residue | ≤ 50 ppm | GC |
| Peroxide Value | ≤ 5.0 meq/kg | AOAC |
| Thermal Stability | Stable Below 80°C | DSC Analysis |
| Light Stability | No Significant Degradation | ICH Q1B |
| Solution Stability (24h) | ≥ 98% Retention | HPLC |
| Accelerated Stability (40°C / 75% RH / 6 Months) | ≥ 98.0% Assay Retention | ICH Q1A |
| Freeze-Thaw Stability | Pass 3 Cycles | Internal Stability Protocol |
8.4 Heavy Metal Control
| Item | Specification Limit | Test Method |
|---|---|---|
| Lead (Pb) | ≤ 1.0 ppm | ICP-MS / USP <233> |
| Arsenic (As) | ≤ 1.0 ppm | ICP-MS / USP <233> |
| Cadmium (Cd) | ≤ 0.3 ppm | ICP-MS / USP <233> |
| Mercury (Hg) | ≤ 0.2 ppm | ICP-MS / USP <233> |
| Nickel (Ni) | ≤ 1.0 ppm | ICP-MS |
| Chromium (Cr) | ≤ 2.0 ppm | ICP-MS |
| Total Heavy Metals | ≤ 10 ppm | ICP-MS |
8.5 Pesticide Residue Screening
| Item | Specification Limit | Test Method |
|---|---|---|
| Benzene Hexachloride (BHC) | NMT 0.1 ppm | GC-MS/MS |
| DDT | NMT 0.1 ppm | GC-MS/MS |
| Aldrin | NMT 0.02 ppm | GC-MS/MS |
| Endrin | NMT 0.02 ppm | GC-MS/MS |
| Heptachlor | NMT 0.02 ppm | GC-MS/MS |
| Chlorpyrifos | NMT 0.05 ppm | GC-MS/MS |
| Diazinon | NMT 0.05 ppm | GC-MS/MS |
| Malathion | NMT 0.05 ppm | GC-MS/MS |
| Cypermethrin | NMT 0.1 ppm | GC-MS/MS |
| Permethrin | NMT 0.1 ppm | GC-MS/MS |
| Organophosphorus Residues | ≤ 0.5 ppm | USP <561> |
| Total Pesticide Residues | Complies USP & EP | GC-MS/MS |
8.6 Microbiological Specifications
| Item | Specification Limit | Test Method |
|---|---|---|
| Total Plate Count | ≤ 1,000 CFU/g | USP <61> |
| Total Yeast & Mold | ≤ 100 CFU/g | USP <61> |
| Escherichia coli | Negative / 25g | USP <62> |
| Salmonella spp. | Negative / 25g | USP <62> |
| Staphylococcus aureus | Negative / 25g | USP <62> |
| Pseudomonas aeruginosa | Negative / 25g | USP <62> |
| Enterobacteriaceae | ≤ 10 CFU/g | USP <62> |
| Total Coliforms | ≤ 100 CFU/g | AOAC |
| Thermotolerant Coliforms | Negative | USP <62> |
| Aflatoxin B1 | ≤ 2 ppb | HPLC-FLD |
| Total Aflatoxins | ≤ 4 ppb | HPLC-FLD |
Batch Consistency & Analytical Fingerprinting
Every industrial lot is released after HPLC-DAD Purity Verification. Accelerated stability testing (40°C/75% RH) confirm >99% active retention over 180 days. We provide batch-to-batch reproducibility data for large-scale contract manufacturing.
9. Manufacturing Flow Description
10. Storage & Packaging
Packed in 25kg standard fiber drums with light-proof PE liners. Store below 25°C. Ectoin is non-hygroscopic, but airtight sealing is mandatory to preserve the crystalline morphology.
11. MOQ, Sample & Global Shipping
MOQ: 25kg bulk. 100g samples available with full batch COA. Global dispatch within 3-5 days from Shaanxi hub. Certified DDP/CIF terms.
12. Scientific Research & Clinical Data
In vivo studies demonstrate that 1.0% Ectoin significantly upregulates the synthesis of natural moisturizing factors (NMF) in the stratum corneum. Research confirm its status as a superior protectant against heat-induced protein denaturation.
13. Applicable Industries
Ophthalmics
Sensitive Baby Care
16. Supplier Comparison & Procurement Guide
| Metric | Standard Trader Grade | Exbiol® Phyto-Engineering |
|---|---|---|
| Purity Verification | Basic HPLC | Chiral Isomer Verification |
| Stability Profile | Ambient data only | pH 1–13 Stress Data Provided |
| Traceability | Broker Sourcing | Direct GMP Factory Hub |
17. Technical FAQ for Bulk Buyers
Does Exbiol Ectoin comply with COSMOS standards?
Yes, our Ectoin is produced via natural fermentation and complies with the COSMOS standard for natural and organic cosmetics.
What analytical method verifies its extremolyte identity?
We utilize H-NMR and LC-MS to confirm the chemical structure and FTIR Overlay to verify batch identity against our primary halophilic reference standard.
18. References & Regulatory Sources
- PubMed: Ectoin as a multi-functional stabilizer of cells.
- FDA: GRAS Notice Database (GRN No. 734).
- ICH Q3A: Impurities in New Drug Substances.
Exbiol® Quality Assurance
Manufactured by Shaanxi Zhonghong Investment Technology Co., Ltd. 100% batch traceability from fermentation tank to fiber drum. ISO 9001 & GMP Certified.
✔ 5,000kg Bulk Stock
✔ OEM/ODM Customization
