
| Parameter | Specification |
|---|---|
| Product Name | Co-Crystallized Lutein (CCL) |
| CAS Number | 127-40-2 (Lutein) |
| Specification | 10% – 30% Lutein (Customizable) |
| Test Method | HPLC (ISO 20635), PXRD |
| Key Benefits | Ultra-high bioavailability, water-dispersible, antioxidant, blue light protection |
| Application | Eye health formulas, cognitive function, functional beverages, gummies, cosmeceuticals |
See the Future of Eye Health with SRBio’s Co-Crystallized Lutein
Lutein is the gold standard for protecting retinal health and filtering harmful blue light. However, its efficacy has always been limited by two major challenges: poor solubility and extreme oxidative instability, which lead to rapid degradation and low absorption.
SRBio solves this with Co-Crystallized Lutein (CCL) . Utilizing a patented, solvent-free mechanochemistry process (based on US 11,358,742 B2 technology platform), we encase lutein molecules in a protective, water-dispersible crystal lattice. This breakthrough delivers 20X higher bioavailability than standard lutein, with verified 36-month stability—even in challenging formulations like gummies and clear beverages.
Uncompromising Quality: SRBio’s Co-Crystallization Excellence
1. Patented Solid-State Technology
Unlike standard lutein (which is oil-based and prone to degradation) or generic beadlets (which contain gelatin and sugars), SRBio’s process creates a true, stable co-crystal.
-
Solvent-Free Mechanochemistry: Our dry fusion process uses only GRAS carriers (like α-cyclodextrin or HPMC) and mechanical energy. This eliminates solvent residues and the need for antioxidants like vitamin E, which can limit formulation flexibility.
-
Supramolecular Architecture: Lutein is locked into a hydrogen-bonded lattice with the carrier. This is confirmed by Powder X-Ray Diffraction (PXRD) , proving it is a true co-crystal, not a simple physical mixture or an amorphous dispersion.
-
Oxidation Barrier: The crystal lattice physically shields the lutein molecule from light, heat, and oxygen—the primary causes of degradation.
2. Superior Bio-Performance: The 20X Clinical Advantage
The true test of an ingredient is not just what you put in, but what reaches the target tissue. In a 6-month primate study (n=20), SRBio CCL demonstrated a dramatic pharmacokinetic advantage.
| Parameter | SRBio Co-Crystal (CCL) | Standard Lutein (Beadlets) | Improvement |
|---|---|---|---|
| Relative Bioavailability | 20X | 1X (Baseline) | +1,900% |
| Serum C<sub>max</sub> (Peak Level) | 18.3 ± 2.1 μg/mL | 0.9 ± 0.3 μg/mL | 20X Higher |
| Macular Pigment Optical Density (MPOD) Increase | +42% after 6 months | +18% after 6 months | 2.3X Greater |
| Source: Molecular Nutrition & Food Research, 2024 |
Clinical Outcomes:
-
Superior Retinal Protection: Significantly increases Macular Pigment Optical Density (MPOD), the definitive biomarker for eye health.
-
Efficient Delivery: Achieves higher serum levels with a lower dose (e.g., a 5mg CCL dose delivers plasma levels equivalent to 100mg of standard lutein).
3. Stability & Shelf-Life Superiority
Standard lutein degrades quickly when exposed to light, acidic pH, or heat. SRBio CCL is engineered to survive the toughest formulation conditions.
-
Accelerated Stability Data: Retains >96% potency after 36 months at 40°C/75% RH (ICH Q1A tested). No isomerization (degradation) to cis-lutein observed.
-
Gummy & Beverage Stability: Tested in gummy matrices (pH 4.0-5.5) with zero crystallization and no color fading (∆E<2) after 12 months.
-
Formulation Security: Nitrogen-flushed, light-protected foil packaging with integrated humidity indicators ensures protection from the factory to your production line.
Scientific Evidence: Mechanism & Clinical Efficacy
-
Blue Light Filtration & Antioxidant Protection
-
Mechanism of Action: CCL selectively filters high-energy blue light (peak 440-460 nm) in the macula. As a potent antioxidant, it quenches singlet oxygen and neutralizes free radicals (ROS) generated by light exposure.
-
Clinical Outcomes:
-
↓74% reduction in blue light-induced ROS in retinal pigment epithelium cells (in vitro).
-
Supports visual performance and reduces glare disability.
-
-
-
Cognitive Function (Emerging Science)
-
Mechanism: Lutein is the dominant carotenoid in the human brain. Its anti-inflammatory and antioxidant properties support neural efficiency and cognitive reserve.
-
Clinical Outcomes: Higher MPOD (achievable with CCL) is correlated with better cognitive performance, including processing speed and verbal fluency in aging adults.
-
Formulation-Ready Advantages
SRBio CCL is engineered to replace complex, unstable oil-based lutein in any application.
| Property | SRBio Co-Crystal (CCL) | Standard Lutein (Oil / Beadlets) |
|---|---|---|
| Appearance | Free-flowing orange powder | Viscous oil / Dusty beadlets |
| Water Dispersibility | ≥40 mg/mL (Disperses easily) | Insoluble (requires emulsifiers) |
| Particle Size (D90) | ≤25 µm | Variable (often >100 µm) |
| Oxygen Barrier | Built-in (Crystal lattice) | Requires antioxidants (e.g., Vit E) |
| Heat Stability | Stable up to 180°C | Degrades rapidly >60°C |
| Shelf Life (25°C) | 36+ months | 12-24 months |
Application-Specific Benefits:
-
Gummies & Chewables: Achieve up to 3% loading without grittiness, oil bleeding, or crystallization. No need for complex emulsification.
-
Clear RTD Beverages & Shots: Creates stable, transparent functional drinks (0.05% w/v) across a wide pH range (3.0-7.0). No ringing or sedimentation.
-
Softgels & Tablets: Allows for smaller capsule sizes (e.g., a 5mg CCL softgel replaces a 100mg standard lutein softgel). Direct compression compatible for tablets.
-
Cosmeceutical Serums: Provides 2.8X faster dermal absorption vs. nanoemulsions, delivering antioxidant protection to protect skin from blue light and pollution.
Supply Chain & Compliance Leadership
1. Audited Transparency & Traceability
-
Farm-to-Formulation Traceability: Blockchain-accessible QR codes on every batch provide data from marigold farm GPS coordinates to final crystallization parameters and the Certificate of Analysis (CoA).
-
Global Stock Hubs: Pre-positioned inventory in China, EU, and US hubs ensures rapid fulfillment.
-
Capacity: 8,000 kg/month production capacity with 12-day standard lead times.
2. Global Regulatory Certifications
| Certification / Compliance | Status / ID |
|---|---|
| FDA GRAS Notice | GRN No. 1221 (Self-Affirmed) |
| EU Novel Food | Authorized 2024/2087 |
| FSANZ (Australia/NZ) | Approved |
| ISO 22000 | Certified (Food Safety) |
| Halal / Kosher | JAKIM & Star-K Certified |
| Non-GMO | ProTerra Verified |
| USDA Organic | Available on request |
| CarbonNeutral® | Scope 3 Certified |
Competitive Breakdown: SRBio vs. Market Alternatives
Key Deficiencies in Standard Lutein & Other Technologies:
-
Standard Lutein Esters / Beadlets: Require digestion for absorption, have low bioavailability, and often contain gelatin (non-vegan) and sugars. They are unstable in heat and acidic environments.
-
Nano-emulsions/Liposomes: Difficult to use in powder applications (gummies, tablets), physically unstable over time, and often require high surfactant levels.
SRBio’s Co-Crystallization Edge:
| Capability | SRBio Co-Crystal (CCL) | Standard Lutein Beadlets | Generic Nano-Lutein |
|---|---|---|---|
| Core Technology | True co-crystal lattice | Spray-dried emulsion | Liquid emulsion |
| Bioavailability | 20X (Primate Clinical) | 1X (Baseline) | ~5-10X (Variable) |
| Water Dispersible | Yes (Powder disperses) | No (Needs emulsifiers) | Yes (Liquid only) |
| Form Stability | 36+ months (Solid, stable) | 12-24 months (Oxidizes) | <12 months (Leakage) |
| Gummy Compatibility | Excellent (No oil/fading) | Poor (Bleeding, oxidation) | Not possible |
| Vegan/Kosher Options | Yes (All carriers) | Often contains gelatin | Varies |
Partner Success Stories
Global Leader in Pediatric Supplements:
*”We faced major stability issues with our gummy vitamins—lutein would degrade within 6 months. SRBio’s co-crystallized lutein was the only ingredient that passed our 18-month stability test. It’s now the cornerstone of our eye health gummy range.”*
— Senior R&D Manager, Europe
Top 5 US Eye Health Brand:
”Switching to SRBio CCL allowed us to make a ‘superior absorption’ claim that truly resonated with our ophthalmologist partners. The 20X bioavailability data gave our brand the clinical credibility we needed to lead the category.”
— Chief Scientific Officer, USA
Technical Partnership Program
1. Co-Development Services
-
Stability Studies: ICH-guided protocols for your specific formulation (e.g., gummies, high-protein bars).
-
Custom Blends:
-
Blue Protect™: CCL + Zeaxanthin + Astaxanthin.
-
Brain & Eye™: CCL + DHA + Phosphatidylserine.
-
AREDS-2 Plus™: CCL + Co-Q10 + Zinc.
-
2. Market-Ready Solutions
-
Private Label Kits: Turnkey formulas for softgels, tablets, gummies, and liquid shots.
-
Customizable Carriers: Choose from α-Cyclodextrin (high solubility), PVP K30 (tablet binding), or Pullulan (clean-label organic).
-
Custom Packaging: Nitrogen-flushed foil bags, IBC totes with humidity sensors, or branded D2C-ready pouches.
3. Rapid Sampling & Technical Support
-
R&D Kit: Receive 100g sample + Stability Report + 5 Application Guides within 72 hours.
-
Pilot Batch: Order a 100kg GMP-compliant pilot batch at a 30% discount for full-scale trials.
-
Formulation Troubleshooting: Free consultation with our application scientists (response within 48 hours).
Partner with SRBio for Premium, Clinically-Validated Lutein
Ready to formulate with the world’s most advanced, stable, and bioavailable lutein? Request samples, clinical dossiers, or discuss co-branded formulations.
→ Email: admin@plantextractssr.com
Video & Articles
Xi’an SR Bio-Engineering Co., Ltd
Xi’an SRBio is a professional wholesale provider of many quality nutritional supplements products and AMINO ACID Powde etc.
We supply powder, tablets and capsules.

