Single-crosslinked sodium hyaluronate
RUNXIN BIOTECH
| Quantity: | |
|---|---|
Manufacturer Profile: Runxin BioTech – Three Decades of Crosslinking Innovation
Since 1998, Runxin BioTech has established itself as a global leader in advanced hyaluronic acid technologies, specializing in crosslinked sodium hyaluronate manufacturing. Our 28-year journey has been marked by continuous innovation in medical-grade HA production, with facilities certified under cGMP, IS09001, IS022000, IS013485, HACCP, HALAL, FSSC22000. Serving pharmaceutical companies, medical device manufacturers, and aesthetic clinics across 60+ countries, we combine scientific expertise with industrial-scale manufacturing capabilities to deliver consistently superior crosslinked HA products.
Product Overview: Single-Crosslinked Sodium Hyaluronate
Runxin's Single-Crosslinked Sodium Hyaluronate represents a breakthrough in controlled molecular modification technology. Through precise crosslinking using BDDE (1,4-Butanediol diglycidyl ether) under optimized reaction conditions, we create a stable three-dimensional network that significantly enhances the material's resistance to enzymatic degradation and mechanical stress. This medical-grade product maintains excellent biocompatibility while offering extended duration in vivo, making it ideal for dermal fillers, tissue engineering, and advanced medical applications requiring prolonged residence time.
Key Advantages
Controlled Degradation Profile: Extended residence time up to 6-12 months in tissue applications
Enhanced Mechanical Strength: Improved resistance to compression and shear forces
Optimal Viscoelasticity: Balanced G-prime and G-double prime values for natural tissue integration
Minimal Crosslinker Residues: BDDE residue levels <2 ppm, exceeding safety standards
Reproducible Crosslinking Density: Consistent modification degree between 2-4% across batches
Technical Specifications
Appearance: White elastic hydrogel particles
pH (1% solution): 5.0 - 8.5
Protein Content: ≤0.1%
Microbiological Limits: Total plate count <100 CFU/g; Staphylococcus aureus，Pseudomonas aeruginosa，Thermotolerant Coliform Bacteria not detectable
Storage conditions: Store in a well-ventilated and dry place, sealed, at 2-10℃. Do not store together with toxic or harmful substances.
Solubility: Fully soluble in water
Certifications: cGMP,IS09001,IS022000,IS013485,HACCP,HALAL,FSSC22000
Applications
Dermal fillers for aesthetic medicine
Tissue engineering scaffolds
Osteoarthritis injection formulations
Adhesion prevention barriers
Drug delivery systems with sustained release
Wound healing matrices
FAQs About Single-Crosslinked Sodium Hyaluronate
What is single-crosslinked sodium hyaluronate and how does it differ from linear HA?
Single-crosslinked HA undergoes controlled chemical bonding between HA chains using BDDE, creating a stable 3D network that resists enzymatic breakdown and provides longer-lasting effects compared to linear HA.
What safety standards do you maintain for crosslinker residues?
We maintain BDDE residue levels below 2 ppm through advanced purification technology, significantly below the 10 ppm limit set by major regulatory authorities.
Can you customize crosslinking density for specific applications?
Yes, we offer precise control over crosslinking density (1-6%) to tailor degradation rates and mechanical properties for specific clinical requirements.
What is the typical shelf life of your crosslinked HA products?
Our single-crosslinked HA maintains stability for 36 months when stored under recommended conditions, with validated sterility throughout the shelf life.
Do you provide technical support for regulatory submissions?
We offer comprehensive regulatory support including DMF references, biocompatibility testing data, and complete manufacturing documentation for global market approvals.
Why Choose Runxin's 28 Years of Crosslinking Expertise
Pioneering technology in controlled crosslinking since 1998
Medical-grade manufacturing with full quality traceability
Customized solutions for specific clinical applications
Global regulatory compliance support
Scale-up capabilities from R&D to commercial volumes
Partner with the Crosslinking Technology Pioneer
Leverage our 28 years of expertise in advanced HA modification for your medical applications. Contact Runxin today to discuss your project requirements, request samples, or schedule a technical consultation. Experience the difference that comes with nearly three decades of focused innovation in crosslinked hyaluronic acid technology.
Manufacturer Profile: Runxin BioTech – Three Decades of Crosslinking Innovation
Since 1998, Runxin BioTech has established itself as a global leader in advanced hyaluronic acid technologies, specializing in crosslinked sodium hyaluronate manufacturing. Our 28-year journey has been marked by continuous innovation in medical-grade HA production, with facilities certified under cGMP, IS09001, IS022000, IS013485, HACCP, HALAL, FSSC22000. Serving pharmaceutical companies, medical device manufacturers, and aesthetic clinics across 60+ countries, we combine scientific expertise with industrial-scale manufacturing capabilities to deliver consistently superior crosslinked HA products.
Product Overview: Single-Crosslinked Sodium Hyaluronate
Runxin's Single-Crosslinked Sodium Hyaluronate represents a breakthrough in controlled molecular modification technology. Through precise crosslinking using BDDE (1,4-Butanediol diglycidyl ether) under optimized reaction conditions, we create a stable three-dimensional network that significantly enhances the material's resistance to enzymatic degradation and mechanical stress. This medical-grade product maintains excellent biocompatibility while offering extended duration in vivo, making it ideal for dermal fillers, tissue engineering, and advanced medical applications requiring prolonged residence time.
Key Advantages
Controlled Degradation Profile: Extended residence time up to 6-12 months in tissue applications
Enhanced Mechanical Strength: Improved resistance to compression and shear forces
Optimal Viscoelasticity: Balanced G-prime and G-double prime values for natural tissue integration
Minimal Crosslinker Residues: BDDE residue levels <2 ppm, exceeding safety standards
Reproducible Crosslinking Density: Consistent modification degree between 2-4% across batches
Technical Specifications
Appearance: White elastic hydrogel particles
pH (1% solution): 5.0 - 8.5
Protein Content: ≤0.1%
Microbiological Limits: Total plate count <100 CFU/g; Staphylococcus aureus，Pseudomonas aeruginosa，Thermotolerant Coliform Bacteria not detectable
Storage conditions: Store in a well-ventilated and dry place, sealed, at 2-10℃. Do not store together with toxic or harmful substances.
Solubility: Fully soluble in water
Certifications: cGMP,IS09001,IS022000,IS013485,HACCP,HALAL,FSSC22000
Applications
Dermal fillers for aesthetic medicine
Tissue engineering scaffolds
Osteoarthritis injection formulations
Adhesion prevention barriers
Drug delivery systems with sustained release
Wound healing matrices
FAQs About Single-Crosslinked Sodium Hyaluronate
What is single-crosslinked sodium hyaluronate and how does it differ from linear HA?
Single-crosslinked HA undergoes controlled chemical bonding between HA chains using BDDE, creating a stable 3D network that resists enzymatic breakdown and provides longer-lasting effects compared to linear HA.
What safety standards do you maintain for crosslinker residues?
We maintain BDDE residue levels below 2 ppm through advanced purification technology, significantly below the 10 ppm limit set by major regulatory authorities.
Can you customize crosslinking density for specific applications?
Yes, we offer precise control over crosslinking density (1-6%) to tailor degradation rates and mechanical properties for specific clinical requirements.
What is the typical shelf life of your crosslinked HA products?
Our single-crosslinked HA maintains stability for 36 months when stored under recommended conditions, with validated sterility throughout the shelf life.
Do you provide technical support for regulatory submissions?
We offer comprehensive regulatory support including DMF references, biocompatibility testing data, and complete manufacturing documentation for global market approvals.
Why Choose Runxin's 28 Years of Crosslinking Expertise
Pioneering technology in controlled crosslinking since 1998
Medical-grade manufacturing with full quality traceability
Customized solutions for specific clinical applications
Global regulatory compliance support
Scale-up capabilities from R&D to commercial volumes
Partner with the Crosslinking Technology Pioneer
Leverage our 28 years of expertise in advanced HA modification for your medical applications. Contact Runxin today to discuss your project requirements, request samples, or schedule a technical consultation. Experience the difference that comes with nearly three decades of focused innovation in crosslinked hyaluronic acid technology.
