Bis-Crosslinked Sodium Hyaluronate
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Manufacturer Profile: Runxin Biotech – Advancing Medical-Grade HA Since 1998
Runxin Biotech has been at the forefront of hyaluronic acid innovation for over 28 years, specializing in the development and production of medical-grade sodium hyaluronate and chondroitin sulfate. Our state-of-the-art manufacturing facilities are certified undercGMP, IS09001, IS022000, IS013485, HACCP, HALAL, FSSC22000, ensuring the highest levels of quality, safety, and consistency. With a global clientele spanning 60+ countries, we are trusted by leading pharmaceutical, medical device, and aesthetic industries for advanced HA solutions.
Product Overview: Bis-Crosslinked Sodium Hyaluronate
Runxin’s Bis-Crosslinked Sodium Hyaluronate is a next-generation hydrogel material engineered for superior mechanical strength, extended durability, and enhanced biocompatibility. Utilizing a dual-crosslinking technology with BDDE (1,4-Butanediol diglycidyl ether), this product achieves a highly stable 3D polymer network ideal for long-term medical applications. Its optimized structure ensures exceptional resistance to enzymatic degradation and mechanical stress, making it suitable for demanding clinical uses such as dermal fillers, joint lubricants, and tissue engineering scaffolds.
Key Advantages
Enhanced Longevity: Up to 12–18 months in vivo stability due to robust crosslinked structure.
Superior Mechanical Properties: High elastic modulus (G′) and cohesive strength for natural tissue integration.
Biocompatibility & Safety: Minimal BDDE residues (<1 ppm) and endotoxin levels (<0.05 IU/mg).
Customizable Properties: Adjustable crosslinking density, particle size, and viscosity to meet specific application needs.
NSF Certified: Compliant with NSF/ANSI 173 for safety and quality in medical and dietary supplements.
Technical Specifications
Appearance: Transparent to opalescent hydrogel
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
Long-lasting dermal fillers for aesthetic and reconstructive procedures
Viscosupplementation for osteoarthritis and joint pain management
Drug delivery systems with controlled release profiles
Tissue engineering and regenerative medicine scaffolds
Adhesion barriers in surgical applications
Ophthalmic and wound care hydrogels
FAQs About Bis-Crosslinked Sodium Hyaluronate
What is bis-crosslinked sodium hyaluronate, and how does it differ from single-crosslinked HA?
Bis-crosslinked HA undergoes two stages of crosslinking, creating a denser and more durable 3D network. This results in longer-lasting effects and improved mechanical strength compared to single-crosslinked HA.
Is bis-crosslinked HA safe for sensitive medical applications?
Yes. Our product is manufactured under NSF and cGMP certifications, with BDDE residues maintained below 1 ppm and endotoxin levels under 0.001 EU/mg, ensuring exceptional safety for medical use.
Can the degradation time of bis-crosslinked HA be customized?
Absolutely. We offer tailored crosslinking density and molecular configurations to achieve specific degradation profiles, ranging from 6 to 18 months.
What documentation and support do you provide for regulatory approvals?
We supply DMF references, NSF certification, biocompatibility test reports, and full technical documentation to support FDA, CE, and other global regulatory submissions.
How does bis-crosslinked HA perform in high-stress applications like joint injections?
Its high elastic modulus and cohesive properties provide excellent shock absorption and durability, making it ideal for joint lubrication and viscosupplementation.
Why Choose Runxin Biotech
28+ years of expertise in medical-grade HA R&D and production
NSF-certified manufacturing with global regulatory compliance
Customized solutions for advanced medical and aesthetic applications
End-to-end technical and regulatory support
Innovate with Confidence Using Runxin’s Bis-Crosslinked HA
Elevate your medical and aesthetic products with Runxin’s certified bis-crosslinked sodium hyaluronate. Contact us today to request samples, technical data, or schedule a consultation with our experts. Partner with a pioneer in HA innovation to bring safe, effective, and durable solutions to the global market.
Manufacturer Profile: Runxin Biotech – Advancing Medical-Grade HA Since 1998
Runxin Biotech has been at the forefront of hyaluronic acid innovation for over 28 years, specializing in the development and production of medical-grade sodium hyaluronate and chondroitin sulfate. Our state-of-the-art manufacturing facilities are certified undercGMP, IS09001, IS022000, IS013485, HACCP, HALAL, FSSC22000, ensuring the highest levels of quality, safety, and consistency. With a global clientele spanning 60+ countries, we are trusted by leading pharmaceutical, medical device, and aesthetic industries for advanced HA solutions.
Product Overview: Bis-Crosslinked Sodium Hyaluronate
Runxin’s Bis-Crosslinked Sodium Hyaluronate is a next-generation hydrogel material engineered for superior mechanical strength, extended durability, and enhanced biocompatibility. Utilizing a dual-crosslinking technology with BDDE (1,4-Butanediol diglycidyl ether), this product achieves a highly stable 3D polymer network ideal for long-term medical applications. Its optimized structure ensures exceptional resistance to enzymatic degradation and mechanical stress, making it suitable for demanding clinical uses such as dermal fillers, joint lubricants, and tissue engineering scaffolds.
Key Advantages
Enhanced Longevity: Up to 12–18 months in vivo stability due to robust crosslinked structure.
Superior Mechanical Properties: High elastic modulus (G′) and cohesive strength for natural tissue integration.
Biocompatibility & Safety: Minimal BDDE residues (<1 ppm) and endotoxin levels (<0.05 IU/mg).
Customizable Properties: Adjustable crosslinking density, particle size, and viscosity to meet specific application needs.
NSF Certified: Compliant with NSF/ANSI 173 for safety and quality in medical and dietary supplements.
Technical Specifications
Appearance: Transparent to opalescent hydrogel
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
Long-lasting dermal fillers for aesthetic and reconstructive procedures
Viscosupplementation for osteoarthritis and joint pain management
Drug delivery systems with controlled release profiles
Tissue engineering and regenerative medicine scaffolds
Adhesion barriers in surgical applications
Ophthalmic and wound care hydrogels
FAQs About Bis-Crosslinked Sodium Hyaluronate
What is bis-crosslinked sodium hyaluronate, and how does it differ from single-crosslinked HA?
Bis-crosslinked HA undergoes two stages of crosslinking, creating a denser and more durable 3D network. This results in longer-lasting effects and improved mechanical strength compared to single-crosslinked HA.
Is bis-crosslinked HA safe for sensitive medical applications?
Yes. Our product is manufactured under NSF and cGMP certifications, with BDDE residues maintained below 1 ppm and endotoxin levels under 0.001 EU/mg, ensuring exceptional safety for medical use.
Can the degradation time of bis-crosslinked HA be customized?
Absolutely. We offer tailored crosslinking density and molecular configurations to achieve specific degradation profiles, ranging from 6 to 18 months.
What documentation and support do you provide for regulatory approvals?
We supply DMF references, NSF certification, biocompatibility test reports, and full technical documentation to support FDA, CE, and other global regulatory submissions.
How does bis-crosslinked HA perform in high-stress applications like joint injections?
Its high elastic modulus and cohesive properties provide excellent shock absorption and durability, making it ideal for joint lubrication and viscosupplementation.
Why Choose Runxin Biotech
28+ years of expertise in medical-grade HA R&D and production
NSF-certified manufacturing with global regulatory compliance
Customized solutions for advanced medical and aesthetic applications
End-to-end technical and regulatory support
Innovate with Confidence Using Runxin’s Bis-Crosslinked HA
Elevate your medical and aesthetic products with Runxin’s certified bis-crosslinked sodium hyaluronate. Contact us today to request samples, technical data, or schedule a consultation with our experts. Partner with a pioneer in HA innovation to bring safe, effective, and durable solutions to the global market.
