Pharmaceutical-grade sodium hyaluronate
RUNXIN BIOTECH
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Manufacturer Profile: Runxin BioTech – Setting Pharmaceutical Standards Since 1998
Runxin BioTech stands as a globally recognized manufacturer specializing in pharmaceutical-grade sodium hyaluronate and chondroitin sulfate. With over 28 years of expertise, our advanced manufacturing facilities operate under strict cGMP, IS09001, IS022000, IS013485, HACCP, HALAL, FSSC22000. Serving 3,000+ clients across 60+ countries, we combine state-of-the-art purification technology with rigorous quality control protocols to deliver premium ingredients for pharmaceutical, medical device, and advanced therapeutic applications.
Product Overview: Low Endotoxin Sodium Hyaluronate
Runxin's Low Endotoxin Sodium Hyaluronate represents the pinnacle of pharmaceutical-grade quality, specifically engineered for sensitive medical applications. This ultra-pure raw material undergoes specialized purification processes including tangential flow filtration, endotoxin removal columns, and validated sterilization methods to ensure exceptional safety profiles. The product features controlled molecular weight distributions and meets stringent international pharmacopeia standards, making it ideal for injectable formulations, medical devices, and advanced therapeutic applications.
Key Advantages
Ultra-Low Endotoxin Levels: Consistently maintained at<0.05 IU/mg , exceeding pharmacopeia requirements
Validated Sterilization: Gamma irradiation and sterile filtration options available
Enhanced Safety Profile: Comprehensive impurity control with protein content <0.005%
Batch-to-Batch Consistency: Rigorous quality control ensures reproducible performance
Global Compliance: Meets USP, EP, JP, and ChP standards for pharmaceutical applications
Technical Specifications
Appearance: White fibrous sterile powder
Endotoxin Level: <0.05 IU/mg
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
Injectable formulations and parenteral products
Ophthalmic surgical viscoelastic devices
Advanced wound care and tissue engineering
Medical device coatings and formulations
Orthopedic injections and joint lubricants
Advanced drug delivery systems
FAQs About Pharmaceutical-Grade Sodium Hyaluronate
What distinguishes pharmaceutical-grade sodium hyaluronate from other grades?
Pharmaceutical-grade HA undergoes additional purification processes including endotoxin removal, sterility assurance, and meets strict pharmacopeia standards (USP/EP/JP), ensuring safety for medical and injectable applications.
What endotoxin levels are acceptable for injectable applications?
Our low endotoxin HA maintains levels <0.001 EU/mg, significantly below the typical limit of 0.05 EU/mg for injectable products, ensuring maximum safety for sensitive applications.
Can you provide custom molecular weights for specific medical applications?
Yes, we offer customized molecular weight ranges from 50,000 to 3,000,000 Da, optimized for specific applications such as ophthalmic surgery, joint injections, or advanced drug delivery systems.
What documentation package do you provide for regulatory submissions?
We supply comprehensive documentation including DMF references, Certificate of Analysis, sterilization validation reports, and full traceability from raw materials to finished product.
How does your quality control ensure batch-to-batch consistency?
Our multi-stage QC process includes in-process testing, finished product characterization, and stability studies, ensuring consistent molecular weight, purity, and performance across all batches.
Why Choose Runxin BioTech
28+ years of pharmaceutical manufacturing expertise
Complete regulatory support with active DMF filings
State-of-the-art purification and sterilization capabilities
Customized solutions for specific medical applications
Global compliance with major pharmacopeia standards
Advance Your Pharmaceutical Innovations with Confidence
Partner with Runxin for your critical medical applications. Contact us today to request samples, technical documentation, or schedule a consultation with our pharmaceutical experts. Experience the assurance that comes with 25 years of pharmaceutical-grade manufacturing excellence and uncompromising quality standards.
Manufacturer Profile: Runxin BioTech – Setting Pharmaceutical Standards Since 1998
Runxin BioTech stands as a globally recognized manufacturer specializing in pharmaceutical-grade sodium hyaluronate and chondroitin sulfate. With over 28 years of expertise, our advanced manufacturing facilities operate under strict cGMP, IS09001, IS022000, IS013485, HACCP, HALAL, FSSC22000. Serving 3,000+ clients across 60+ countries, we combine state-of-the-art purification technology with rigorous quality control protocols to deliver premium ingredients for pharmaceutical, medical device, and advanced therapeutic applications.
Product Overview: Low Endotoxin Sodium Hyaluronate
Runxin's Low Endotoxin Sodium Hyaluronate represents the pinnacle of pharmaceutical-grade quality, specifically engineered for sensitive medical applications. This ultra-pure raw material undergoes specialized purification processes including tangential flow filtration, endotoxin removal columns, and validated sterilization methods to ensure exceptional safety profiles. The product features controlled molecular weight distributions and meets stringent international pharmacopeia standards, making it ideal for injectable formulations, medical devices, and advanced therapeutic applications.
Key Advantages
Ultra-Low Endotoxin Levels: Consistently maintained at<0.05 IU/mg , exceeding pharmacopeia requirements
Validated Sterilization: Gamma irradiation and sterile filtration options available
Enhanced Safety Profile: Comprehensive impurity control with protein content <0.005%
Batch-to-Batch Consistency: Rigorous quality control ensures reproducible performance
Global Compliance: Meets USP, EP, JP, and ChP standards for pharmaceutical applications
Technical Specifications
Appearance: White fibrous sterile powder
Endotoxin Level: <0.05 IU/mg
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
Injectable formulations and parenteral products
Ophthalmic surgical viscoelastic devices
Advanced wound care and tissue engineering
Medical device coatings and formulations
Orthopedic injections and joint lubricants
Advanced drug delivery systems
FAQs About Pharmaceutical-Grade Sodium Hyaluronate
What distinguishes pharmaceutical-grade sodium hyaluronate from other grades?
Pharmaceutical-grade HA undergoes additional purification processes including endotoxin removal, sterility assurance, and meets strict pharmacopeia standards (USP/EP/JP), ensuring safety for medical and injectable applications.
What endotoxin levels are acceptable for injectable applications?
Our low endotoxin HA maintains levels <0.001 EU/mg, significantly below the typical limit of 0.05 EU/mg for injectable products, ensuring maximum safety for sensitive applications.
Can you provide custom molecular weights for specific medical applications?
Yes, we offer customized molecular weight ranges from 50,000 to 3,000,000 Da, optimized for specific applications such as ophthalmic surgery, joint injections, or advanced drug delivery systems.
What documentation package do you provide for regulatory submissions?
We supply comprehensive documentation including DMF references, Certificate of Analysis, sterilization validation reports, and full traceability from raw materials to finished product.
How does your quality control ensure batch-to-batch consistency?
Our multi-stage QC process includes in-process testing, finished product characterization, and stability studies, ensuring consistent molecular weight, purity, and performance across all batches.
Why Choose Runxin BioTech
28+ years of pharmaceutical manufacturing expertise
Complete regulatory support with active DMF filings
State-of-the-art purification and sterilization capabilities
Customized solutions for specific medical applications
Global compliance with major pharmacopeia standards
Advance Your Pharmaceutical Innovations with Confidence
Partner with Runxin for your critical medical applications. Contact us today to request samples, technical documentation, or schedule a consultation with our pharmaceutical experts. Experience the assurance that comes with 25 years of pharmaceutical-grade manufacturing excellence and uncompromising quality standards.
