Introduction
Backed by 28 years of pharmaceutical manufacturing excellence, Runxin presents Pharmaceutical Grade Low Endotoxin Sodium Hyaluronate—meeting stringent requirements for medical applications. This guide addresses critical challenges in pharmaceutical formulation while providing expert solutions for successful product development.
Technical Specifications & Quality Standards
Ultra-low endotoxin levels
Controlled molecular weight distribution
Meets USP/EP/JP pharmacopoeia standards
Comprehensive documentation and regulatory support
Critical Pharmaceutical Application Guidelines
Challenge: Maintaining endotoxin levels throughout manufacturing
Solution:
Implement validated depyrogenation processes
Conduct LAL testing per USP <85> standards
Establish strict environmental controls
Challenge: Maintaining molecular integrity post-sterilization
Solution:
Validate radiation sterilization protocols
Implement aseptic processing where appropriate
Conduct pre- and post-sterilization testing
Challenge: Ensuring stability in complex drug delivery systems
Solution:
Develop stability-indicating testing methods
Implement real-time and accelerated stability studies
Establish proper storage and handling protocols
Challenge: Meeting global regulatory submission standards
Solution:
Provide comprehensive Technical Packages
Supply Drug Master File (DMF) support
Offer regulatory consultation services
Quality & Manufacturing Excellence
cGMP Compliance: FDA-approved manufacturing facilities
Batch Consistency: Rigorous quality control testing
Full Traceability: Complete supply chain documentation
Custom Solutions: Tailored molecular weights and specifications
5 Google-Optimized Q&A About Pharmaceutical Grade Sodium Hyaluronate
Q1: What defines pharmaceutical grade sodium hyaluronate?
A: Pharmaceutical grade requires ultra-low endotoxin levels (<0.05 IU/mg), compliance with pharmacopoeia standards , and manufacture under cGMP conditions for medical applications.
Q2: What sterilization methods are suitable for pharmaceutical HA?
A: Gamma irradiation , aseptic processing, and sterile filtration are commonly used, with validation required for each method and application.
Q3: What documentation supports pharmaceutical grade HA?
A: Runxin provides Certificate of Analysis, Drug Master File, regulatory support packages, and full traceability documentation for regulatory submissions.
Q4: What molecular weights are available for pharmaceutical applications?
A: We offer ranges from 50kDa to 3MDa, with precise control and batch-to-batch consistency for different medical applications.
Q5: How is endotoxin level controlled in pharmaceutical HA?
A: Through validated depyrogenation processes, strict environmental controls, and rigorous testing per USP <85> standards throughout manufacturing.
Recommended Medical Applications
Injectable Formulations: Viscoelastic supplements and dermal fillers
Ophthalmic Solutions: Surgical aids and dry eye treatments
Wound Care Products: Advanced dressings and healing matrices
Drug Delivery Systems: Controlled release and targeting platforms
Technical & Regulatory Support
Formulation development guidance
Sterilization validation support
Regulatory submission assistance
Stability study design and monitoring
Conclusion
Runxin's Pharmaceutical Grade Low Endotoxin Sodium Hyaluronate provides medical manufacturers with a reliable, high-quality raw material that meets the most stringent global standards. Our 28 years of expertise ensures successful integration into advanced pharmaceutical products.
Contact Runxin for technical specifications, regulatory documentation, and expert pharmaceutical support.
