High-Quality Safety Injection Grade Sodium Hyaluronate Powder Low Endotoxin Suppliers, Factory

Sodium hyaluronate, also known as hyaluronic acid sodium salt, is a natural mucopolysaccharide widely found in human connective tissue. Our injectable-grade products are manufactured using advanced streptococcal fermentation technology, combined with stringent purification techniques, ensuring that the products fully comply with the standards of major global pharmacopoeias.

Product Description

Product Specification

Product Name Sodium Hyaluronate
Chemical Formula (C14H20NNaO11)n
Chemical Structure
Chemical Structure of Sodium Hyaluronate
CAS No. 9067-32-7
Appearance White, fine powder
Assay 95.0%~105.0%
Solubility Soluble in water
Heavy metals ≤10ppm
Protein ≤0.1%
Bacterial endotoxins ≤0.05IU/mg
Source Microbial fermentation

Product Advantages

1. Ultra-Low Endotoxin Levels
Endotoxins are a major cause of post-injection inflammatory responses. Our patented purification process keeps endotoxin levels extremely low, significantly reducing immunogenicity and sensitization risks in clinical applications, making it ideal for developing ophthalmic surgical adjuvants and intra-articular injections.
2. High Biocompatibility & Non-GMO
Sodium hyaluronate is produced using a non-animal-derived fermentation method, avoiding the risk of animal-borne virus transmission. Its chemical structure is completely identical to naturally occurring hyaluronic acid in the human body, exhibiting excellent tissue compatibility.
3. Precise Molecular Weight
We offer a full range of products from low to ultra-high molecular weight. Whether you require highly viscoelastic joint lubricants or rapidly penetrating bio-scaffold materials, we can provide customized solutions with extremely narrow molecular weight distributions.

Application Areas

Medical Aesthetics: Dermal Fillers, hyaluronic acid injections, mesotherapy.
Ophthalmic Surgery: Oval Radiators (OVDs) for cataract and glaucoma surgery.
Orthopedic Treatment: Intra-articular injections to relieve friction in osteoarthritis.
Anti-adhesion Products: Postoperative anti-adhesion gels.
Drug Delivery: As a carrier for sustained-release drug systems.

Quality System and Certification

Compliance
Fully supported by comprehensive CEP and DMF documentation for global regulatory submissions.
Traceability
Complete digital traceability tracking the process from strain selection to finished product packaging.
Stability
Undergoes rigorous stability testing to ensure high product performance remains stable throughout shelf life.

Frequently Asked Questions

Q1: What are the main differences between injectable grade and cosmetic grade sodium hyaluronate?
A1: The most crucial difference lies in the endotoxin level and purity. Injectable grade products must be manufactured in a GMP-compliant sterile environment, and their endotoxin content is typically several orders of magnitude lower than that of cosmetic grade products to ensure safety after entering the human circulation.
Q2: What are the storage conditions and shelf life of sodium hyaluronate?
A2: It is recommended to store it refrigerated at 2°C-8°C, sealed, and protected from light. The shelf life is typically 24 months. Strict moisture protection is required.
Q3: How do you ensure batch stability?
A3: We have a fully automated fermentation monitoring system and a comprehensive quality management system to ensure a high degree of consistency in molecular weight distribution and purity between different batches of products.
Q4: Is your Sodium Hyaluronate derived from animal sources?
A4: No, our Sodium Hyaluronate is produced through microbial fermentation using non-animal raw materials, eliminating any risk of animal-derived pathogen transmissions.
Q5: Can you customize specific molecular weights?
A5: Yes, we provide a wide range of molecular weights (from low to ultra-high) with narrow molecular weight distributions to match your specific formulation and viscosity requirements.
Q6: What documentation is available for regulatory registration?
A6: We provide full regulatory support with CEP (Certificate of Suitability) and DMF (Drug Master File) documentation to facilitate smooth regulatory approvals for your pharmaceutical products.

Related Products