Low endotoxin sodium hyaluronate is a highly purified hyaluronic acid material developed for applications with strict biological safety requirements. Produced with advanced purification technology, the material achieves a bacterial endotoxin level of ≤0.05IU/mg, which is lower than the level of standard hyaluronate grades. This specification makes the material suitable for ophthalmic formulations, medical device coatings, and sensitive skin care products.
The material contains ≥95.0% sodium hyaluronate and reaches ≥99.0% transparency. Manufactured under GMP-grade production management and supported by an ISO9001 quality system, it comes with full technical documentation. This raw material provides enterprises in pharmaceutical and cosmetic industries with a high-purity hyaluronic acid source for premium formulation development.
Endotoxins are lipopolysaccharides from bacterial cell walls that may trigger inflammatory or immune responses. For sensitive applications such as eye care products and medical devices, controlled endotoxin levels are a core quality requirement.
This low endotoxin grade limits bacterial endotoxin to ≤0.05IU/mg and protein content to ≤0.1%. These specifications help reduce the risk of inflammation, irritation, and allergic reactions in end products, supporting a higher safety profile for sensitive use cases.
Feature | Low Endotoxin HA | Regular HA |
|---|---|---|
Endotoxin Level | Ultra-low | Standard |
Safety | Very high | Moderate |
Application | Medical / High-end | General cosmetics |
Purity | Higher | Standard |
Test Items | Requirements |
|---|---|
Appearance | White powder or granules |
Identification (IR) | The infrared absorption spectrum of the sample should be consistent with the reference spectrum |
Sodium Identification | Should show a positive reaction for sodium salts |
Odor | Odorless |
Glucuronic Acid | ≥ 45.0% |
Sodium Hyaluronate Content | ≥ 95.0% |
Bacterial endotoxin | ≤0.05IU/mg |
Protein | ≤0.1% |
Average Molecular Weight | Measured values(customizable) |
Intrinsic Viscosity | Measured values |
Kinematic Viscosity | Measured values |
Absorbance (280 nm) | ≤ 0.25 |
Transparency | ≥ 99.0% |
Loss on Drying | ≤ 10.0% |
pH (1% solution) | 6.0 – 8.0 |
Protein Content | ≤ 0.10% |
Ash Content | ≤ 13.0% |
Physical Properties | |
Particle Size | 80 mesh (customizable) |
Bulk Density | Measured values |
Heavy Metals | |
Heavy Metals (as Pb) | ≤ 10 mg/kg |
Lead (Pb) | ≤ 1 mg/kg |
Arsenic (As) | ≤ 2 mg/kg |
Mercury (Hg) | ≤ 0.1 mg/kg |
Chromium (Cr) | ≤ 1 mg/kg |
Microbiological | |
Total Plate Count | ≤ 100 CFU/g |
Yeast & Mold | ≤ 50 CFU/g |
Staphylococcus aureus | Negative |
Pseudomonas aeruginosa | Negative |
Hemolytic Streptococcus | Negative |
This material serves as a raw material for multiple medical and pharmaceutical production scenarios:
Ophthalmic formulations such as eye drops
Injectable product raw materials for intermediate use
Coatings for medical devices
For cosmetic manufacturers targeting premium and sensitive skin lines, the material fits into:
Sensitive skin care products
Premium serums
Skin repair and barrier-enhancing formulations
Production follows GMP-grade process management, and the quality system is certified under ISO9001 standards. Each batch comes with corresponding test reports and full technical documentation to support commercial procurement compliance reviews.
Average molecular weight and particle size support customization. The default particle size is 80 mesh, and adjustments can be made according to specific formulation requirements.
Technical support for formulation development is provided for enterprise customers, including raw material compatibility guidance and formulation adaptation suggestions.
For bulk procurement inquiries, sample requests, or full technical dossiers, contact our team for customized supply solutions for commercial production.
