Highest-grade specification based on Ph.Eur. 11.0 with the strictest endotoxin limit (< 0.05 IU/mg) for parenteral applications. Actual COA provided per batch upon request.
| Test Item | Specification | Test Method | Remarks |
|---|---|---|---|
| Identification & Appearance | |||
| Appearance | White or almost white powder or granule | ||
| Identification A (IR) | Conforms to Ph.Eur. reference spectrum | ||
| Identification B (Na) | Positive reaction of sodium | ||
| Appearance of Solution | Clear; A₆₀₀ₙₘ ≤ 0.01 | ||
| Chemical Assay | |||
| Assay (Sodium Hyaluronate) | 95.0% – 105.0% | ||
| Intrinsic Viscosity | Measured value (reported) | ||
| Average Molecular Weight | Per grade specification | ||
| Physical & Chemical Properties | |||
| pH (0.5% solution, 25°C) | 5.0 – 8.5 | ||
| Loss on Drying | ≤ 20.0% | ||
| Protein Content | ≤ 0.1% | ||
| Chlorides | ≤ 0.5% | ||
| Iron | ≤ 80 ppm | ||
| Nucleic Acids | A₂₆₀ₙₘ ≤ 0.05 | ||
| Residual Solvent (Ethanol) | ≤ 0.5% | ||
| Heavy Metals | |||
| Heavy Metals (as Pb) | ≤ 10 ppm | ||
| Microbiological & Endotoxin | |||
| Microbial Contamination | ≤ 100 CFU/g | ||
| Bacterial Endotoxins | < 0.05 IU/mg | ||
| Packaging & Storage | |||
| Packaging | 1 kg / 5 kg (upon request) | ||
| Storage Condition | Cool, dry, away from light | ||
| Shelf Life | 24 months | ||
| MW Grade | Range | Intrinsic Viscosity (m³/kg) | Recommended Application |
|---|---|---|---|
| Low MW | 10,000 – 400,000 Da | ~0.5 – 1.5 | Intra-articular injection, low-viscosity filler base |
| Medium MW | 400,000 – 1,500,000 Da | ~1.5 – 3.0 | Dermal fillers, viscosupplementation, sterile gel devices |
| High MW | 1,500,000 – 2,200,000 Da | ~3.0 – 4.5 | High-viscosity dermal filler matrices, long-duration joint therapy |
Bacterial endotoxin < 0.05 IU/mg — the most stringent level across all HA grades, meeting parenteral application requirements for both dermal fillers and intra-articular injections.
Zero animal tissue contamination risk. Fully traceable fermentation process from non-GMO glucose substrate — critical for parenteral product safety dossiers.
Protein content < 0.05% achieved in production — well below the 0.1% specification, minimizing immunogenic risk for injectable applications.
Full documentation set supporting CE marking (EU MDR), NMPA class III medical device registration, and FDA 510(k) pre-market notification as starting material.
Optimized molecular weight and solution viscosity for 0.22 μm sterile filtration — enabling aseptic fill-finish without the need for terminal sterilization.
Precise MW fractionation from 100,000 Da to 6,000,000 Da — custom target MW available for specific filler rheology or joint injection viscosity requirements.
Starting material for HA-based dermal filler products — crosslinked with BDDE to produce gel-phase fillers for facial volume restoration, lip augmentation, and wrinkle correction.
Viscosupplementation drug products for osteoarthritis treatment — injected directly into the joint space to restore synovial fluid lubrication and reduce pain.
Class II/III injectable medical device formulation — anti-adhesion barriers, surgical lubricants, and implantable device coatings requiring parenteral-grade HA.
Ultra-pure HA scaffold material for 3D cell culture, tissue engineering, and regenerative medicine research applications requiring defined purity profiles.
GRAS, fermentation-derived — for dietary supplements and functional foods.
Learn More →Ph.Eur. compliant — for oral pharmaceutical products and medical gels.
Learn More →Endotoxin-controlled (< 0.5 IU/mg) — for artificial tears and eye drops.
Learn More →Contact us for batch COA, endotoxin test reports, Ph.Eur. compliance documentation, and pricing for your required MW grade and application.