Typical parameters for Crosslinked Sodium Hyaluronate (CSHA251217). Actual COA provided per batch.
| Test Item | Result / Specification |
|---|---|
| Physical & Chemical | |
| Appearance | White or almost white powder, granules or fibrous material |
| Identification | Conforms to IR spectrum; Positive sodium salt reaction |
| Clarity (A₆₀₀ₙₘ) | ≤ 0.01 |
| pH (0.5% solution) | 5.0 – 8.5 |
| Average Molecular Weight | > 3.0 × 10⁶ Da |
| Loss on Drying | ≤ 15.0% |
| Assay (Sodium Hyaluronate content) | ≥ 90% |
| Residual Solvent BDDE | ≤ 50 μg/g |
| Heavy Metals (as Pb) | ≤ 10 ppm |
| Microbiological (Injectable Grade) | |
| Total Aerobic Count | ≤ 5 CFU/g |
| Molds & Yeasts | ≤ 1 CFU/g |
| Bacterial Endotoxins | < 0.05 IU/mg |
| Thermotolerant Coliform Bacteria | Negative |
| Staphylococcus aureus | Negative |
| Pseudomonas aeruginosa | Negative |
| Storage & Shelf Life | |
| Shelf Life | 24 months |
| Storage | Cool and dry place |
Uses 1,4-butanediol diglycidyl ether (BDDE) to form covalent crosslinks between HA polymer chains, creating a three-dimensional gel network that significantly prolongs in-vivo degradation time
Residual BDDE ≤ 50 μg/g — well below industry safety thresholds, a critical quality control parameter for injectable product safety
Bacterial endotoxin < 0.05 IU/mg — equivalent to injectable-grade HA raw material standard, ensuring injection safety of finished filler products
Available in both monophasic (homogeneous gel) and biphasic (particle-in-gel) formats to accommodate different injection depths and rheological requirements
Base HA molecular weight > 3.0 × 10⁶ Da — high starting MW ensures the crosslinked gel exhibits excellent viscoelasticity and structural support
Total aerobic count ≤ 5 CFU/g and molds ≤ 1 CFU/g — near-sterile microbial profile providing an extremely low bioburden starting point for aseptic fill-finish manufacturing
The core raw material for HA-based dermal fillers — crosslinked HA gel is aseptically filled for use in facial volume restoration, lip augmentation, and wrinkle correction
Viscosupplementation therapy for osteoarthritis — crosslinked HA persists significantly longer in the joint space than linear HA, providing more durable lubrication and cushioning
CE-marked Class III medical device starting material requiring complete documentation on crosslinking degree, residual BDDE, endotoxin, and rheological properties
As a scaffold material, crosslinked HA hydrogels provide a three-dimensional cell culture matrix for tissue engineering and regenerative medicine research
Contact our technical team for specialized crosslinked HA solutions, including custom crosslinking density and formulation support.