Product Name：  Ornithine-Crosslinked Sodium Hyaluronate Powder  

INCI Name: Sodium Hyaluronate Crosspolymer  

Description

Ornithine-Crosslinked Sodium Hyaluronate is a chemically modified hyaluronic acid (HA) derivative engineered through covalent crosslinking with ornithine, a non-proteinogenic amino acid. This modification enhances the polymer’s viscoelasticity, biodegradation resistance, and longevity in vivo compared to linear HA. The product is supplied as a sterile, lyophilized powder for reconstitution with appropriate solvents.  

 Key Features

 High Elasticity & Cohesivity: Optimized for tissue support and volumization.  

 Biocompatible & Bioresorbable: Degrades naturally via hydrolysis and enzymatic action.  

Customizable Viscosity: Rheological properties adjustable via crosslinking density.  

 Sterile & Pyrogen-Free: Meets ISO 13485 and USP standards for medical devices.  

 Intended Use  

 Dermal Fillers: For mid-to-deep dermal implantation to correct moderate-to-severe wrinkles, folds, and volume loss (e.g., nasolabial folds, cheeks).  

 Joint Lubrication: Intra-articular injection for osteoarthritis management (pending regulatory approval).  

Wound Healing: Topical or injectable formulations for tissue regeneration.  

 Composition  

| Component                | Specification                      |  

|--------------------------|----------------------------------------                   |  

| Sodium Hyaluronate       | Crosslinked with ornithine [XX%]       |  

| Residual Ornithine       | ≤ [X] ppm (per batch analysis)         |  

| Moisture Content         | ≤ 2.0% (Karl Fischer method)         |  

| Endotoxin Level          | < 0.05 EU/mg (LAL test)                |  

Reconstitution Guidelines  

1. Solvent: Use sterile phosphate-buffered saline (PBS) or lidocaine HCl (0.3–1.0%) for clinical applications.  

2. Ratio: 1:1 to 1:2 (powder:solvent) depending on desired viscosity (e.g., 20 mg/mL for high cohesivity).  

3. Mixing: Gently swirl (avoid vortexing) at room temperature for 5–10 minutes until fully dissolved.  

Storage & Handling  

- Storage: 2–8°C in original sealed vial. Protect from light and moisture.  

- Shelf Life: 24 months unopened. Use immediately after reconstitution (stable for ≤24 hours at 4°C).  

- DO NOT FREEZE reconstituted product.  

Safety & Precautions

- Contraindications: Hypersensitivity to hyaluronic acid, gram-positive bacterial protein allergy, or active infection at injection site.  

Adverse Reactions: Temporary erythema, swelling, or tenderness (resolve within 7–14 days).  

Post-Treatment Care: Avoid UV exposure, excessive heat, or strenuous activity for 48 hours.  

Regulatory Status

- CE Marked under Class III Medical Device (EU).  

- For investigational use in the USA (not FDA-approved).  

 Packaging  

- Form: Lyophilized powder in sterile glass vials.  

- Sizes: 10 mg, 20 mg, 50 mg per vial.  

This product is intended for use by licensed healthcare professionals. Always follow local regulations and clinical guidelines.*

Let me know if you need adjustments for specific regulatory requirements or application details!