Crosslinked Sodium Hyaluronate
Source: Microbial fermentation method (Streptococcus equi subsp. zooepidemicus) prepared by crosslinking 1,4-butanediol diglycidyl ether (BDDE)
Content specification: Hyaluronic acid content: ≥ 95% (HPLC method)
Crosslinking degree range: 2-8% (detected by nuclear magnetic resonance hydrogen spectroscopy)
Molecular weight range: 1.0-2.4 × 10 ^ 6 Da (gel permeation chromatography)
Detection method: Purity detection: HPLC (C18 column, 0.1% TFA mobile phase)
Crosslinking degree determination: NMR detection of BDDE residue (<2 ppm)
Microbial limit: Complies with USP<61>standards
CAS NO: 9067-32-7
Active ingredient: β - D-glucuronic acid - (1 → 3) - β - D-N-acetylglucosamine disaccharide unit (crosslinked by epoxy crosslinking agent in a three-dimensional network)
Mesh size: Pharmaceutical grade: 80-120 mesh (injectable particles)
Cosmetic grade: 200-400 mesh (cream base)
Appearance: White to almost white fibrous powder;
The aqueous solution is transparent gel, pH 6.5-7.5 (1% aqueous solution);
Viscosity 500-2000 mPa · s (25 ℃, 1% concentration)
Product packaging: 1KG/aluminum foil bag; 25KG/cardboard drum
Product storage: Store in a dry and cool place, away from sunlight and high temperatures,
Refrigerate and store in the dark at 2-8 ℃ for liquid formulations;
Solid powder is stored under conditions of relative humidity ≤ 60% and temperature 15-25 ℃
Shelf life: unopened raw material powder: 24 months (microbial limit needs to be reviewed)
Preparation of injection solution: 6 months (requires the addition of 0.05% phenoxyethanol for preservation)
Products Description
Pharmaceutical-Grade Cross-linked Sodium Hyaluronate
by Xi'an Tihealth
Xi'an Tihealth Biotechnology Co., Ltd. is an advanced B2B manufacturer of premium Cross-linked Sodium Hyaluronate (Hyaluronic Acid/HA). Utilizing state-of-the-art BDDE (1,4-butanediol diglycidyl ether) in-situ covalent cross-linking technology, we engineer a robust 3D intermolecular network that significantly resists hyaluronidase degradation.
Compared to standard linear HA, our cross-linked hydrogel matrix delivers an exponentially longer in vivo retention time (up to 18 months), superior viscoelasticity (G' value 150-400 Pa), and controlled hydration swelling. Manufactured in a strict ISO 10993 and GMP-compliant facility, our product guarantees ultra-low BDDE residues (<2ppm) and endotoxin levels. It is the core API and raw material choice for high-end dermal fillers, orthopedic viscosupplements (osteoarthritis injections), and surgical anti-adhesion barriers worldwide.
Structural Characteristics & Performance
1. Robust 3D Cross-linked Network
By covalently cross-linking with BDDE (cross-linking degree 2-8%), robust intermolecular ether bonds are formed. This extends the in vitro anti-hyaluronidase hydrolysis resistance to 5-8 times that of uncrosslinked products, providing essential structural support for soft tissues.
2. Precise Molecular Weight Regulation
Adopting graded ultrafiltration technology, we achieve a highly controllable molecular weight distribution ranging from 1.0 to 2.4 × 10^6 Da. Medium MW (1.8 MDa) ensures smooth injection diffusion, while High MW (2.4 MDa) maximizes the spatial occupancy effect for deep tissue filling.
3. Absolute Security & Compliance
Strict ISO 10993 biocompatibility testing guarantees non-cytotoxicity. The residual BDDE is strictly controlled to <2 ppm via GC-MS, fully complying with FDA 21 CFR 184.1505. The molecular integrity remains intact even after 25kGy sterilization irradiation.
| Performance Indicator | Traditional Linear HA | Tihealth Cross-linked HA | Efficacy Improvement |
|---|---|---|---|
| Internal Retention Time | 2-3 Days | 6-18 Months | Extended by 200-300x |
| Dynamic Viscosity (1%, 25°C) | 50-200 mPa·s | 500-2000 mPa·s | Increased by 10x |
| Water Absorption Expansion | ~ 1000 Times | Regulated (300-800 Times) | Prevents post-injection edema |
| Reconstitution Time | > 5 Minutes | ≤ 30 Seconds | Supercritical CO2 processed |
Industrial & Clinical Applications
Medical Aesthetics (Dermal Fillers)
The foundational matrix for volume reconstruction injections (nasolabial folds, lip shaping). Maintains a single-injection structure for 8-12 months and acts as an enhancer for mesotherapy (water-light therapy).
Orthopedic Pharmaceuticals
Utilized in intra-articular injections for Osteoarthritis. The high MW network extends the joint half-life to 20 days, providing superior lubrication and inhibiting cartilage-degrading MMP-13 enzymes.
Surgical Medical Devices
Critical for ophthalmic viscosurgical devices (cataract surgery anterior chamber maintenance) and post-operative abdominal anti-adhesion barriers (with an adjustable dissolution time of 7-14 days).
Premium Skin Care & Topical Slow-Release
Functions as a long-lasting moisturizing matrix that binds up to 6L of water per gram. Acts as a controlled-release carrier for sensitive active ingredients (e.g., Vitamin C) for up to 72 hours.
Packing, Logistics & Lead Time
As a leading biotechnology supplier, Xi'an Tihealth provides robust international DDP/DDU logistics and flexible OEM/ODM formulation services.
| Order Quantity | < 25 kg | 25 - 100 kg | 100 - 1000 kg | > 1000 kg |
|---|---|---|---|---|
| Estimated Lead Time | 3 Days (Air Express) | 3 - 5 Days | 7 Days (Air/Sea) | 15 Days (Sea Freight) |
Formulator & Procurement FAQ
01. Is your Cross-Linked HA safe for injectable dermal fillers?
Yes. Our pharmaceutical-grade cross-linked HA is manufactured under strict GMP protocols. It passes comprehensive ISO 10993 biocompatibility testing and ensures BDDE residues are securely below 2ppm, meeting international standards for injectable soft tissue fillers.
02. Can you customize the Molecular Weight (MW) and Cross-linking degree?
Absolutely. Tihealth offers bespoke OEM services. We can adjust the molecular weight (from 1.0 to 2.4 MDa) and the BDDE cross-linking density (2-8%) to perfectly match your target application-whether it's high-viscosity bone joint injections or smooth-flowing aesthetic water-light therapies.
03. What is the difference between Linear HA and Cross-Linked HA?
Natural linear HA degrades within 1-3 days in the body due to hyaluronidase enzymes. Cross-linked HA utilizes an ether bond network to resist this degradation, drastically extending its physical support and moisturizing capabilities to 6-18 months.
04. Do you provide samples and regulatory documentation?
Yes, we provide R&D samples for lab formulation testing. Every bulk shipment is accompanied by a full Certificate of Analysis (COA), GC-MS test reports for BDDE residue, and necessary documentation to assist with your local medical device or drug registrations.
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