Sodium Hyaluronate Powder Injection Grade M.W 1,600-2,500 kDa — EP/DMF/GMP Certified Supplier
High molecular weight injection-grade sodium hyaluronate (1,600-2,500 kDa) — EP/DMF/GMP certified for parenteral pharmaceutical products and implantable medical devices. Bacterial endotoxin <0.05 EU/mg. Exceptional viscoelasticity for intra-articular viscosupplementation (knee osteoarthritis), ophthalmic viscosurgical devices (OVDs), and HA-based dermal filler raw material. High MW provides the rheological characteristics — high zero-shear viscosity, pronounced shear-thinning behavior, and strong viscoelastic modulus (G') — that restore the depleted mechanical properties of osteoarthritic synovial fluid. Full DMF Type IV documentation for ANDA/NDA/MAA regulatory filing. Injection-grade HA manufacturer and bulk supplier — UPOR Biotech.
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Sodium Hyaluronate Powder Injection Grade (INCI: Sodium Hyaluronate, CAS 9067-32-7, M.W 1,600-2,500 kDa) is a pharmaceutical-grade HA manufactured specifically for parenteral (injectable) pharmaceutical products, implantable medical devices, and viscosupplementation. At 1.6-2.5 million Daltons, this high MW grade delivers the exceptional viscoelastic, space-filling, and lubricating properties essential for injectable HA products. The high molecular weight provides the rheological characteristics critical for clinical performance: high zero-shear viscosity (η₀) for joint space maintenance between loading cycles, pronounced shear-thinning behavior for injectability through fine-gauge needles (21-25G), and strong viscoelastic modulus (storage modulus G' > loss modulus G'' at physiological frequencies) for effective shock absorption during ambulation. These properties are essential for intra-articular viscosupplementation in knee osteoarthritis, where the injected HA must restore the depleted viscoelasticity and lubricating properties of osteoarthritic synovial fluid — which has reduced HA concentration (1-2 mg/mL vs 2-4 mg/mL in healthy joints) and degraded MW (500-1,500 kDa vs 2,000-6,000 kDa in healthy). Manufactured under full EP (monograph 1472), DMF Type IV, and c-GMP (ICH Q7, 21 CFR 210/211) with bacterial endotoxin control <0.05 EU/mg (LAL kinetic chromogenic method) — the most stringent parenteral limit, 10× stricter than ophthalmic grade (<0.5 EU/mg) and 1,000× stricter than cosmetic grade (<50 EU/mg). This endotoxin control is critical because injectable products bypass the body's natural barriers (skin, mucous membranes, GI tract) and enter directly into the joint cavity, dermis, or anterior chamber of the eye — even sub-clinical endotoxin levels can trigger TLR4/MD-2-mediated inflammatory cascades (IL-1β, TNF-α, IL-6), local pain and swelling, and pseudoseptic reactions in parenteral products.
As a specialized injection-grade HA manufacturer and bulk supplier, UPOR Biotech provides this raw material powder — not the finished injectable product — to pharmaceutical companies, medical device manufacturers, and contract manufacturing organizations (CMOs) who perform downstream formulation (dissolution in PBS at 0.5-2.0% w/v), aseptic filling into pre-filled syringes or vials, and terminal sterilization (autoclave 121°C 15-20 min validated per ISO 17665, or aseptic filtration 0.22 μm for lower MW formulations). DMF Type IV documentation provides complete CMC data — manufacturing process, critical process parameters (CPPs) and critical quality attributes (CQAs), specifications, batch analysis (minimum 3 consecutive lots), stability data, and container closure information — to support your ANDA (USA), NDA, MAA (EU), or 510(k) (medical device) filing. All purchasers must hold appropriate pharmaceutical manufacturing or medical device licenses.
Pharmaceutical-Grade HA for Parenteral Use — DMF-Supported Regulatory Filing
Injectable HA products — intra-articular viscosupplements, dermal fillers, and ophthalmic surgical devices — require raw materials of the highest pharmaceutical quality, purity, and regulatory documentation. UPOR Biotech's EP/DMF/GMP-certified injection-grade HA provides: (1) Full EP monograph 1472 compliance with bacterial endotoxin <0.05 EU/mg — the parenteral-grade limit, 10× stricter than ophthalmic and 1,000× stricter than cosmetic. (2) DMF Type IV providing complete CMC data — manufacturing process, CPPs/CQAs, batch analysis, and stability — for ANDA/NDA/MAA/510(k) cross-referencing. (3) c-GMP (ICH Q7, 21 CFR 210/211) manufacturing with ISO 9001:2015 quality management, FDA facility registration, and complete lot traceability. (4) High MW (1,600-2,500 kDa) delivering the viscoelastic, space-filling, and lubricating properties essential for viscosupplementation, OVDs, and dermal filler base HA.
Technical Specifications
| Property | Specification |
|---|---|
| Product Name | Sodium Hyaluronate Powder — Injection Grade (High MW) |
| Grade | Injection Grade / Pharmaceutical Grade — for parenteral products and implantable medical devices |
| CAS Number | 9067-32-7 (Sodium Hyaluronate) |
| Molecular Weight Range | 1,600 – 2,500 kDa (High MW — GPC-MALLS verified) |
| Key Advantage | Parenteral-grade HA: high viscoelasticity for viscosupplementation and OVDs. Endotoxin <0.05 EU/mg. Full DMF Type IV for ANDA/NDA/MAA/510(k) filing. |
| Appearance | White to off-white powder or fibrous aggregate; hygroscopic |
| Assay — Sodium Hyaluronate (Dry Basis) | 95.0 – 105.0% (EP monograph 1472) |
| Glucuronic Acid Content | 42.0 – 48.0% (carbazole method) |
| Intrinsic Viscosity | 2.5 – 4.5 m³/kg (EP monograph 1472 — correlates to MW and viscoelastic performance) |
| Kinematic Viscosity (0.5% w/v, 25°C) | 40 – 100 mm²/s |
| pH (0.5% w/v Solution, 25°C) | 5.0 – 7.5 |
| Solution Clarity (T550nm, 0.5% w/v) | ≥99.0% (EP parenteral requirement) |
| Absorbance (A280nm, 0.5% w/v) | ≤0.25 |
| Bacterial Endotoxins — Critical Quality Attribute | <0.05 EU/mg (LAL kinetic chromogenic — parenteral limit; 10× stricter than ophthalmic <0.5 EU/mg; 1,000× stricter than cosmetic <50 EU/mg) |
| Sterility | Meets USP <71> sterility requirements (raw material — pre-terminal sterilization by finished product manufacturer) |
| Protein Content | ≤0.1% (Lowry/Bradford — minimizes immunogenic risk upon injection) |
| Nucleic Acid | ≤0.5% (A260nm) |
| Loss on Drying | ≤10.0% (105°C, 2h) |
| Residue on Ignition | ≤20.0% |
| Heavy Metals (Total) | ≤10 ppm (as Pb) |
| Elemental Impurities | Pb ≤2 ppm; As ≤1 ppm; Hg ≤1 ppm; Cd ≤1 ppm (ICH Q3D) |
| Microbial Limits | TAMC ≤100 CFU/g; TYMC ≤50 CFU/g (USP <61>); P. aeruginosa, S. aureus — Negative (USP <62>) |
| Solubility | Soluble in water (requires gentle stirring 2-4h for 1% w/v at 25°C; avoid high-shear mixing to prevent MW degradation) |
| Recommended Concentration — Viscosupplementation | 0.5 – 1.0% w/v (5-10 mg/mL in PBS pH 7.4, osmolality 280-320 mOsm/kg) |
| Recommended Concentration — OVDs | 1.0 – 2.3% w/v (10-23 mg/mL for anterior chamber maintenance during cataract surgery) |
| Sterilization Compatibility | Autoclavable (121°C, 15-20 min — validate post-sterilization MW and viscosity); aseptic filtration (0.22 μm) for lower-concentration formulations |
| Certifications | EP Monograph 1472, DMF Type IV, GMP ICH Q7 / 21 CFR 210/211, ISO 9001:2015, FDA Facility Registration, HALAL, KOSHER, BSE/TSE-Free |
| Packaging | 100 g / 1 kg / 5 kg pharmaceutical-grade HDPE containers with desiccant; custom packaging available |
| Storage | 2-8°C recommended; tightly sealed; protect from moisture and light |
| Shelf Life | 36 months under recommended storage; MW, viscosity, and endotoxin stability verified at 3/6/12/24/36 months |
Key Benefits — HA Injection Grade (High MW)
EP/DMF/GMP Certified — Full Parenteral Regulatory Compliance
Meets EP monograph 1472, DMF Type IV filing support, c-GMP (ICH Q7, 21 CFR 210/211) manufacturing. Complete CMC documentation — CPPs, CQAs, batch analysis, stability — enables ANDA/NDA/MAA/510(k) regulatory submissions for injectable HA finished products.
EP/DMF/GMPExceptional Viscoelasticity — Synovial Fluid Restoration
High MW HA (1,600-2,500 kDa) provides high zero-shear viscosity, strong G' > G'' at physiological frequencies, and pronounced shear-thinning behavior — restoring the depleted rheological properties of osteoarthritic synovial fluid for effective viscosupplementation, shock absorption, and joint lubrication.
High ViscoelasticityUltra-Low Endotoxin — <0.05 EU/mg Parenteral-Grade
Bacterial endotoxin <0.05 EU/mg — 10× stricter than ophthalmic (<0.5 EU/mg) and 1,000× stricter than cosmetic (<50 EU/mg). Critical for injectable products that bypass natural barriers — minimizes TLR4-mediated inflammatory risk in intra-articular, intradermal, and intraocular applications.
Ultra-Low EndotoxinHigh Purity — Minimal Immunogenic Risk
Protein ≤0.1%, nucleic acid ≤0.5%, heavy metals ≤10 ppm. The high purity profile, combined with EP-compliant manufacturing and endotoxin control, ensures the HA raw material meets the quality expectations for implantable and injectable medical products with minimal immunogenic potential.
High PurityApplications
Intra-Articular Viscosupplementation — Knee Osteoarthritis
High MW HA at 0.5-1.0% w/v for knee OA injections (1-3 per course). Restores synovial fluid viscoelasticity, reduces pain (WOMAC scores), and improves joint function. DMF-supported for ANDA/510(k) viscosupplement filings.
HA Dermal Filler Raw Material — Crosslinking Base HA
Base high MW HA for BDDE crosslinking into injectable dermal fillers. The high MW provides optimal starting viscosity and chain entanglement for crosslinking efficiency. Supplied as raw material powder for filler manufacturers.
Ophthalmic Viscosurgical Devices (OVDs) — Cataract Surgery
Space-maintaining viscoelastic (1.0-2.3% w/v) for anterior segment surgery. Protects corneal endothelium during phacoemulsification, maintains anterior chamber depth, and facilitates IOL implantation. Parenteral-grade endotoxin control.
Post-Surgical Adhesion Prevention — Anti-Adhesion Gels
HA-based anti-adhesion gels and films for abdominal/pelvic surgery. High MW HA provides the viscoelastic barrier that separates injured tissue surfaces during the critical 3-5 day postoperative adhesion formation window.
Parenteral Drug Delivery — Sustained-Release HA Depots
High MW HA as a viscoelastic hydrogel depot for injectable sustained-release formulations. The entangled polymer network provides steric hindrance and reduced convective transport for extended drug release over days to weeks.
ANDA/NDA/MAA-Regulated Injectable Products — DMF-Supported
DMF Type IV-supported raw material for regulated injectable HA products. Complete CMC documentation, batch analysis (3 lots), and stability data for FDA, EMA, PMDA, TGA, and global regulatory submissions.
Molecular Weight Comparison — HA Grades
| Grade | Molecular Weight / Structure | Primary Function | Skin / Tissue Penetration |
|---|---|---|---|
| Injection Grade High MW (this product) | 1,600-2,500 kDa | Viscosupplementation, viscoelasticity, space-filling, lubrication — injectable pharmaceuticals and implantable devices. Endotoxin <0.05 EU/mg. | Intra-articular space; anterior chamber; intradermal |
| Injection Grade Medium MW | 800-1,500 kDa | Injectable products requiring moderate viscoelasticity; ophthalmic solutions with easier handling | Intra-articular; ocular tissues |
| Injection Grade Low MW | 200-800 kDa | Ophthalmic irrigating solutions; injectable drug delivery; lower viscosity parenteral formulations | Ocular tissues; systemic |
| Cosmetic Grade High MW | 1,500-2,000 kDa | Film-forming, thickening, surface hydration — topical use | Stratum corneum |
| Cosmetic Grade Medium MW | 1,000-1,500 kDa | Moisturizing, moderate thickening — topical use | Upper epidermis |
| Cosmetic Grade Low MW | 400-1,000 kDa | Deep hydration, anti-wrinkle — topical use | Deeper epidermis |
| Cosmetic Grade Extra Low MW | 100-400 kDa | Deep skin penetration, firming — topical use | Epidermis-dermis junction |
| Oligo HA | 7-10 kDa | Cellular signaling, wound healing | Deep dermis |
| Cationic HA | >1,000 kDa + cationic charge | Electrostatic adhesion, rinse-resistant moisturization | Surface-adherent film |
| Acetylated HA (AcHA) | ~20-100 kDa + acetyl groups | Amphiphilic, 2× moisture retention, barrier repair | Stratum corneum |
| Crosspolymer HA | Cross-linked 3D network | Long-lasting hydration, anti-pollution | Surface film + sustained release |
| HA Low pH (<50 kDa) | <50 kDa | Acidic delivery, exfoliation-compatible hydration | Epidermis-Dermis |
| Zinc Hyaluronate | 10-50 kDa (hydrolyzed) | Anti-acne, sebum regulation, wound healing | Epidermis-Dermis |
Frequently Asked Questions
Viscosupplementation is the intra-articular injection of HA into osteoarthritic joints to restore the depleted viscoelasticity and lubricating properties of synovial fluid. In osteoarthritis, synovial fluid HA concentration drops from 2-4 mg/mL to 1-2 mg/mL and MW degrades from 2,000-6,000 kDa to 500-1,500 kDa — losing its ability to protect articular cartilage. High MW HA (1,600-2,500 kDa) is preferred because it most closely mimics the rheological properties of healthy synovial fluid: high zero-shear viscosity for joint space maintenance between loading cycles, strong viscoelastic modulus (G' > G'') at physiological frequencies for shock absorption during ambulation, and pronounced shear-thinning for injectability through 21-25G needles. The high MW results in longer intra-articular residence time (days to weeks vs hours for low MW) and superior clinical outcomes — WOMAC pain reduction, improved joint function, and delayed need for total knee arthroplasty. This raw material powder is supplied to finished product manufacturers who formulate, fill, and terminally sterilize the final injectable viscosupplement product.
Our DMF Type IV provides complete CMC data for your ANDA/NDA/MAA/510(k) regulatory submission: manufacturing process description and flow diagram, facilities and equipment information, raw material specifications and supplier qualification, critical process parameters (CPPs) and critical quality attributes (CQAs), in-process controls, analytical method validation, batch analysis data (minimum 3 consecutive commercial-scale lots), stability data (36-month real-time + 6-month accelerated per ICH Q1A), container closure system description, and DMF Letter of Authorization for cross-referencing. Additionally, each batch ships with COA (full EP monograph 1472 compliance), MSDS, TSE/BSE statement (fermentation-derived — animal-free), endotoxin certificate (<0.05 EU/mg LAL), and complete lot traceability records.
The endotoxin limit is <0.05 EU/mg for injection grade — the most stringent HA quality level. For comparison: injection grade <0.05 EU/mg (lowest — parenteral/implant), ophthalmic grade <0.5 EU/mg (10× higher), cosmetic grade <50 EU/mg (1,000× higher). This is critical because injectable products bypass the body's natural barriers (skin, mucous membranes, GI tract) and enter directly into the joint cavity (intra-articular), dermis (intradermal filler), or anterior chamber of the eye (intraocular OVD). Even sub-clinical endotoxin levels (<0.5 EU/mg) can trigger TLR4/MD-2/CD14-mediated innate immune activation → NF-κB → pro-inflammatory cytokine cascade (IL-1β, TNF-α, IL-6) → local pain, swelling, joint effusion, and pseudoseptic reactions. Our injection-grade HA is controlled to <0.05 EU/mg by LAL kinetic chromogenic method (USP <85>) with every batch verified — meeting the strictest global pharmacopoeia requirements (EP, USP, JP) for parenteral-grade raw materials.
No. This is the raw material powder — not a finished injectable product. The injection grade designation means the raw material quality (purity, endotoxin <0.05 EU/mg, sterility, EP compliance) meets the stringent requirements for parenteral product manufacturing. The finished product manufacturer performs the following downstream steps: (1) Dissolution — hydrating the powder in phosphate-buffered saline (PBS pH 7.4) at 0.5-2.0% w/v with gentle stirring (2-4h at 25°C; avoid vortex/shear degradation of high MW HA); (2) Osmolality adjustment — to 280-320 mOsm/kg (isotonic) with NaCl if needed; (3) Aseptic filling — into pre-filled glass syringes (1-3 mL BD Hypak or equivalent) under ISO 5 (Class 100) laminar flow; (4) Terminal sterilization — moist heat (autoclave 121°C, 15-20 min, validated per ISO 17665 with post-sterilization MW and viscosity verification). The finished injectable product must then undergo final QC — sterility (USP <71>), endotoxin (<0.5 EU/device — finished product limit), particulate matter (USP <788> for injection), extrusion force, and package integrity.
ISO 9001:2015, c-GMP (ICH Q7 and 21 CFR 210/211), FDA registered drug establishment, HALAL, KOSHER. Full EP monograph 1472 (Sodium Hyaluronate) compliance verified for every batch. DMF Type IV available with Letter of Authorization. Bacterial endotoxin <0.05 EU/mg (parenteral limit). Additional applicable standards depend on finished product classification: ISO 10993 (biocompatibility — cytotoxicity, sensitization, irritation, systemic toxicity, implantation) for medical devices; ISO 13485 (QMS for medical devices) if supplied as device component; ICH Q1A-Q1F stability testing; USP <71> sterility, USP <85> endotoxin, USP <788> particulate matter for the finished injectable. All documents in English.