Sodium Hyaluronate Powder Eye Drops Grade M.W 1,600-2,500 kDa — EP/DMF/GMP Certified Supplier
High molecular weight ophthalmic-grade sodium hyaluronate (1,600-2,500 kDa) — EP/DMF/GMP certified with bacterial endotoxin <0.5 EU/mg. Exceptional viscoelasticity for prolonged corneal residence time, superior tear film stabilization, and shear-thinning rheology that maximizes both patient comfort (low viscosity during blinking) and therapeutic efficacy (high viscosity between blinks). The gold-standard HA for preservative-free dry eye treatment, contact lens solutions, and ophthalmic viscosurgical devices (OVDs). Complete DMF documentation for ANDA/NDA/MAA regulatory filing. Eye drops grade HA manufacturer and bulk supplier — UPOR Biotech.
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Sodium Hyaluronate Powder Eye Drops Grade (INCI: Sodium Hyaluronate, CAS 9067-32-7, M.W 1,600-2,500 kDa) is a premium ophthalmic-grade hyaluronic acid sodium salt specifically manufactured for ophthalmic pharmaceutical and medical device applications. At 1.6-2.5 million Daltons (1,600-2,500 kDa), this high molecular weight grade delivers the exceptional viscoelastic, mucoadhesive, and water-retention properties that are critical for ophthalmic formulations. The long HA polymer chains form an entangled viscoelastic network that resists rapid nasolacrimal drainage and blinking clearance — the two primary mechanisms of ocular surface drug loss. Clinical tear film break-up time (TBUT) studies demonstrate that high MW HA (≥1,500 kDa) provides 2-3× longer corneal residence time compared to low MW HA (<500 kDa), directly translating to less frequent dosing, better patient compliance, and superior clinical outcomes in dry eye syndrome management. The ideal shear-thinning rheology of high MW HA at ophthalmic concentrations (0.1-0.4% w/v) delivers the optimal patient experience: low viscosity during the high-shear blink phase (thin, comfortable, no visual blurring), transitioning to high viscosity at rest between blinks (thick, stable lubricating film on the ocular surface). Manufactured under full EP (European Pharmacopoeia monograph 1472 for Sodium Hyaluronate), DMF (Drug Master File), and GMP (ICH Q7) conditions, this grade meets the most stringent quality requirements for ophthalmic pharmaceutical products and medical devices — including bacterial endotoxin control <0.5 EU/mg (LAL kinetic chromogenic method), solution clarity T550nm ≥99.0%, and absorbance A280nm ≤0.25, all verified in every batch COA. The DMF documentation supports your finished product ANDA (USA), NDA, MAA (EU), or 510(k)/CE marking regulatory filing by providing complete CMC (Chemistry, Manufacturing, and Controls) data.
As a specialized ophthalmic-grade HA manufacturer and bulk supplier, UPOR Biotech provides EP/DMF/GMP-certified sodium hyaluronate for B2B ophthalmic pharmaceutical companies, contract manufacturers, and medical device developers worldwide. High MW HA's position as the gold-standard viscoelastic polymer for ocular surface applications makes it the essential raw material for preservative-free artificial tears, contact lens rewetting drops, and ophthalmic viscosurgical devices (OVDs) used in cataract, glaucoma, and corneal transplant surgery. OEM formulations and DMF Type IV support available. Free sample available for qualified B2B buyers.
High MW HA for Ophthalmology — Prolonged Corneal Residence Time
High MW HA (1,600-2,500 kDa) forms long, entangled polymer chains that create a stable, mucoadhesive viscoelastic film on the ocular surface. This film resists nasolacrimal drainage (the constant flow of tears from the ocular surface into the nasal cavity via the lacrimal duct — the primary clearance mechanism, removing ~90% of an instilled drop within 2 minutes) and blinking clearance. Clinical studies demonstrate 2-3× longer corneal residence time vs low MW HA (<500 kDa). For dry eye formulations, this translates to less frequent dosing (BID vs QID), better patient compliance, and superior clinical outcomes. The shear-thinning rheology maximizes both comfort (low viscosity during blinking) and protection (high viscosity between blinks). EP/DMF/GMP certification with endotoxin <0.5 EU/mg ensures your ophthalmic product meets FDA, EMA, and global regulatory standards.
Technical Specifications
| Property | Specification |
|---|---|
| Product Name | Sodium Hyaluronate Powder — Eye Drops Grade / Ophthalmic Grade |
| Grade | Eye Drops Grade / Medical Grade — EP/DMF/GMP Certified |
| CAS Number | 9067-32-7 (Sodium Hyaluronate) |
| Molecular Weight Range | 1,600 – 2,500 kDa (High MW — GPC-MALLS verified) |
| Key Advantage | 2-3× prolonged corneal residence time vs low MW HA. Shear-thinning rheology for optimal comfort and protection. EP/DMF/GMP certified with endotoxin <0.5 EU/mg. |
| Appearance | White to off-white powder or fibrous aggregate; hygroscopic |
| Assay — Sodium Hyaluronate (Dry Basis) | 95.0 – 105.0% (EP monograph 1472 — carbazole assay or CPC titration) |
| Glucuronic Acid Content | 42.0 – 48.0% (carbazole method) |
| Intrinsic Viscosity | 2.5 – 4.5 m³/kg (EP monograph 1472 — Ubbelohde capillary viscometer) |
| 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 ophthalmic requirement — absence of insoluble particulate) |
| Absorbance (A280nm, 0.5% w/v) | ≤0.25 (low protein/nucleic acid contamination — EP requirement) |
| Bacterial Endotoxins — Critical Quality Attribute | <0.5 EU/mg (LAL kinetic chromogenic method — EP ophthalmic monograph limit; 100× stricter than cosmetic grade <50 EU/mg) |
| Sterility | Sterile or controlled microbial limits per EP ophthalmic monograph (USP <71>) |
| Protein Content | ≤0.1% (Lowry/Bradford) |
| Nucleic Acid | ≤0.5% (UV A260/A280 ratio) |
| Loss on Drying | ≤10.0% (105°C, 2h) |
| Residue on Ignition | ≤20.0% |
| Heavy Metals (Total) | ≤10 ppm (as Pb) |
| Iron (Fe) | ≤80 ppm (EP ophthalmic monograph — iron catalyzes HA oxidative degradation) |
| 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> — critical ophthalmic pathogens) |
| Solubility | Soluble in water (1% w/v requires gentle stirring 2-4 hours at room temperature; avoid vortex-induced shear degradation of high MW HA) |
| Recommended Concentration — Eye Drops | 0.1 – 0.4% w/v (0.3-0.4% for moderate-to-severe dry eye; 0.1-0.2% for mild dry eye and contact lens applications) |
| Recommended Concentration — OVDs | 1.0 – 2.3% w/v (ophthalmic viscosurgical devices — higher concentration for space maintenance during anterior segment surgery) |
| Certifications | EP Monograph 1472 (Sodium Hyaluronate), DMF Type IV, GMP ICH Q7, ISO 9001:2015, FDA Facility Registration, HALAL, KOSHER, BSE/TSE-Free |
| Sterilization Compatibility | Autoclavable (121°C, 15-20 min — validated for MW and viscosity stability); Sterile filtration (0.22 μm) for preservative-free unit-dose |
| Packaging | 100 g / 1 kg / 5 kg / 25 kg pharmaceutical-grade HDPE containers with desiccant; custom packaging available |
| Storage | 2-8°C recommended; tightly sealed in original container; protect from moisture (hygroscopic) and light |
| Shelf Life | 36 months from date of manufacture under recommended storage (unopened, cool and dry); MW, viscosity, and endotoxin stability verified at 3/6/12/24/36 months |
Key Benefits — HA Eye Drops Grade
2-3× Prolonged Corneal Residence Time vs Low MW HA
High MW HA chains (1.6-2.5 MDa) form an entangled, mucoadhesive viscoelastic network that resists nasolacrimal drainage (~90% of drops cleared in <2 min) and blinking clearance. Clinical TBUT studies confirm significantly longer ocular surface retention — sustained lubrication with less frequent dosing.
Extended RetentionEP/DMF/GMP Certified — Endotoxin <0.5 EU/mg
Full EP monograph 1472 compliance, DMF Type IV filing support, and GMP (ICH Q7) manufacturing. Bacterial endotoxin <0.5 EU/mg — 100× stricter than cosmetic grade (<50 EU/mg). Meets FDA, EMA, and global ophthalmic product regulatory requirements for ANDA/NDA/MAA/510(k) filing.
Pharma CertifiedSuperior Tear Film Stabilization — Dual-Action Dry Eye Management
The viscoelastic HA film interacts with and stabilizes the tear film lipid layer, reducing aqueous tear evaporation and improving TBUT. Delivers both immediate lubrication upon instillation and sustained protection after drainage — HA mucoadhesion maintains a residual polymer layer even after bulk fluid clearance.
Dual-ActionShear-Thinning Viscoelasticity — Comfort and Protection
At 0.1-0.4% w/v, high MW HA exhibits ideal shear-thinning behavior: low viscosity during blinking shear (thin, comfortable, no blurring, no sticky sensation), high viscosity at rest between blinks (stable lubricating film). This rheological profile simultaneously maximizes patient comfort and therapeutic efficacy.
Optimal RheologyApplications
Dry Eye Syndrome — Artificial Tears and Lubricating Eye Drops
Use at 0.1-0.4% w/v for superior and long-lasting symptomatic relief. High MW HA provides sustained corneal lubrication and tear film stabilization. Suitable for preservative-free unit-dose and multi-dose formulations.
Ophthalmic Viscosurgical Devices (OVDs) — Cataract and Corneal Surgery
Space-maintaining viscoelastic for anterior segment surgery. High MW HA (1.0-2.3% w/v) protects corneal endothelium during phacoemulsification, maintains anterior chamber depth, and facilitates IOL implantation.
Contact Lens Solutions — Rewetting and Multipurpose
HA adsorbs onto contact lens surfaces providing natural, biocompatible wetting and extended comfort. Compatible with soft (silicone hydrogel and hydrogel) and rigid gas permeable (RGP) lens materials.
Post-Surgical Ophthalmic Care — Recovery Formulations
Post-cataract, post-LASIK, post-PRK, and post-corneal transplant recovery formulations. HA promotes corneal epithelial wound healing via CD44 receptor-mediated migration and provides lubricated blinking during recovery.
Preservative-Free Unit-Dose Eye Drops — Single-Use
Ideal for single-use, preservative-free dry eye formulations. High MW HA provides prolonged corneal residence — critical for unit-dose where patients expect full-day relief from one vial. Compatible with blow-fill-seal (BFS) aseptic manufacturing.
Ophthalmic Drug Delivery — Viscosity-Enhancing Vehicle
Viscosity-enhancing vehicle for ophthalmic drug formulations (antibiotics, anti-inflammatory, anti-glaucoma) requiring extended corneal contact time for improved drug bioavailability and reduced systemic absorption via nasolacrimal drainage.
Molecular Weight Comparison — HA Grades
| Grade | Molecular Weight / Structure | Primary Function | Skin / Tissue Penetration |
|---|---|---|---|
| High MW | 1,500-2,000 kDa | Film-forming, thickening, surface hydration | Surface only (stratum corneum) |
| Medium MW | 1,000-1,500 kDa | Moisturizing, moderate thickening | Upper epidermis |
| HA Eye Drops Grade High MW (this product) | 1,600-2,500 kDa | Ophthalmic viscoelastic, prolonged corneal residence, tear film stabilization, dry eye treatment, OVDs | Ocular surface (prolonged retention — 2-3× vs low MW) |
| Low MW | 400-1,000 kDa | Deep hydration, anti-wrinkle | Deeper epidermis |
| Extra Low MW | 100-400 kDa | Deep skin penetration, firming | Epidermis-dermis junction |
| Super Low MW | 20-50 kDa | Transdermal delivery, plumping | Dermis |
| 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 (23-29%) | Amphiphilic, 2× moisture retention, barrier repair, antioxidant | Stratum corneum |
| Crosspolymer HA | Cross-linked 3D network | Long-lasting hydration, anti-pollution, 5× moisture retention | 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
High MW HA provides 2-3× longer corneal residence time compared to lower MW grades. The long polymer chains (1.6-2.5 MDa) form an entangled viscoelastic network that resists the two primary ocular surface clearance mechanisms: (1) nasolacrimal drainage — the constant flow of tears from the ocular surface into the nasal cavity via the lacrimal puncta and canaliculi removes ~90% of an instilled drop volume within 2 minutes; high MW HA's mucoadhesive properties and high extensional viscosity slow this drainage. (2) Blinking clearance — the shear force of the eyelid during a blink (velocity ~10 cm/s) mechanically displaces the tear film; high MW HA's viscoelastic network stores elastic energy and recoils, re-forming the protective film between blinks. Additionally, high MW HA exhibits ideal shear-thinning rheology — under the high shear of a blink (shear rate ~10,000 s⁻¹), viscosity drops dramatically for comfort (no blurring, no sticky sensation); at rest between blinks (shear rate ~0.1 s⁻¹), viscosity recovers to provide a stable lubricating film. This rheological profile simultaneously maximizes patient comfort and therapeutic efficacy. Clinical TBUT studies confirm significantly longer ocular surface retention for high MW HA (≥1,500 kDa) vs low MW HA (<500 kDa).
This product is manufactured and released in full compliance with the European Pharmacopoeia (EP) monograph 1472 for Sodium Hyaluronate, which specifies: assay (95.0-105.0% on dried basis), intrinsic viscosity limits (2.5-4.5 m³/kg), bacterial endotoxins (<0.5 IU/mg equivalent to <0.5 EU/mg for ophthalmic use — the most stringent parenteral/ophthalmic limit; 100× stricter than cosmetic grade <50 EU/mg), solution clarity (T550nm ≥99.0% in 1 cm cell), absorbance (A280nm ≤0.25), loss on drying (≤10.0%), protein content (≤0.1%), heavy metals (≤10 ppm), iron (≤80 ppm), and microbial limits (TAMC ≤100 CFU/g, specified pathogens negative). Additional testing per EP ophthalmic monograph requirements includes particulate matter (USP <789> — ophthalmic-specific limits vs USP <788> for injectables) and preservative efficacy testing when applicable. Our DMF Type IV provides complete CMC (Chemistry, Manufacturing, and Controls) data — manufacturing process, critical process parameters, in-process controls, specifications, batch analysis (minimum 3 lots), stability data, and container closure information — to support your ANDA (USA), NDA, MAA (EU), or 510(k) (medical device) filing. GMP (ICH Q7) manufacturing with ISO 9001:2015 quality management system.
The clinically established concentration range is 0.1-0.4% w/v for artificial tears and lubricating eye drops. Higher concentrations (0.3-0.4%) provide greater viscosity, longer ocular residence, and more effective tear film stabilization for moderate-to-severe dry eye (aqueous-deficient and evaporative types). Lower concentrations (0.1-0.2%) are suitable for mild dry eye or contact lens applications where minimal visual disturbance is prioritized. Formulation guidelines: Dissolve HA powder in Sterile Water for Injection (SWFI) or buffered saline (phosphate buffer pH 7.2, borate buffer pH 7.4, or bicarbonate buffer) with gentle stirring for 2-4 hours at room temperature. Avoid vortex mixing or high-shear homogenization — these can mechanically degrade high MW HA chains, reducing viscosity and corneal residence time. For preservative-free unit-dose formulations (the preferred format for moderate-to-severe dry eye): filter-sterilize through 0.22 μm PVDF or PES membrane (regenerated cellulose may bind HA) and aseptically fill into single-use LDPE or PP blow-fill-seal (BFS) containers. For multi-dose preserved formulations: HA is compatible with benzalkonium chloride (BAK 0.004-0.01%), polyquaternium-1 (0.001%), and PURITE (stabilized oxychloro complex 0.005%). For OVD applications: 1.0-2.3% w/v HA dissolved in PBS, sterilized by autoclave (121°C, 15-20 min) — validate post-sterilization MW and viscosity.
This eye drops grade HA is suitable as a raw material for ophthalmic viscosurgical devices (OVDs) and other intraocular applications. The EP/DMF/GMP certification, bacterial endotoxin control (<0.5 EU/mg), and high MW (1,600-2,500 kDa) meet the critical quality requirements for intraocular products: (1) Endotoxin level <0.5 EU/mg ensures the raw material does not contribute to Toxic Anterior Segment Syndrome (TASS) — a sterile, non-infectious postoperative inflammatory condition caused by endotoxin or other contaminants introduced during surgery. (2) High MW provides the space-maintaining viscoelasticity required to protect the corneal endothelium during phacoemulsification (ultrasound energy), maintain anterior chamber depth, and facilitate intraocular lens (IOL) implantation. (3) Solution clarity and low absorbance ensure optical transparency during surgery. For specific OVD finished product manufacturing, the following additional processing steps are performed by the finished product manufacturer: dissolution at 1.0-2.3% w/v in buffered saline, adjustment of osmolality to 280-320 mOsm/kg, sterile filtration (0.22 μm), aseptic filling into pre-filled syringes, and terminal sterilization (autoclave 121°C validated per ISO 17665). The final OVD product must meet additional USP <789> particulate matter limits and ISO 10993 biocompatibility requirements.
Every shipment includes a comprehensive ophthalmic-grade documentation package: COA (EP monograph 1472 compliance data — assay 95.0-105.0%, intrinsic viscosity 2.5-4.5 m³/kg, bacterial endotoxins <0.5 EU/mg LAL, solution clarity T550nm ≥99.0%, absorbance A280nm ≤0.25, loss on drying ≤10.0%, residue on ignition ≤20.0%, protein ≤0.1%, nucleic acid ≤0.5%, heavy metals ≤10 ppm, iron ≤80 ppm, glucuronic acid 42.0-48.0%, pH 5.0-7.5, microbial limits per USP <61>/<62> with P. aeruginosa and S. aureus negative), MSDS, DMF Type IV Letter of Authorization (cross-reference for ANDA/NDA/510(k) filing), CMC Data Package (manufacturing process, CPPs/CQAs, in-process controls, batch analysis — minimum 3 lots), BSE/TSE-Free Statement (fermentation-derived — no animal materials), Stability Data (25°C/60%RH 36-month real-time; 40°C/75%RH 6-month accelerated; MW, viscosity, endotoxin, and solution clarity re-verified at 3/6/12/24/36 months), and Complete Lot Traceability from fermentation batch to finished powder. Free sample available for qualified B2B buyers. MOQ: 100 g for pilot evaluation. All documents in English.