Sodium Hyaluronate Powder Eye Drops Grade M.W 600-1,300 kDa — EP/DMF/GMP Certified Supplier
Mid-molecular weight ophthalmic-grade sodium hyaluronate (600-1,300 kDa) — the optimal balance of corneal residence time and sterile filterability for preservative-free eye drop manufacturing. EP/DMF/GMP certified with bacterial endotoxin <0.5 EU/mg. Engineered for aseptic filtration through 0.22 μm sterilizing-grade membranes at clinically relevant concentrations (0.1-0.4% w/v) — eliminating the manufacturing bottleneck of high-viscosity ultra-high MW HA solutions. Excellent solution clarity (T550nm ≥99.0%), reliable syringeability, and consistent drop formation. Ideal for preservative-free unit-dose dry eye products, multi-dose ophthalmic solutions, and contact lens care. 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 600-1,300 kDa) is an ophthalmic-grade HA with a mid-molecular weight range optimized for the manufacturing practicality of sterile-filterable eye drop production. This MW range (600-1,300 kDa) provides the ideal balance of therapeutic efficacy and processability: the polymer chains are long enough to provide effective mucoadhesion, corneal lubrication, and tear film stabilization — yet short enough to enable aseptic filtration through 0.22 μm sterilizing-grade membranes at clinically relevant concentrations (0.1-0.4% w/v). This is the critical manufacturing advantage over ultra-high MW HA (≥1,500 kDa) which, while providing maximum corneal residence time, produces solutions too viscous to sterile-filter efficiently — requiring heat sterilization (autoclave 121°C, 15-20 min) which can cause polymer chain degradation and MW reduction, introducing batch-to-batch variability in finished product viscosity and clinical performance. Mid-MW HA eliminates this manufacturing bottleneck: the lower intrinsic viscosity (1.0-2.5 m³/kg vs 2.5-4.5 m³/kg for high MW) enables reliable 0.22 μm filtration with acceptable flow rates and filter capacity, preserving the MW distribution and ensuring consistent finished product performance. The mucoadhesive properties of HA are present across the entire MW range — the carboxyl (-COO⁻) and hydroxyl (-OH) groups that hydrogen-bond with the mucin glycoprotein layer (primarily MUC5AC secreted by conjunctival goblet cells) of the tear film are independent of polymer chain length. Clinical studies confirm that mid-MW HA (600-1,300 kDa) eye drops at 0.1-0.4% w/v significantly improve tear film break-up time (TFBUT), reduce corneal fluorescein staining scores, and relieve dry eye symptoms (OSDI score reduction) comparable to higher MW formulations. UPOR Biotech manufactures this grade under full EP (monograph 1472), DMF Type IV, and GMP (ICH Q7) conditions with bacterial endotoxin control <0.5 EU/mg and comprehensive regulatory documentation.
As a specialized ophthalmic-grade HA manufacturer and bulk supplier, UPOR Biotech provides mid-MW sodium hyaluronate for B2B ophthalmic pharmaceutical companies and contract manufacturers developing preservative-free unit-dose artificial tears, multi-dose lubricating eye drops, and contact lens care products worldwide. The mid-MW range's sterile filterability makes it the preferred choice for blow-fill-seal (BFS) aseptic manufacturing — the dominant format for preservative-free single-use ophthalmic products. OEM formulations and DMF Type IV support available. Free sample available for qualified B2B buyers.
Mid-MW HA — The Practical Ophthalmic Grade for Sterile Filtration
Unlike ultra-high MW HA (>2,000 kDa) which can be impossible to sterile-filter at clinically relevant concentrations, mid-MW HA (600-1,300 kDa) passes through 0.22 μm sterilizing-grade membranes with acceptable flow rates — enabling aseptic manufacturing of preservative-free unit-dose eye drops. Heat sterilization (autoclave) of high MW HA solutions degrades the polymer chains, reducing MW and causing batch-to-batch viscosity variability. Mid-MW HA avoids this: aseptic filtration preserves the MW distribution, ensuring consistent finished product performance. Yet it retains sufficient chain length for effective mucoadhesion, corneal surface protection, and tear film stabilization. For ophthalmic formulators, this MW range is the manufacturing-compatible sweet spot — combining therapeutic performance with practical processability for preservative-free unit-dose, multi-dose, and contact lens care products.
Technical Specifications
| Property | Specification |
|---|---|
| Product Name | Sodium Hyaluronate Powder — Eye Drops Grade (Mid-MW) / Ophthalmic Grade |
| Grade | Eye Drops Grade / Medical Grade — EP/DMF/GMP Certified |
| CAS Number | 9067-32-7 (Sodium Hyaluronate) |
| Molecular Weight Range | 600 – 1,300 kDa (Mid-MW — GPC-MALLS verified) |
| Key Advantage | Sterile-filterable ophthalmic HA — passes 0.22 μm membrane at 0.1-0.4% w/v. Optimal balance of corneal residence time and manufacturing processability. EP/DMF/GMP with endotoxin <0.5 EU/mg. |
| Appearance | White to off-white powder; hygroscopic |
| Assay — Sodium Hyaluronate (Dry Basis) | 95.0 – 105.0% (EP monograph 1472) |
| Glucuronic Acid Content | 42.0 – 48.0% (carbazole method) |
| Intrinsic Viscosity | 1.0 – 2.5 m³/kg (EP monograph 1472 — lower than high MW grade enables sterile filtration) |
| Kinematic Viscosity (0.5% w/v, 25°C) | 10 – 40 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) |
| Absorbance (A280nm, 0.5% w/v) | ≤0.25 (low protein/nucleic acid — EP requirement) |
| Bacterial Endotoxins | <0.5 EU/mg (LAL kinetic chromogenic — EP ophthalmic limit) |
| Sterile Filterability — Critical Quality Attribute | Passes 0.22 μm PVDF or PES membrane at 0.1-0.4% w/v with acceptable flow rate and filter capacity (validated per PDA Technical Report 26) |
| Sterility | Controlled microbial limits per EP ophthalmic monograph (USP <71> on finished sterile-filtered product) |
| Protein Content | ≤0.1% |
| Nucleic Acid | ≤0.5% |
| Loss on Drying | ≤10.0% |
| Residue on Ignition | ≤20.0% |
| Heavy Metals (Total) | ≤10 ppm (as Pb) |
| Iron (Fe) | ≤80 ppm |
| 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 — dissolves faster than high MW grades (1-2 hours gentle stirring for 0.5% w/v at 25°C) |
| Recommended Concentration — Eye Drops | 0.1 – 0.4% w/v (sterile-filterable across entire range) |
| Sterilization Method | Aseptic filtration (0.22 μm) recommended; autoclave compatible (121°C, 15-20 min — validate post-sterilization MW) |
| Certifications | EP Monograph 1472, DMF Type IV, GMP ICH Q7, ISO 9001:2015, FDA Facility Registration, HALAL, KOSHER, BSE/TSE-Free |
| Packaging | 100 g / 1 kg / 5 kg / 25 kg pharmaceutical-grade HDPE containers with desiccant |
| Storage | 2-8°C recommended; tightly sealed; protect from moisture and light |
| Shelf Life | 36 months under recommended storage; MW, viscosity, filterability, and endotoxin verified at 3/6/12/24/36 months |
Key Benefits — HA Eye Drops Grade (Mid-MW)
Sterile-Filterable at Clinical Concentrations — Manufacturing-Ready
The 600-1,300 kDa MW range is specifically selected for 0.22 μm filterability at 0.1-0.4% w/v. Unlike ultra-high MW HA requiring heat sterilization (which degrades polymer chains), mid-MW HA enables aseptic filtration — preserving MW integrity and ensuring batch-to-batch viscosity consistency for preservative-free unit-dose products.
Sterile FilterableEP/DMF/GMP Certified — Endotoxin <0.5 EU/mg
Full EP monograph 1472 compliance, DMF Type IV support, and GMP (ICH Q7) manufacturing. Bacterial endotoxin <0.5 EU/mg — meets FDA, EMA, and global ophthalmic product regulatory requirements for ANDA/NDA/MAA/510(k) filing.
Ophthalmic CertifiedBalanced Therapeutic Performance — Clinically Effective
Provides effective mucoadhesion, corneal lubrication, and tear film stabilization. Clinical studies confirm mid-MW HA eye drops significantly improve TFBUT, reduce corneal staining, and relieve dry eye symptoms (OSDI scores) comparable to high MW formulations — with superior manufacturing practicality.
Clinically EffectiveExcellent Solution Clarity and Syringeability
Mid-MW HA solutions at 0.1-0.4% w/v exhibit low turbidity (T550nm ≥99.0%), consistent drop formation from ophthalmic dropper tips, and smooth syringeability through fine-gauge needles — critical quality attributes for eye drop products and aseptic filling operations.
Crystal ClearApplications
Preservative-Free Unit-Dose Eye Drops — BFS Manufacturing
Sterile-filterable for single-use, preservative-free dry eye formulations. Mid-MW HA enables 0.22 μm aseptic filtration at 0.1-0.4% w/v — essential for blow-fill-seal (BFS) unit-dose ophthalmic products where preservatives are not used.
Multi-Dose Dry Eye Products — Preserved Formulations
Lubricating eye drops with superior processability. Mid-MW HA provides good corneal residence time while allowing efficient filtration during manufacturing. Compatible with BAK, polyquaternium-1, and PURITE preservative systems.
Contact Lens Solutions — Rewetting and Multipurpose
Rewetting drops and lens packaging solutions. Mid-MW HA provides lens surface lubrication without the high viscosity that causes blurring or residue. Compatible with silicone hydrogel and hydrogel soft contact lens materials.
Post-Surgical Ophthalmic Care — Recovery Formulations
Post-cataract, post-LASIK, and post-corneal transplant recovery drops. Sterile, endotoxin-controlled mid-MW HA for corneal surface protection and enhanced epithelial wound healing via CD44-mediated migration during post-operative recovery.
Ophthalmic Drug Delivery — Mucoadhesive Vehicle
Viscosity-enhancing vehicle for ophthalmic APIs (antibiotics, anti-inflammatories, anti-glaucoma). Mid-MW HA prolongs corneal residence time for improved drug bioavailability while maintaining sterile filtration compatibility.
Dual-MW Formulations — Mid-MW + High-MW Blends
Advanced formulation strategy: combine 70-90% mid-MW HA (filterability) with 10-30% high-MW HA (enhanced residence time). Creates premium dual-MW dry eye products with broader therapeutic profiles and manufacturing compatibility.
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 |
| Eye Drops Grade Mid MW (this product) | 600-1,300 kDa | Sterile-filterable ophthalmic HA: preservative-free eye drop manufacturing, corneal mucoadhesion, tear film stabilization | Corneal surface (tear film/mucin layer adhesion) |
| 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 | 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
Manufacturing practicality. Mid-MW HA solutions can be sterile-filtered through 0.22 μm membranes at clinically relevant concentrations (0.1-0.4% w/v), while high-MW HA (>1,500 kDa) solutions at these concentrations are often too viscous to filter efficiently — requiring heat sterilization (autoclave 121°C) which causes polymer chain degradation, MW reduction, and batch-to-batch viscosity variability. For preservative-free unit-dose products where aseptic filtration is the preferred sterilization method (preserving MW integrity and ensuring consistent finished product performance), mid-MW HA is the practical choice that still delivers clinically effective corneal lubrication and hydration. The lower intrinsic viscosity (1.0-2.5 vs 2.5-4.5 m³/kg for high MW) enables reliable filtration with acceptable flow rates, filter capacity, and no MW loss — critical for validated aseptic manufacturing processes.
Yes. While mid-MW HA has slightly shorter ocular residence time than ultra-high MW HA, clinical studies demonstrate that HA at 600-1,300 kDa still provides significantly prolonged corneal surface retention compared to low-MW HA (<500 kDa) or saline controls. The mucoadhesive properties of HA — carboxyl (-COO⁻) and hydroxyl (-OH) groups that form hydrogen bonds with the MUC5AC mucin glycoprotein layer of the tear film — are independent of polymer chain length. Mid-MW HA represents the optimal balance: long enough for clinical efficacy (significantly improved TFBUT, reduced corneal fluorescein staining, OSDI score reduction), short enough for manufacturing practicality (0.22 μm sterile filtration at clinical concentrations). Studies show mid-MW HA eye drops perform comparably to higher MW formulations in dry eye symptom relief while offering superior processability.
Full compliance with the European Pharmacopoeia monograph for Sodium Hyaluronate (EP 1472) is verified for every batch: assay 95.0-105.0% (dry basis), intrinsic viscosity 1.0-2.5 m³/kg, bacterial endotoxins <0.5 EU/mg (LAL kinetic chromogenic method — the most stringent parenteral/ophthalmic limit), solution clarity T550nm ≥99.0%, absorbance A280nm ≤0.25, glucuronic acid content 42.0-48.0%, protein ≤0.1%, heavy metals ≤10 ppm, iron ≤80 ppm, loss on drying ≤10.0%, residue on ignition ≤20.0%, and microbiological purity per Ph. Eur. category 2 requirements for ophthalmic preparations (TAMC ≤100 CFU/g, TYMC ≤50 CFU/g, P. aeruginosa and S. aureus negative). Our DMF Type IV provides complete CMC data — manufacturing process, CPPs/CQAs, in-process controls, batch analysis (minimum 3 lots), stability data, and container closure information — to support your ANDA/NDA/MAA/510(k) filing.
Yes, and this is an advanced premium formulation strategy. Combining mid-MW HA (600-1,300 kDa) with a smaller fraction of high-MW HA (>1,500 kDa) creates a dual-MW eye drop that delivers both manufacturing processability and enhanced therapeutic performance. The mid-MW fraction (70-90% of total HA) ensures the formulation can be aseptically filtered through 0.22 μm membranes; the high-MW fraction (10-30%) provides extended corneal surface retention and enhanced viscoelastic protection. Typical ratios: 70:30 to 90:10 (mid-MW:high-MW). Since both components are the same chemical entity (sodium hyaluronate) differing only in chain length, they form a single-phase solution with rheological properties (viscosity, shear-thinning behavior) intermediate between the two individual MW grades. Formulators should conduct viscosity, filterability, and clinical performance studies to determine the optimal blend ratio for their target product profile and manufacturing equipment.
Every shipment includes: COA (EP monograph 1472 full compliance — assay, intrinsic viscosity, bacterial endotoxins <0.5 EU/mg LAL, solution clarity T550nm, absorbance A280nm, glucuronic acid, protein, heavy metals, iron, loss on drying, residue on ignition, microbial limits per USP <61>/<62> with P. aeruginosa and S. aureus negative, filterability confirmation), MSDS, DMF Type IV Letter of Authorization, CMC Data Package (manufacturing process, CPPs/CQAs, batch analysis minimum 3 lots), BSE/TSE-Free Statement, Stability Data (36-month real-time; 6-month accelerated; MW, viscosity, filterability, endotoxin re-verified at 3/6/12/24/36 months), and Complete Lot Traceability. ISO 9001:2015, GMP ICH Q7, FDA registered, HALAL, KOSHER. Free sample available. MOQ: 100 g.