Eye drop grade hyaluronic acid powder - GMP Compliant Supplier

Eye Drop Grade Hyaluronic Acid (HA) Powder is a highly pure form of HA, specifically formulated for ophthalmic applications. Produced through natural fermentation, it ensures excellent biocompatibility and safety for sensitive eye tissues. This grade of HA offers superior viscoelasticity and lubricating properties, making it ideal for moisturizing and protecting the eye surface.

Princeton Powder is a leading supplier of medical grade sodium hyaluronate powder manufactured under strict GMP conditions. Our USP-NF compliant hyaluronic acid powder meets the highest standards for purity and sterility required for medical applications including joint injections, ophthalmic surgery, and wound healing formulations.

Princeton Powder is a leading supplier of pharmaceutical-grade hyaluronic acid powder, providing HA with low endotoxin levels at competitive prices in the USA.

Formula

[C14H22NNaO11]n

Synonyms

Sodium Hyaluronate, Hyaluronic Acid, HA

Appearance

White to off-white Powder

CAS number

9067-32-7

Purity

>95% 

Source

Fermentation

 classification

High Molecular weight HMW Hyaluronic Acid

Middle Molecular weight Hyaluronic Acid

Low Molecular weight LMW Hyaluronic Acid

Hydrolyzed hyaluronic Acid

Storage

Cool Dry Place

Description of Eye drop grade HA powder

Eye Drop Grade Hyaluronic Acid (HA) Powder is known for its exceptional moisture-retaining, viscoelastic, and lubricating properties, making it ideal for soothing, hydrating, and protecting the eye surface.

In eye drop formulations, HA provides long-lasting hydration, helping to alleviate dryness, irritation, and discomfort caused by environmental factors, extended screen time, or contact lens use. Its high molecular weight forms a protective, lubricating film over the cornea, offering relief from dry eyes and improving tear film stability. Eye drop grade HA powder is free from harmful additives and features low endotoxin levels, ensuring safety and comfort for sensitive eyes.

This versatile ingredient is commonly used in eye drops, contact lens solutions, and post-surgery eye care products, offering reliable hydration and lubrication to enhance eye health.

Technical Specifications of pharmaceutical grade HA Powder

Eyedrop Grade Hyaluronic Acid

HAE-2.0

M.W. 600-1,300k Da

EP 9.0 Standard,

DMF Certificate

HAE-3.0

M.W. 1,600-2,500k Da

ParameterSpecificationTest Method
AppearanceWhite to off-white free-flowing powderVisual inspection
Purity (Sodium Hyaluronate)≥ 99.9%HPLC
Molecular Weight600 kDa – 2.5 MDa (custom ranges available)Size Exclusion Chromatography
Endotoxin Level< 0.05 EU/mgLAL test
Protein Content< 0.1%BCA assay
Heavy Metals< 10 ppmICP-MS
Microbial LimitsSterile (CFU/g < 10)USP <61>, <62>
pH (1% solution)6.0 – 7.5pH meter
Loss on Drying< 8.0%Thermogravimetric analysis

Key Benefits of Medical Grade Sodium Hyaluronate Powder

  • Ultra-High Purity: 99.9% pure sodium hyaluronate with ultra-low endotoxin levels (<0.05 EU/mg)
  • Regulatory Compliance: Meets USP-NF, European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP) standards
  • Sterility Assurance: Manufactured in ISO Class 7 cleanroom facilities with terminal sterilization options
  • Batch-to-Batch Consistency: Rigorous quality control ensures uniform molecular weight distribution
  • Medical Device Compatibility: Formulated for ophthalmic viscoelastic devices, joint injection systems, and wound care products
  • Technical Support: Dedicated medical applications team for formulation assistance and regulatory guidance

Application of pharmaceutical grade HA Powder

1. Ophthalmic Surgery

Viscoelastic Procedures: Cataract surgery, corneal transplantation, glaucoma surgery

Key Requirements: High viscosity, excellent elastic properties, transparent solutions

Molecular Weight: 1.5-2.5 MDa for optimal viscoelastic properties

2. Orthopedic Injections

Intra-articular Therapies: Osteoarthritis treatment, viscosupplementation

Key Requirements: Specific molecular weight profiles, sterile pyrogen-free formulations

Molecular Weight: 500 kDa – 1.2 MDa for joint lubrication and shock absorption

3. Wound Healing & Dermatology

Advanced Wound Care: Diabetic ulcers, surgical wounds, burn treatment

Key Requirements: Hydration properties, biocompatibility, promotion of tissue regeneration

Molecular Weight: Various ranges for different formulation types

4. Drug Delivery Systems

Sustained Release Formulations: Ocular drug delivery, topical therapeutics

Key Requirements: Controlled viscosity, mucoadhesive properties, biocompatibility

Molecular Weight: Customized based on release profile requirements

Technical Documentation

Complete regulatory and technical documentation available:

Certificate of Analysis (Sample) – Batch-specific quality testing results
Drug Master File (DMF) Abstract – Regulatory submission support document
Material Safety Data Sheet (MSDS) – Safety and handling information
Stability Study Data – Long-term stability under various conditions
Biocompatibility Test Reports – ISO 10993 testing results
Sterilization Validation Reports – Sterilization method validations

Pharmaceutical grade HA Powder Reference

A Meta-Analysis of the Efficacy of Hyaluronic Acid Eye Drops for the Treatment of Dry Eye Syndrome

  • Hyaluronic acid (HA) is commonly used for treating dry eye syndrome (DES). This meta-analysis was performed to compare the efficacies of HA- and non-HA-based eye drops, including saline and conventional artificial tears (ATs), for the treatment of dry eye disease.

Frequently Asked Questions

Q1: What’s the difference between medical grade and cosmetic grade sodium hyaluronate?

A: Medical grade sodium hyaluronate powder has stricter purity requirements, lower endotoxin levels (<0.05 EU/mg vs. <0.5 EU/mg), and meets pharmacopeia standards (USP-NF, EP, JP). It’s manufactured under GMP conditions with full traceability and sterility assurance for medical applications.
 

Q2: Do you offer different molecular weight options?

A: Yes, we offer medical grade sodium hyaluronate powder in various molecular weight ranges: Low (500-800 kDa) for enhanced tissue penetration, Medium (800 kDa – 1.2 MDa) for balanced properties, and High (1.5-2.5 MDa) for superior viscoelasticity in ophthalmic applications.
 

Q3: What sterilization methods are available?

A: We offer terminal sterilization options including gamma irradiation (25-40 kGy), ethylene oxide (EtO), and aseptic processing. Each method is validated with comprehensive sterilization validation reports available.
 

Q4: Can you provide regulatory submission support?

A: Yes, we provide comprehensive regulatory support including Drug Master Files (DMF), biocompatibility test reports (ISO 10993), and technical documentation packages for FDA, EMA, and other regulatory agency submissions.
 

Q5: What’s the minimum order quantity?

A: We offer flexible quantities from R&D samples (5-50g) to commercial batches (1kg+). Sample kits are available for formulation development and testing.