High-Quality Ophthalmic Grade Hyaluronic Acid Powder EP Standard Manufacturer, Service

Ophthalmic grade hyaluronic acid powder is a linear polysaccharide naturally found in human eye tissues, possessing excellent water retention, lubricity, and viscoelasticity. In ophthalmic surgery, it is primarily used to maintain anterior chamber space, protect corneal endothelial cells, and reduce surgical trauma. The product is manufactured strictly according to EP pharmacopoeia standards, ensuring it meets pharmaceutical-grade requirements in terms of aseptic control, endotoxin content, and protein residue.

Product Description

Product Specification

Product Name Hyaluronic Acid
Chemical Formula (C14H21NO11)n
Chemical Structure Chemical Structure of Hyaluronic Acid
CAS No. 9004-61-9
Appearance White, fine powder
Assay ≥99.5%
Solubility Soluble in water
Heavy metals ≤10ppm
Protein ≤0.1%
Bacterial endotoxins ≤0.5IU/mg
Source Microbial fermentation

Product Features

Pharmaceutical-Grade Purity

Strictly controlled according to European Pharmacopoeia (EP) standards. It features low endotoxin content, minimal protein residue, and strictly controlled microbial limits, fully meeting requirements for ophthalmic and injectable applications.

High Safety & Biocompatibility

As a naturally occurring component in the human body, it exhibits excellent tissue compatibility. It does not cause significant immune responses after implantation into the eye and can be naturally degraded safely within the body.

Zero Animal-Derived Risks

Produced using a Streptococcus fermentation process. This bio-fermentation method avoids potential risks associated with animal-derived raw materials and ensures a stable supply chain that meets international regulatory standards.

Main Application Areas

Ophthalmic Surgery (OVD)

Widely used as a Viscoelastic Agent (OVD) raw material in cataract surgery, glaucoma surgery, and corneal transplantation to maintain anterior chamber space, stabilize the surgical environment, and protect intraocular tissues.

Ocular Lubricants & Tears

Key ingredient in formulation developments related to dry eye syndrome. It provides long-lasting lubrication, enhances ocular surface comfort, and significantly reduces irritation.

Drugs & Medical Devices

Ideal for formulation development of ophthalmic injectable preparations, sustained-release drug delivery systems, and high-end ophthalmic medical devices due to its high compatibility and stability.

Why Choose Us?

  • Compliance Guarantee Complete documentation support is provided, including Certificate of Analysis (COA), MSDS, and comprehensive support for registration and regulatory filing.
  • Excellent Stability Proven by accelerated stability testing showing that the active ingredient degradation rate remains extremely low under recommended storage conditions.
  • Sustainable Supply Chain Our bio-fermentation production method ensures zero risk of animal-derived virus transmission, matches sustainable standards, and meets vegan requirements.

Frequently Asked Questions

What purity standards does your Hyaluronic Acid meet?

Our Hyaluronic Acid is pharmaceutical-grade, complying with the European Pharmacopoeia (EP) standards. It has strictly controlled microbial limits, extremely low endotoxins (≤0.5IU/mg), and minimal protein residue (≤0.1%).

What is the source of the raw material?

It is produced via microbial fermentation using a Streptococcus process. This ensures that the product is entirely non-animal-derived, eliminating virus transmission risks and meeting strict vegan standards.

Is this product safe for ophthalmic surgeries?

Yes, because Hyaluronic Acid is naturally present in the human body, it offers excellent tissue compatibility and biocompatibility. It is naturally degraded by the body without triggering significant immune responses, making it ideal for Ophthalmic Viscoelastic Devices (OVD).

Can this Hyaluronic Acid be used in dry eye treatments?

Absolutely. It is widely used in artificial tears and ocular surface lubricants to treat dry eye syndrome by providing long-lasting lubrication and reducing irritation.

What documentation and compliance support do you offer?

We supply complete compliance verification documents, including a detailed Certificate of Analysis (COA), Material Safety Data Sheets (MSDS), and structured support for registration and filing.

How stable is the Hyaluronic Acid under standard storage?

Accelerated stability testing shows that the active ingredient maintains a highly stable profile with an extremely low degradation rate under recommended storage conditions.

Related Products