China Pharmaceutical Grade Hyaluronic Acid for Injection Manufacturers, Exporters

Pharmaceutical-grade injectable hyaluronic acid refers to high-purity hyaluronic acid raw materials that meet the requirements for use in injectable pharmaceutical preparations. It is specifically developed for joint, ophthalmic, and other injectable drug delivery systems. This product is prepared through a controlled bio-fermentation process and undergoes purification and testing under a rigorous quality management system to ensure that it meets pharmaceutical application standards in terms of safety, biocompatibility, and stability.

Product Description

Product Specification

Model Number FU-2025013
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 95.0%~105.0%
Application Medical applications
Function Treatment of joint diseases and adjunctive ophthalmic surgery
Solubility Soluble in water
Heavy metals ≤10ppm
Protein ≤0.1%
Bacterial endotoxins ≤0.05IU/mg
Source Microbial fermentation
Packaging 100g/foil bag, 1kg/foil bag or as per customer's request.
Shelf life 2 years
Storage conditions Avoid light, refrigerate 2℃~10℃, seal container.

Features

  • Utilizes a microbial fermentation route, ensuring stable raw material sources and avoiding animal-derived risks.
  • Multi-stage purification and fine separation processes effectively control impurities and insoluble substances.
  • Controllable molecular weight distribution and stable physicochemical properties facilitate injectable formulation design.
  • Possesses excellent solubility and gelling ability, suitable for various injection systems.
  • Stable rheological properties during injection, ensuring a consistent user experience.

Advantages

  • Low levels of protein residue, endotoxins, and heavy metals ensure high injection safety.
  • Excellent batch-to-batch consistency, suitable for long-term and large-scale production needs.
  • Complies with pharmaceutical-grade quality management standards, with comprehensive testing items and strong traceability.
  • Reliable stability helps extend the shelf life and usage period of formulations.

Applications

  • Intra-articular injection lubricants and adjuvant therapies.
  • Ophthalmic injectable formulations and related drug systems.
  • As a functional excipient or active ingredient in pharmaceutical injectable formulations.
  • Other injectable medical products with high safety and quality standards.

Frequently Asked Questions

Q1: What is the source of this Hyaluronic Acid?
A1: It is derived from microbial fermentation. This ensures a stable raw material source and effectively avoids risks associated with animal-derived pathogens.
Q2: What are the main medical applications for this product?
A2: It is used in medical applications such as intra-articular injection lubricants for the treatment of joint diseases, and as an adjuvant in ophthalmic surgeries.
Q3: How are impurities and safety controlled in this product?
A3: The product undergo multi-stage purification and fine separation processes. It maintains low levels of protein residue (≤0.1%), heavy metals (≤10ppm), and bacterial endotoxins (≤0.05IU/mg) to ensure high injection safety.
Q4: Is the product easily soluble, and what are its physical properties?
A4: Yes, it is soluble in water and features excellent gelling ability. It possesses controllable molecular weight distribution and stable rheological properties, making it highly suitable for injectable formulations.
Q5: What are the recommended storage conditions and shelf life?
A5: It has a shelf life of 2 years when stored in a sealed container, kept away from light, and refrigerated at temperatures between 2℃ and 10℃.

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