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Artificial Tears Raw Material Sodium Hyaluronate Powder
Product specification
| Brand Name | MHW CHEM |
| Model Number | MHW-FU-2026063 |
| Product Name | Sodium Hyaluronate |
| Chemical Formula | (C14H20NNaO11)n |
| Chemical Structure |
 |
| CAS No. | 9067-32-7 |
| 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 |
| MOQ | 100 grams |
Core Benefits
High Viscoelasticity and Biomimetic Lubrication: The rheological characteristics of sodium hyaluronate are highly similar to the mucins in natural human tears. Its shear-thinning properties reduce viscosity at high shear rates (e.g., during blinking), preventing blurred vision; and increase viscosity at low shear rates (e.g., when the eyes are open), prolonging tear film breakup time.
Ultra-Low Endotoxin and Ultra-High Safety: Specially optimized for ophthalmic applications, endotoxin control is far stricter than that of ordinary cosmetic-grade raw materials. It is non-immunogenic and does not irritate corneal endothelial cells.
Promotes Corneal Repair: Clinically proven, high-purity sodium hyaluronate not only hydrates but also binds to receptors on the corneal surface, promoting corneal epithelial cell migration and healing.
Strict Compliance: The production line is GMP certified and provides enterprise standard (MSDS) and COA test reports, supporting global pharmaceutical/medical device registration and filing.
Manufacturing Process & Quality Control
1. Fermentation: High-density deep liquid fermentation is conducted using carefully selected non-GMO streptococci, with strict control over temperature, pH, and dissolved oxygen levels to ensure efficient secretion of high molecular weight hyaluronic acid.
2. Filtration & Sterilization: After fermentation, multi-stage precision filtration and high-pressure sterilization thoroughly kill the producing bacteria and separate a clear hyaluronic acid coarse filtrate.
3. Purification & Deprogenation: Advanced ultrafiltration and adsorption technologies are used to selectively remove nucleic acids, proteins, and bacterial endotoxins. This is a crucial process determining whether ophthalmic eye drop quality can be achieved.
4. Alcohol Precipitation: Gradient precipitation with pharmaceutical-grade ethanol crystallizes sodium hyaluronate from the aqueous solution, further desalting and improving product purity.
5. Aseptic Vacuum Drying: Low-temperature vacuum drying is performed in a sterile Class 100 clean area to avoid molecular weight degradation caused by high temperatures and to precisely control product weight loss during drying.
6.Milling, Packing & QC: The product is milled into a uniform fine powder by airflow and then aseptically double-sealed. Each batch of product must pass rigorous QC testing, including high-performance liquid chromatography (HPLC), and a Certificate of Analysis (COA) is issued before release.
Packaging & Storage
▪ Standard Packaging: 100g/aluminum foil bag, 1kg/bag, or customized aseptic double-layer packaging according to customer's API production requirements.
▪ Storage Conditions: Sealed, protected from light and moisture. For long-term pharmaceutical-grade storage, it is recommended to store in a cool place at 2-8°C.
▪ Shelf Life: 24 months in unopened original packaging that meets standards.