Based on Ph.Eur. 11.0 with ophthalmic-specific endotoxin limit (< 0.5 IU/mg). Actual COA provided per batch upon request.
| Test Item | Specification | Test Method | Remarks |
|---|---|---|---|
| Identification & Appearance | |||
| Appearance | White or almost white powder or granule | ||
| Identification A (IR) | Conforms to Ph.Eur. reference spectrum | ||
| Identification B (Na) | Positive reaction of sodium | ||
| Appearance of Solution | Clear; A₆₀₀ₙₘ ≤ 0.01 | ||
| Chemical Assay | |||
| Assay (Sodium Hyaluronate) | 95.0% – 105.0% | ||
| Intrinsic Viscosity | Measured value (reported) | ||
| Average Molecular Weight | Per grade specification | ||
| Physical & Chemical Properties | |||
| pH (0.5% solution, 25°C) | 5.0 – 8.5 | ||
| Loss on Drying | ≤ 20.0% | ||
| Protein Content | ≤ 0.1% | ||
| Chlorides | ≤ 0.5% | ||
| Iron | ≤ 80 ppm | ||
| Nucleic Acids | A₂₆₀ₙₘ ≤ 0.05 | ||
| Residual Solvent (Ethanol) | ≤ 0.5% | ||
| Heavy Metals | |||
| Heavy Metals (as Pb) | ≤ 10 ppm | ||
| Microbiological & Endotoxin | |||
| Microbial Contamination | ≤ 100 CFU/g | ||
| Bacterial Endotoxins | < 0.5 IU/mg | ||
| Packaging & Storage | |||
| Packaging | 1 kg / 5 kg (upon request) | ||
| Storage Condition | Cool, dry, away from light | ||
| Shelf Life | 36 months | ||
Ophthalmic grade HA carries an endotoxin limit of < 0.5 IU/mg — appropriate for eye-drop and topical ophthalmic applications. This differs from injectable grade (< 0.05 IU/mg), which requires a 10× stricter limit for parenteral use. Please specify your application when requesting documentation.
| MW Grade | Range | Viscosity in Solution | Recommended Application |
|---|---|---|---|
| Low MW | 10,000 – 400,000 Da | Low — easy to instill | Low-viscosity artificial tears, comfort drops |
| Medium MW | 400,000 – 1,500,000 Da | Medium — extended retention | Standard artificial tears, dry eye formulations |
| High MW | 1,500,000 – 2,200,000 Da | High — prolonged ocular surface residence | Long-lasting relief formulas, gel eye drops |
Solution clarity A₆₀₀ₙₘ ≤ 0.01 — ultra-clear aqueous solutions with no visible particles, essential for direct ocular contact applications.
LAL-tested endotoxin limit specifically calibrated for ophthalmic applications — safe for direct contact with ocular tissues and mucosal membranes.
No animal-tissue contamination risk. Clean fermentation origin with full batch traceability — essential for ophthalmic regulatory submissions.
Protein ≤ 0.1% and nucleic acids controlled (A₂₆₀ₙₘ ≤ 0.05) — minimizing immunogenic and irritation risk for sensitive ocular surface applications.
High MW grades exhibit shear-thinning behavior — low viscosity during instillation (blink/drop), returning to high viscosity on the ocular surface for extended retention.
Full compliance documentation with European Pharmacopoeia 11.0 standards — supporting CE marking, EU MDR, and NMPA ophthalmic product registrations.
The primary application — HA-based artificial tear formulations for dry eye disease treatment. Medium to high MW grades preferred for extended ocular surface retention.
Preservative-free multi-dose or unit-dose dry eye drops. HA concentration typically 0.1%–0.3% depending on MW and desired viscosity profile.
Ophthalmic viscosurgical devices (OVDs) used during cataract and other intraocular surgeries — requires high MW and strict endotoxin control.
Carrier matrix for prolonged ocular drug delivery — HA extends corneal contact time and improves bioavailability of co-formulated active pharmaceutical ingredients.
GRAS, fermentation-derived — for dietary supplements and functional foods.
Learn More →Ph.Eur. compliant — endotoxin < 0.05 IU/mg for oral pharma products.
Learn More →Strictest endotoxin control < 0.05 IU/mg — for dermal fillers and joint injections.
Learn More →Contact us for batch COA, endotoxin test reports, Ph.Eur. documentation, and pricing based on your required MW grade and order volume.