Compliant with European Pharmacopoeia 11.0 monograph for Sodium Hyaluronate. Enterprise internal control standard Q/RXSW. Actual COA provided per batch.
| 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 | < 0.05 IU/mg | ||
| Packaging & Storage | |||
| Packaging | 1 kg / 5 kg (upon request) | ||
| Storage Condition | Cool, dry, away from light | ||
| Shelf Life | 36 months | ||
| MW Grade | Range | Intrinsic Viscosity (m³/kg) | Recommended Application |
|---|---|---|---|
| Low MW | 10,000 – 400,000 Da | ~0.4 – 1.2 | Oral pharmaceutical formulations, medical-grade solutions |
| Medium MW | 400,000 – 1,500,000 Da | ~1.2 – 3.0 | Pharmaceutical gels, joint health drug products |
| High MW | 1,500,000 – 2,200,000 Da | ~3.0 – 4.5 | Viscosupplementation drug products, medical devices |
Full compliance with the European Pharmacopoeia 11.0 monograph for Sodium Hyaluronate — the global gold standard for pharmaceutical-grade HA quality control.
100% microbial fermentation origin with no animal tissue contamination risk. Full process traceability documentation available for regulatory filings.
Bacterial endotoxin < 0.05 IU/mg (LAL test, Ph.Eur. 2.6.14) — meeting the strict endotoxin threshold required for pharmaceutical drug product applications.
Ethanol residual solvent ≤ 0.5% tested per Ph.Eur. 2.4.24 — comprehensive process purity control for pharmaceutical regulatory submissions.
Nucleic acids (A₂₆₀ₙₘ ≤ 0.05) and iron (≤ 80 ppm) tested — pharmaceutical-specific impurity controls not required in food or cosmetic grades.
COA, TDS, MSDS, DMF support documentation, and GMP certificates available to support IND/NDA filings in EU, US, and APAC markets.
Tablets, capsules, and oral solutions for joint health drug registration — particularly in EU and Asian markets where pharmaceutical-grade HA is mandated.
Class II/III medical device formulation ingredient requiring pharmacopoeia-grade raw materials with full traceability and endotoxin documentation.
Precursor material for intra-articular injection drug products targeting osteoarthritis — requires pharmaceutical-grade specification as the starting material.
Reference-grade material for formulation development, stability studies, and clinical trial manufacturing — full regulatory support documentation available.
GRAS, fermentation-derived — for dietary supplements and functional foods.
Learn More →Endotoxin-controlled (< 0.5 IU/mg) — for artificial tears and eye-drop solutions.
Learn More →Ultra-high purity — for dermal fillers and intra-articular injections.
Learn More →Contact us for batch COA, Ph.Eur. compliance documentation, DMF support, and pricing based on your required MW grade and volume.