Pharmacopoeia-grade parameters for bovine-derived Chondroitin Sulfate Sodium. Full regulatory support provided.
| Test Item | Result / Specification |
|---|---|
| Identification & Appearance | |
| Appearance | White to off-white free flowing powder |
| Particle Size | 100% pass 80 mesh |
| Identification A (IR) | Conforms to reference standard |
| Identification B (Na) | Positive sodium salt reaction |
| Identification C (Electrophoretogram) | Conforms |
| Clarity (5% solution) | Absorbance ≤ 0.35 |
| Chemical Assay | |
| Assay (CPC, dried basis) | 95.0% – 105.0% |
| Electrophoretic Purity | Individual impurity ≤ 2% |
| Specific Rotation | -20.0° to -30.0° |
| Physical & Chemical | |
| pH (1% solution) | 5.5 – 7.5 |
| Loss on Drying | ≤ 12.0% |
| Protein (dried basis) | ≤ 3.0% |
| Chloride | ≤ 0.50% |
| Sulfate | ≤ 0.24% |
| Residue on Ignition | 20.0% – 30.0% |
| Microbiological & Endotoxin | |
| Total Plate Count | ≤ 100 CFU/g |
| Yeasts & Molds | ≤ 50 CFU/g |
| E. coli | Negative |
| Salmonella | Negative |
| Pseudomonas aeruginosa | Negative |
| Bacterial Endotoxins | < 0.05 EU/mg |
| Packaging & Storage | |
| Packaging | 1 kg / 5 kg |
| Storage | Cool, dry, away from light |
| Shelf Life | 24 months |
Manufactured and tested to European Pharmacopoeia 11.0 corporate internal control standard — the international gold standard for pharmaceutical-grade chondroitin sulfate.
Bacterial endotoxin tested by LAL method (< 0.05 EU/mg) — meeting the strict threshold required for pharmaceutical drug product applications and medical device starting materials.
Assay range 95.0–105.0% (vs 90–105% for food grade) with protein ≤ 3.0% (vs ≤ 6.0%) — significantly tighter purity controls for pharmaceutical applications.
Total Plate Count ≤ 100 CFU/g, Molds ≤ 50 CFU/g, plus Pseudomonas aeruginosa testing — meeting pharmaceutical ingredient microbiological requirements.
Pharmaceutical-grade bovine source with complete BSE/TSE risk assessment documentation and full raw material traceability for regulatory dossiers.
COA, TDS, MSDS, endotoxin test report, electrophoretogram, and GMP certificate available to support IND, NDA, and CE marking submissions.
Pharmacopoeia grade Chondroitin Sulfate for drug formulation, medical devices, and high-end clinical research.
Oral pharmaceutical formulations for joint health drug registration — required in markets where CS is classified as a drug.
Starting material for Class II/III medical devices including injectable joint therapies, anti-adhesion barriers, and orthopedic device coatings.
Reference-grade material for clinical trial manufacturing and formulation development requiring documented pharmacopoeia compliance.
High-purity pharmaceutical-grade CS as the starting material for further purification to injectable grade for viscosupplementation drug products.
Ultra-pure, endotoxin-tested grade for intra-articular injection applications.
Learn More →Ph.Eur./USP compliant Sodium Hyaluronate for pharmaceutical applications.
Learn More →High-quality bovine source material with documented purity and origin.
Learn More →Contact our pharmaceutical specialists to receive technical dossiers, GMP certificates, and samples for your regulatory submissions.