Compliant with EP 11.0 standards for parenteral applications. Actual batch COA provided upon inquiry.
| 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 |
Injectable grade represents the strictest purity specification for chondroitin sulfate — meeting EP 11.0 standard for parenteral application starting materials.
The strictest endotoxin limit across all CS grades — tested by LAL method per EP 2.6.14, ensuring safety for intra-articular and parenteral applications.
Minimizes immunogenic risk in injectable formulations — critical for patient safety in intra-articular injection drug products.
Total Plate Count ≤ 100 CFU/g, Molds ≤ 50 CFU/g — providing minimal bioburden for subsequent aseptic processing steps.
Bovine source with complete TSE risk assessment, raw material traceability, and supplier audit documentation for Class III medical device submissions.
COA per batch, endotoxin test report, electrophoretogram, GMP certificate, BSE/TSE declaration, and MSDS available for regulatory filings.
Pharmacopoeia grade Chondroitin Sulfate for parenteral drug products and sterile Class III medical devices.
The primary injectable CS application — viscosupplementation drug products for osteoarthritis treatment injected directly into the joints.
Class III injectable medical devices requiring EP-grade starting materials with documented endotoxin control and full supply chain traceability.
Co-formulated with injectable-grade hyaluronic acid in combination viscosupplementation products for enhanced joint lubrication.
Starting material for parenteral formulation development, stability studies, and clinical trial manufacturing of injectable joint therapy products.
EP compliant grade for oral drug products and medical device applications.
Learn More →Ultra-pure sterile Sodium Hyaluronate for joint injections and dermal fillers.
Learn More →High-quality bovine source material with documented purity and origin.
Learn More →Contact our parenteral product specialists to receive technical dossiers, endotoxin reports, and samples for your injectable product development.