Chondroitin Sulfate 90% (Bovine)
Ville: LV, Marupe
Physical & Chemical Characteristics
Analysis Item | Specification | Result |
Appearance | Off white to cream powder | Off white to cream powder |
Identification | Meet the requirements | Meet the requirements |
Assay | ≥90.0>#/span### | 91.1>#/span### |
Loss on drying (105°C, 4 h) | ≤10.0>#/span### | 8.8>#/span### |
Residue on ignition (on dried basis) | 20.0–30.0>#/span### | 24.1>#/span### |
Specific rotation | -20° to -30° | -21.9° |
pH | 5.5–7.5 | 6.5 |
Protein | ≤6.0>#/span### | 4.5>#/span### |
Electrophoretic purity | ≤2>#/span### | <2>#/span### |
Bulk Density | ≥0.48 g/ml | 0.55 g/ml |
Tapped Density | ≥0.70 g/ml | 0.86 g/ml |
Particle Size | 100% through 60 mesh | 100% through 60 mesh |
Heavy Metals
Analysis Item | Specification | Result |
Heavy Metals (total) | ≤20 ppm | <20 ppm |
Arsenic (As) | ≤1.5 ppm | <1.5 ppm |
Lead (Pb) | ≤0.5 ppm | <0.5 ppm |
Cadmium (Cd) | ≤0.5 ppm | <0.5 ppm |
Mercury (Hg) | ≤1.5 ppm | <1.5 ppm |
Microbiological Tests
Analysis Item | Specification | Result |
Total Plate Count | ≤1000 cfu/g | <1000 cfu/g |
Yeasts & Molds | ≤100 cfu/g | <100 cfu/g |
E. coli | Negative/g | Negative/g |
Salmonella | Negative/10 g | Negative/10 g |
Staphylococcus | Negative/g | Negative/g |
Conclusion
Analysis Item | Specification | Result |
Conclusion | Comply with current USP standards | Complies |