Items | Specification |
Origin | Healthy Bovine Cartilage |
Appearance | White or almost white, hygroscopic powder |
Solubility | Freely soluble in water, practically insoluble in acetone and in ethanol (96%) |
Identification | Infrared absorption spectrophotometry | Meets the requirements |
Reaction (b) of sodium | Meets the requirements |
Electropherograms | The principal band in the electropherogram obtained with the test solution is similar in position to the principal band in the electropherogram obtained with reference solution (a) |
pH (5% solution w/v) | 5.5~7.5 |
Specific Optical Rotation (dried substance) | -20° ~ -30° |
Intrinsic Viscosity | 0.01 m3/kg ~ 0.15 m3/kg |
Related Substances | ≤ 2% |
Protein (dried substance) | ≤ 3.0% |
Chlorides | ≤ 0.5% |
Loss on Drying | ≤ 12.0% |
Residual Ethanol | ≤ 5000 ppm |
Assay (CPC method) | 95% ~ 105% (dried substance) |
TAMC | ≤ 1000 CFU/g |
TYMC | ≤ 100 CFU/g |
Escherichia coli | Absence/g |
Salmonella | Absence/10 g |
Staphylococcus aureus | Absence/g |
Pseudomonas aeruginosa | Absence/g |
Bile-tolerant gram-negative bacteria | Absence/g |
Standard | EP11.0 |