Items | Standard |
Appearance | White or almost white powder or fibrous aggregate |
Identification A.Infrared absorption B.Reaction of sodium |
The IR spectrum of the sample exhibits maxima at the same wavelength as that of Ph.Eur.reference spectrum of Sodium Hyaluronate Positive |
Appearance of solution | Clear and the absorbance is NMT 0.01 at 600 nm |
pH | 5.0~8.5(0.5%solution) |
Intrinsic viscosity | 2.0 m³/kg~2.6 m³/kg |
Molecular weight | 1.20×10⁶Da~1.60×10⁶Da |
Nucleic acids | The absorbance is NMT 0.5 at 260 nm |
Protein | ≤0.1%(on the dried substance) |
Chlorides | ≤0.5% |
Iron | ≤80 ppm (on the dried substance) |
Loss on drying | ≤15.0% |
Assay | 95.0%~105.0%(on the dried substance) |
Residual solvents:Ethanol | ≤0.5% |
Microbial contamination-TAMC | ≤100 cfu/g |
Bacterial endotoxins | <0.5 IU/mg |