Purified Sodium Hyaluronate occurs as white powder, granules or as fibrous masses. It is sparingly soluble in water and practically insoluble in ethanol.
Characters | Unit | Specification |
---|---|---|
Appearance | White or almost white, very hygroscopic powder or fibrous aggregate. | |
Identification | ||
A. Infrared absorption | Complies with Ph. Eur. reference spectrum of Sodium Hyaluronate | |
B. Reaction of sodium | Positive | |
Appearance of solution | Clear and the absorbance is NMT 0.001 at 600nm | |
pH | Between 5.0 to 8.5 (0.5% solution) | |
Intrinsic viscosity | Report the test value | |
Molecular weight | Report the test value | |
Nucleic acids | The absorbance is NMT 0.5 at 260 nm | |
Protein | % | ≤ 0.1 % (on the dried substance) |
Chlorides | % | ≤ 0.5 |
Heavy metals | ppm | ≤ 10 ppm |
Iron | ppm | ≤ 80 ppm (on the dried substance) |
Loss on drying | % | ≤ 10.0 |
Assay | % | 95.0% ~105.0% (on the dried substance) |
Residual solvents: Ethanol | % | ≤ 0.5 |
Microbial contamination | cfu/g | ≤ 100 |
Bacterial Endotoxins | IU/mg | ≤ 0.05 |
Shelf Life/Retest Date: : Sodium Hyaluronate (Injection Grade) can be kept for at least 2 years if stored under recommended conditions.
Storage/Shipping Conditions:
Pack Sizes: 25 gm