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. | |
Solubility | Sparingly soluble or soluble in water, practically insoluble in acetone and in anhydrous ethanol. | |
Identification | ||
A. Infrared absorption | The IR absorption spectrum of the sample must be concordant with the spectrum obtained from sodium hyaluronate Reference standard. | |
B. Reaction of sodium | It gives reaction (a) of Sodium. | |
Appearance of solution | Solution S should be clear and its absorbance at 600 nm should not be greater than 0.01. | |
pH | Between 5.5 to 7.0 (0.5% solution) | |
Intrinsic viscosity | m3/kg | 1.4 ~ 1.5 |
Nucleic acids | Absorbance of solution S at 260 nm should be maximum 0.1. | |
Protein | % | ≤ 0.1 % (on the dried substance) |
Chlorides | % | ≤ 0.1 |
Heavy metals | ppm | ≤ 10 ppm |
Iron | ppm | ≤ 20 ppm (on the dried substance) |
Loss on drying | % | ≤ 10.0 |
Assay | % | 95.0% ~105.0% (on the dried substance) |
Residual solvents: Ethanol | % | ≤ 1.0% |
Microbial limit test | ||
Total aerobic microbial count | cfu/g | ≤ 100 |
Total yeast and mould count | cfu/g | ≤ 100 |
Shelf Life/Retest Date: Sodium Hyaluronate (Topical Grade) can be kept for at least 2 years if stored under recommended conditions.
Storage/Shipping Conditions:
Pack Sizes: 25 gm