Sodium Hyaluronate
Topical Grade (CEP-DMF)
CAS #:
9067-32-7
Molecular Formula:
(C14H20NO11Na)n
Synonym:
Hyaluronic Acid Sodium Salt, Sodium Hyaluronate, Hyalurone sodium
Molecular Weight:
799.64 g/mol
Overview
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:
- Keep container tightly closed in a cool, well- ventilated place away from heat, UV light and humidity.
- Keep away from oxidising agents and substances harmful or toxic to the environment.
- Recommended storage temperature: 2-8° C for long term.
Pack Sizes: 25 gm
