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

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