Sodium Hyaluronate
Sodium Hyaluronate is known as humectant, lubricant, sustained-release agent. This product is available in Arvin Kala’s diverse product portfolio.
Description
The European Pharmacopoeia (PhEur) 6.3 defines sodium hyaluronate as the sodium salt derived from hyaluronic acid, which is a glycosaminoglycan composed of disaccharide units of D-glucuronic acid and N-acetyl-D-glucosamine. Sodium hyaluronate appears as a white to off-white powder or granules and is highly hygroscopic.
Applications in Pharmaceutical Formulation or Technology

At physiological pH, sodium hyaluronate is the main form of hyaluronic acid. The term “hyaluronan” is used to refer to the polysaccharide in general, and in literature, “hyaluronic acid” and “sodium hyaluronate” are often used interchangeably.
Hyaluronan is therapeutically used to treat knee osteoarthritis and is effective in alleviating arthritic pain. Crosslinked hyaluronan gels are utilized as drug delivery systems.
Hyaluronan is the most prevalent negatively charged glycosaminoglycan in the human vitreous humor and is known to interact with polymeric and liposomal DNA complexes. Hyaluronan solutions have been shown to reduce the cellular uptake of these complexes, which is beneficial for increasing the availability and retention time of drugs administered to the eye. Being immunoneutral, hyaluronan is valuable for attaching biomaterials used in tissue engineering and drug delivery systems. It also has significant applications in vascular surgery and vascular supplementation.

Stability and Storage Conditions
Sodium hyaluronate should be kept in a cool, dry environment within tightly sealed containers. The powder remains stable for up to three years if stored in unopened containers.
Method of Manufacture
Sodium hyaluronate is naturally found in vitreous humor, serum, chicken combs, shark skin, and whale cartilage. It is typically extracted and purified from chicken combs. Alternatively, it can be produced through the fermentation of selected Streptococcus zooepidemicus bacterial strains. The sodium hyaluronate is then separated from the fermentation medium by filtration, purified via ultrafiltration, precipitated with an organic solvent, and dried.
Safety
Sodium hyaluronate is utilized in cosmetics as well as in topical, parenteral, and ophthalmic pharmaceutical formulations. It is generally considered to be relatively nontoxic and nonirritating. However, sodium hyaluronate has been reported to be an experimental teratogen.

LD_(50 ) (mouse, IP): 1.5 g/kg
LD_(50 ) (rabbit, IP): 1.82 g/kg
LD_(50 ) (rat, IP): 1.77 g/kg

Handling Precautions

Take standard precautions suitable for the specific circumstances and quantity of material being handled. When sodium hyaluronate is heated to decomposition, it releases toxic fumes of Naâ‚‚O.

Chemical-physical values

Test Item Unit Specification
Hg
mg/kg
NMT 0.5
Cd
mg/kg
NMT 0.5
Heavy metal(in lead)
mg/kg
NMT 10
Protein content
%
NMT 10
Total colony number
Cfu/g
NMT 100
Fungi and yeasts
Cfu/g
NMT 50
Escherichia Coli
Negative
Coliforms
Negative
Staphylococcus aureus
Negative
Pseudomonas Aeruginosas
Negative
Test Item Unit Specification
Appearance
White powder or granules
Glucuronic acid content
%
NLT 45.0
Sodium hyaluronate content
%
NLT 95.0
Absorbance
NMT 0.25
Transparency
NLT 99.0
Intrinsic viscosity value
NLT 4.91 NMT 8.43
Dry weight loss
%
NMT 10.0
pH
NLT 5.0 NMT 8.5
Pb
mg/kg
NMT 2
As
mg/kg
NMT 1

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