|Characters-Appearance||White or almost white, very hygroscopic powder or fibrous aggregate.||White or almost white, very hygroscopic powder or fibrous aggregate.|
|Characters-Solubility||Sparingly soluble or soluble in water, practically insoluble in acetone and in anhydrous ethanol.||Sparingly soluble or soluble in water, practically insoluble in acetone and in anhydrous ethanol.|
|Identification A (IR)||Examine by infrared absorption spectrophotometry, comparing with the Ph. Eur. Reference spectrum of sodium hyaluronate||Examine by infrared absorption spectrophotometry, comparing with the Ph. Eur. Reference spectrum of sodium hyaluronate|
|Identification B (Na+)||It gives reaction (a) of sodium||It gives reaction (a) of sodium|
|Appearance of Solution||Solution S is clear, and its absorbance at 600 nm is maximum 0.01||Solution S is clear, and its absorbance at 600 nm is maximum 0.01|
|pH||5.5 - 7.0||5.0 - 8.5|
|Intrinsic Viscosity||1.3 - 3.0 m3/kg||90 - 120 % of the value stated on the label|
|Nucleic Acid||Absorbance of solution S at 260 nm is maximum 0.1||Absorbance of solution S at 260 nm is maximum 0.5|
|Protein||≤ 0.1 %||≤ 0.3 %
≤ 0.1 %*2
|Chlorides||≤ 0.1 %||≤ 0.5 %|
|Iron||≤ 20 ppm||≤ 80 ppm|
|Heavy Metals||≤ 10 ppm||≤ N/A*5|
|Loss on Drying||≤ 10.0 %||≤ 20.0 %|
|Assay||95.0 - 105.0 %||95.0 - 105.0 %|
|Microbial Limit Test||TAMC: ≤ 102 CFU/g
TYMC: ≤ 102 CFU/g
|TAMC: ≤ 102 CFU/g|
|Bacterial Endotoxins||< 0.04 IU/mg||< 0.5 IU/mg*3
< 0.05 IU/mg*4
|Residual solvents||Ethanol: ≤ 10,000 ppm
Methanol: ≤ 3,000 ppm
|Sulphated glycosaminoglycans*1||N/A||≤ 1 %|
Shiseido Sodium Hyaluronate has been used in a wide range of pharmaceutical products and medical devices in the following fields:
The production is based on the fermentation technology with Streptococcus, Lancefield Group C, one of the naturally occurring lactic bacteria, and it does not involve Genetically Modified Organism (non-GMO).
In addition, we tightly control bacteria generation by limiting the number of generations of bacteria used for manufacture.
Sodium hyaluronate is temperature sensitive, and thus temperature control is a very important factor for quality during delivery. With much experience and research in this area, we are able to propose various delivery conditions based on your needs. Please feel free to contact us for more information.
|Available package size||10g, 100g|
|Primary container||Polypropylene bottle|
|Secondary container||Heat-sealed aluminium bag|
|Label||Affixed to both primary and secondary containers|
Shiseido Sodium Hyaluronate is manufactured in our dedicated plants in Japan, which are designed in compliance with GMP of Japan, Europe, the United States, South Korea, and India.
Since we began operations in 1984, we have been constantly expanding our manufacturing capabilities. In 2018, we started manufacturing Sodium Hyaluronate at our new plant, which is located at the same manufacturing site.
Kakegawa Factory, 1120 Nagaya Kakegawa, Shizuoka, 436-0047, Japan
Manufacturing plants dedicated for Shiseido Sodium Hyaluronate