Technical Barrier of Sodium Hyaluronate Pharma Grade: "Bacterial Endotoxins "
The bacterial endotoxins level of Topscience is around 0.001 IU/mg, which was 50 times lower than that specified in Ph. Eur. For bacterial endotoxins control of Sodium Hyaluronate, Topscience is in the leading position in the industry.
Bacterial endotoxins, also known as
lipopolysaccharide, is the main structure of the outer membrane of
Gram-negative bacteria. It will fall off from the outer membrane of bacteria
and be released into the surrounding media during the various stages of
bacterial growth and reproduction as well as when the bacteria are autolyzed or
lysed.
Topscience has been working on lower levels of bacterial endotoxins. According to the bacterial endotoxins test results of Sodium Hyaluronate in successive batches, the bacterial endotoxins level of Topscience is around 0.001 IU/mg
Topscience has now upgraded the in-house quality standard of Sodium Hyaluronate injection grade, and the upper limit of bacterial endotoxins has been updated to 0.005 IU/mg, which confirms the high-quality assurance of Topscience.
The level of bacterial endotoxin of Topscience is 50 times lower than the standard that specified in Ph. Eur. which is due to the strict and efficient control of the product quality from the collection of raw materials to products release. Topscience' Sodium Hyaluronate is produced by microbial fermentation without any raw material from animal, and exellent impurity control including bacterial endotoxin, heavy metal, elemental impurity, microbial contamination, etc.,
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