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Notice on the adjustment of labeling method of bacterial endotoxin working products


Dear customers

For a long time, our company's bacterial endotoxin working standards have been labeled according to the fixed titer, such as 10EU / tube. This labeling method has its unscientific nature and defects: it reduces the accuracy of the test. As a biological product, the rate of bacterial endotoxin production is fluctuating within a certain range, and it is difficult to fix it to a point. Secondly, the gel method shows the breakpoint jumping instead of continuous. Third, our work also needs to be standardized with the standard of the Central Inspection Institute, and the three fixed factors are not scientific. There is a long-term error between the working products of bacterial endotoxin and the real value, which also causes great trouble and inconvenience to our work, and brings great pressure to the after-sales service.

In order to ensure the accuracy of the experiment and product safety, we learn from the method of CFDA, and take the objective, true and accurate as the first principle. After completing the potency calibration test of bacterial endotoxin working standard, the comprehensive statistics are indicated according to the statistical value (true potency), and no longer deliberately pursue the specific marked value, such as 10EU / tube. Of course, in order to facilitate your work, we will control the potency in the range of 5-20EU / tube.

The above changes need to be informed in advance for everyone to prepare. Please understand the inconvenience caused to you! The pursuit of higher accuracy is our consistent goal.

This change will be implemented from May 1, 2021.