USP <797> <85>
At CIAL, we have two methods of testing for Bacterial Endotoxins per USP <85>. The majority of samples coming in for endotoxin testing will be tested using a Turbidimetric method. This technology will allow us to test to a sensitivity of 0.001 EU/mL if necessary. We may use Gel-Clot method where needed if there are too many interfering factors for a valid result using the Turbidimetric Method. Samples tested by Gel-Clot will be reported on a Pass/Fail basis determined by the limit of the sample. All samples are treated with a beta-glucan inhibitor to prevent any false-positives.
Customers can expect to receive their Endotoxin test results along with the Sterility results or within one week of receipt of sample.