MICROBIAL SOLUTIONS Endotoxin Calculations and Validations ...
, EP 2.6.14, and ANSI/AAMI ST72:2019 all suggest the pH of equal parts sample and lysate mixture should be tested. LAL offers some buffering capacity, therefore a pH adjustment may not be necessary. If the pH of a sample does not need to be adjusted during validation, the pH does not need to be measured for each lot of product during subsequent ................
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