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Together with the sensitivity on the examination, better numbers of dosage units/products might be tested using LAL. By way of example, a sterile important unit was observed to possess a suitable endotoxin degree from the pooled sample. (Note: The USP pyrogen take a look at is carried out with a pooled sample.) Even so, when extracts of models have been LAL tested separately, occasional failures have been noted.
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There have been considerable discussion within the literature just lately pertaining to the Bacterial Endotoxins Examination, its importance and interpretation, and its comparison to your USP rabbit exam.
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Some companies have occasionally resorted to less suitable strategies such as washing or rinsing the crystal or powder that has a solvent in an effort to remove endotoxins.}