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In addition to the sensitivity on the exam, greater numbers of dosage units/units could be tested employing LAL. For instance, a sterile critical device was uncovered to acquire a suitable endotoxin stage from a pooled sample. (Be aware: The USP pyrogen examination is performed over a pooled sample.) Nevertheless, when extracts of models have been LAL analyzed individually, occasional failures were noted.
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The examination is inadequate for certain classes of prescription drugs which include radiopharmaceuticals, most cancers chemotherapeutic agents, hypnotics and narcotics, natural vitamins, steroids and sure antibiotics. It has been observed that evident pyrogens while in the solution is often "masked" via the physio-chemical exercise with the therapeutic drug elements. Also, the rabbit exam is insufficiently delicate for endotoxin detection in intrathecal drug solutions.
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The precise mechanism of this phenomenon, termed endotoxin tolerance, is unfamiliar". Also, some scientific tests have revealed the endotoxin with the Legionnaires' bacillus has another spectrum of toxicity than the greater widespread gram-destructive organisms. Especially the Legionnaires' endotoxin wasn't really pyrogenic (with the rabbit examination), but was really active in the LAL - 1,000 fold distinction between the two exams. In this situation, the rabbit take a look at is insufficient for pinpointing the potency of the toxins existing.
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