AI Article Synopsis
- The Limulus amebocyte lysate assay was used to detect bacterial endotoxin in various chemotherapeutic agents, confirming the presence of endotoxin in some drugs at concentrations between 0.1 to 63 ng/ml.
- Multiple lots of certain drugs showed variability, with about half of them having endotoxin levels below detectable limits (<0.1 ng/ml).
- The Limulus test is highlighted as an effective method for quickly identifying endotoxin contamination in injectable antitumor medications.
Article Abstract
The Limulus amebocyte lysate assay was used to detect the presence of bacterial endotoxin in a variety of chemotherapeutic agents currently in use. Results were quantitated using a standard Escherichia coli endotoxin curve. Relative concentrations of endotoxin ranging from 0.1 to 63 ng/ml were detected in individual lots of L-asparaginase, 5-azacytidine, bleomycin, DTIC, actinomycin D, adriamycin, and vinblastine diluted to normal concentrations for injection. When multiple lots of a given drug were tested, at least one lot produced a negative assay, indicating less than 0.1 ng/ml of endotoxin in 50% of these drugs. All lots of cytosine arabinoside, cyclophosphamide, daunorubicin, vincristine, and streptozotocin tested had less than 0.1 ng/ml of endotoxin. Inactivation kinetics of the Limulus-positive drug material in dilute alkali solutions were identical to those of E. coli endotoxin. The Limulus lysate test is a rapid and specific method for the detection of small amounts of bacterial endotoxin contaminating parenteral preparations of antitumor agents.
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