Associates of Cape Cod, Inc.
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LAL Update Newsletter
CURRENT ISSUE:
Controls for Photometric Tests: Implications for Low Capacity Test Systems
VOL. 25, NO. 1 Download (216K PDF)
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Letter From The Editor
Dear LAL User:The bacterial endotoxins test chapters in the United States, European and Japanese pharmacopeia specify particular controls for the test. Consequently, a minimum number of samples (i.e. reaction tubes, wells or channels) is needed in order to run tests that are compliant with the pharmacopeia. This LAL Update looks at the impact of the pharmacopeial requirements upon the minimum sample capacity of test systems used for photometric tests.
While not addressed in the pharmacopeia, the FDA guidance documents on LAL testing provide for use of archived standard curves, provided that certain prerequisites are met and that appropriate controls are included in tests that use archived curves to determine endotoxin concentrations. The implications of these provisions on test systems are also discussed.
We hope that those users in the Northern hemisphere are enjoying a pleasant spring and that those of you south of the equator had a good summer.
With best wishes,
Michael Dawson, Ph.D., RAC