Formulae for maximum valid dilution.
The preparation of test specimens using the MVD calculation represents a reasonable approach to equating the sensitivity of the in vitro and in vivo tests for endotoxin. Labeling of LAL reagents and control standard endotoxins are a point of confusion for the parenterals industry. Government and reagent suppliers must work together expeditiously to provide test materials that are explicitly labeled as to reactivity in EU/ml and ng/ml. The relatively greater reactivity of LAL reagent to environmental endotoxin than the rabbit bioassay provides a greater margin of safety for the in vitro approach than previously anticipated, and suggests that rabbit retest of LAL failures may be appropriate for specific products.
D000818:Animals; D001681:Biological Assay; D004305:Dose-Response Relationship, Drug; D004731:Endotoxins / Q000032:analysis*; D006801:Humans; D008033:Limulus Test; D010602:Pharmacopoeias as Topic; D011786:Quality Control; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration
D004731:Endotoxins