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A multi-company investigation is presented to obtain and compare precision results for LC assay procedures. Forty-four drug substances and drug products of various types subjected to 156 stability studies, with 2915 assay values in total, were included. This provides an excellent source of real long-term precision estimates, as the same analytical procedure(More)
Although a generally accepted procedure has now been established for the organizational handling of out-of-specification test results, the uncertainty surrounding their statistical evaluation persists. Two statistical equations, the prediction and the confidence interval, are sufficient to examine whether data numbers indicate out-of-specification (OOS)(More)
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