System performance and variability of chromatographic techniques used in pharmaceutical quality control

Data representing the routine performance of different chromatographic equi pment systems used in pharmaceutical quality control are presented. These p erformance data allow one to predict long-term relative uncertainties and c onfidence intervals for different chromatographic procedures and techniques . From the variability that is to be expected, it is apparent that many chr omatographic procedures run as routine applications in the pharmaceutical i ndustry are unlikely to be capable of controlling the tight specification l imits like those usually demanded for bulk drug substances (active pharmace utical ingredients), the European 95-105% expectation for finished drugs, o r to be used in stability studies. (C) 2000 Elsevier Science B.V. All right s reserved.