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

Data representing the routine performance of different chromatographic equipment systems used in pharmaceutical quality control are presented. These performance data allow one to predict long-term relative uncertainties and confidence intervals for different chromatographic procedures and techniques. From the variability that is to be expected, it is apparent that many chromatographic procedures run as routine applications in the pharmaceutical industry are unlikely to be capable of controlling the tight specification limits like those usually demanded for bulk drug substances (active pharmaceutical ingredients), the European 95–105% expectation for finished drugs, or to be used in stability studies.