B. Renger, System performance and variability of chromatographic techniques used in pharmaceutical quality control, J CHROMAT B, 745(1), 2000, pp. 167-176
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.