Skip to main content

Table 2 Major model regression statistics of various chromatographic responses

From: Perspectives in modeling and model validation during analytical quality by design chromatographic method evaluation: a case study

Response MSR MSR adjusted MSR threshold MS-LOF MS-LOF threshold
API area (default) 0.9913 0.9906 0.0022 0.0006 0.0041
Epimer area (default) 0.9902 0.9895 0.0024 0.0008 0.0026
API area (customer) 0.8191 0.8124 0.0282 0.0081 0.0026
Epimer area (customer) 0.8481 0.8425 0.0237 0.0068 0.0017
API plate count 0.9101 0.8906 0.0516 0.0206 0.0716
API RT (min) 0.9988 0.9984 0.0009 0.0003 0.0028
Epimer RT (min) 0.9986 0.9982 0.0009 0.0004 0.0014
Impurity 2 RT (min) 0.9988 0.9986 0.0006 0.0002 0.0014
Impurity 3 RT (min) 0.9983 0.9979 0.0011 0.0004 0.0022
# of peaks 0.8582 0.8356 0.0626 0.0250 0.0613
# of peaks with ≥ 1.5 — resolution 0.7928 0.7889 0.0711 0.0275 0.0400
API plate count Cpk 0.9949 0.9924 0.0059 N/A N/A
# of peaks with ≥ 1.5 — resolution Cpk 0.9999 0.9999 0.0001 N/A N/A