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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