AOAC SPIFAN Stakeholder Panel Meeting Book (March 12, 2020)

2. Analytical method variability SPIFAN methods

• Mean RSD R values calculated from MLT for matrices within ±25% of midpoint regulatory requirements. Degrees of freedom for each matrix taken into account to calculate SD R . • All RSD R

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3. Definition of Method Capability ( C m )

=

6 × SD

C p =1: 0.27% of products out of specification (99% CI)

=

6 × SD

• SD < SD • Variance analytical method considered 1/3 of process variance • = × = 1.73 • <1.73 problem to achieve =1, <1 critical

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