88 / 159
FOR EXPERT REVIEW PANEL USE
ONLY NOT FOR DISTRIBUTION
3
Precision (RSD
r
):
SMPR 2012.013:
≤ 10% @ 2 mg/100g as RTF / reconstituted powder
≤ 5% @ 20 - 200 mg/100g as RTF / reconstituted
powder
Validation report: All 17 SPIFAN matrices were run over at least 4 days in triplicate. New working
standards were prepared each day. Each sample was analyzed by at least 2 analysts, on 2
instruments, and 2 columns. “Results that calculated to be outliers based on a 95% confidence
interval using Grubb’s outlier test were replaced with re-analysis to obtain 12 data points overall
for each product.”
15 of the 17 matrices produced results for total choline within the analytical range of the
method. The range of RDSr values was 1.2% - 3.4% (Table 14).
Reproducibility (RSD
R
):
SMPR 2012.013:
≤ 15% @ 2 mg/100g as RTF / reconstituted powder
≤ 10% @ 20 - 200 mg/100g as RTF / reconstituted
powder
•
System suitability:
The method does not describe the exact sequence of calibrants and unknowns to be injected, the
requirement for the linearity of the calibration curve, the requirement for the reproducibility of any
standard readbacks, or the agreement required between the results from quantitative and
confirmatory transitions.
Recommendation:
Approve as First Action.
Chol-08 Review Forms