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FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
2
SPIFAN kit (1) used in the validation of the method.
Performance Characteristics:
Analytical Range:
0.03g to 5g/100g
LOQ:
0.03g/100g
Accuracy/Recovery:
Spike recovery of 100.3% (96.9% -107.1%)within SMPR limits
Precision (RSD
r
):
6% RSDr( 3.2-9.5%), partially (2.4 reported results) meets SMPR
Reproducibility (RSD
R
):
System suitability:
No details
Recommendation:
TBD
FOS-01 Review Forms