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FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
2
1.
Precision data were generated with all SPIFAN I matrices. Accuracy (spike recovery) data were
generated with 1 fortified and 4 placebo SPIFAN I matrices.
2.
10 of the SPIFAN matrices were analyzed with immunoaffinity columns from two different
manufacturers, EASI-EXTRACT (Biopharm) and BioTeZ IAC (Biotez)
3.
Representative chromatograms provided.
-
Method Optimization:
•
Performance Characteristics:
Analytical Range: 0.1-300 µg/100g. SMPR = 0.1-150 µg/100g
LOQ: Estimated to be 0.1 µg/100g. SMPR <0.1 µg/100g.
Accuracy/Recovery:
Results for SRM 1849a are within the certified range.
Spike recoveries range from 95-105%. SMPR 90-110%
Precision (RSD
r
): Repeatability was not calculated. Overall RSD of all results ranged from 0.55-
3.19%. SMPR repeatability <6%.
Reproducibility (RSD
R
): NAP
•
System suitability: No system suitability requirements listed, but authors noted that during the SLV, r
2
was not less than 0.998.
Recommendation:
All of the data from analyses of SPIFAN matrices met the SMPR requirements. I would recommend this
method for first action status.
Bio-02 Review Forms