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FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
2
General Comment:
•
Generally, set-up seems suitable for SLV
•
As only four of the SPIFAN matrices contained FOS, the number of tested matrices for precision is
rather limited
•
Performance Characteristics:
Analytical Range: 0.03 – 5 %
LOQ: 0.03 %
Accuracy/Recovery: average 100%; recoveries are well within 90 – 110% range
Precision (RSD
r
): average 6.3%; 2 out of 4 are outside acceptability limit
Reproducibility (RSD
R
): average 7.1%; within acceptability limits
•
System suitability: ok
Recommendation:
Although the precision results are just outside the acceptability limits, we recommend this method for First
Action approval if clarity is given around the calculation of DP.
FOS-01 Review Forms