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FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
3
≤ 1.0 mcg/100g RTF 4.67 %
Intermediated Precision:
1-100 mcg/100g RTF - 4.29 – 10.29 %
≤ 1.0 mcg/100g RTF 7.73 %
System suitability:
Correlation of standard curves must be greater than 0.999 and standard response (drift) of not more than
10%. This is a bit high, suggest it should be no more than 3 %. Slope accuracy could be used instead of
standard area to assess drift.
Suggest adding a peak resolution solution as fairly critical for this assay – 5 peaks of interest and depending
on sample matrix, some very close to interfering peaks.
Recommendation:
Recommend to be considered for First Action and MLT Study