FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
2
Just outside the range specified in SMPR
LOQ:
~0.8 mcg/100g in reconstituted powder product
Just outside the range specified in SMPR
Accuracy/Recovery:
95-111% acceptable recovery
% bias against NIST 1849a, within acceptable limits
Precision (RSD
r
):
0.5-3.0% within limits specified in SMPR
Reproducibility (RSD
R
):
System suitability:
“Suitable methods will include blank check samples, and check standards at the lowest point and midrange
point of the analytical range.”
Recommendation:
Recommended First Action
Bio-03 Review Forms