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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