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FOR EXPERT REVIEW PANEL USE ONLY

NOT FOR DISTRIBUTION

2

Performance Characteristics:

The study director has made an error in the evaluation of bias against the NIST by reporting the wrong

certified value for NIST 1849a. The method actually shows no bias against the NIST value when using the

correct value.

Analytical Range:

0.05-10 meets SMPR limits (0.12-5.1 µg/100g)

LOQ:

4.58 ng/100g meets SMPR limits (<0.12 µg/100g)

Accuracy/Recovery:

103% average (101-103%) meets SMPR limits (90-110%).

Acceptable bias against NIST1849a SMPR

Precision (RSD

r

):

2.3% meets SMPR limits (<11%)

Reproducibility (RSD

R

):

System suitability:

No details

Recommendation:

Not recommended First Action at this time.

VitD-17 Review Forms