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FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
2
Cons/Weaknesses
•
High RSDs.
Supporting Data
•
General Comment:
-
Method Optimization:
•
Performance Characteristics:
Analytical Range:
LOQ:
Accuracy/Recovery:
Precision (RSD
r
):
Reproducibility (RSD
R
):
Many of the elements fail to meet SMPR requirements in several products. Calcium had >10% RSD
on several products that would be high level
•
System suitability:
Recommendation:
Method does not go to final action based on data generated.