51 / 65
FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
(DRM)
2
After removal of outliers repeatability and reproducibility met the SMPR for all matrices
except the Adult Nutritional RTF High Fat Placebo and the Child Formula Powder Milk
Based Placebo; however, method meet SMPR in the fortified versions of these matrices.
Did Method Author Consider ERP’s Method Specific Recommendations (See web link to specific method
comments):
Any Revision to Method Scope/Applicability of Method:
No.
General comments (i.e. safety) about the method:
Feedback from Users of the Methods since being awarded First Action
Official Methods
Status
No user comments reported.
Additional Pros/Strengths:
Method is clearly written, easy to follow, and easy to perform. After the removal of
outliers, repeatability and reproducibility data very good.
Additional Cons/Weaknesses /Concerns
With the SPIFAN matrices data from at least 25% of the laboratories were excluded as
outliers in 9 of the 19 matrices tested. Is this due to instrumentation, sample matrices,
or the way the titration endpoint is determined? Are there additional instructions,
system checks, and/or maintenance procedures that should be added to the
method to improve precision?
Supporting Information
•
General Comments
•
Performance Characteristics and compared to approved SMPR:
Analytical Range:
SMPR range 5-500 mg/100g; MLT sample range ~ 20-700 mg/100g.
LOQ: