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FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
(DRM)
2
Method demonstrates excellent repeatability and reproducibility. With all MLT data
included, repeatability ranged from 2.26-7.03% RSD and reproducibility data ranged
from 3.04-9.48% RSD.
Did Method Author Consider ERP’s Method Specific Recommendations (See web link to specific method
comments):
Any Revision to Method Scope/Applicability of Method:
Biocytin was added to the method to extend method applicability to “total” biotin
although none was detected in any of the MLT matrices.
General comments (i.e. safety) about the method:
•
Feedback from Users of the Methods since being awarded First Action
Official Methods
Status
One lab suggested changing the pH of the buffer to 4.0 to obtain a clear filtrate.
Method needs a detailed description of the “back Flush” technique. Syringe filters need
to be tested for possible interferences before they are used.
Additional Pros/Strengths:
Method relatively simple and easy to perform. Method has excellent repeatability and
reproducibility.
Additional Cons/Weaknesses
Method needs more detailed description of “back Flush” technique.
Supporting Information
•
General Comments
•
Performance Characteristics and compared to approved SMPR:
Analytical Range:
SRM range 0.1-150 mcg/100g. MLT sample range ~ 4-260
mcg/100g.
LOQ:
Accuracy/Recovery:
Precision (RSD
r
):
SMPR: < 6% RSD, MLT range – 2.26-7.03% with no outliers excluded.