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FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
1
Expert Review Panel for Infant Formula and Adult Nutrition
Evaluation of Method:
BVit-02 #2
Title:
Simultaneous Determination of Total Vitamin B6, B2, B3 and B1 in Infant Formula Products by LC-MS/MS
Using Enzymatic Digestion
Author:
Abbott
Summary of Method:
First Action method for B1, B2, B6 and discussion of submission relates to possible bias for B3.
Method Scope/Applicability:
Infant Formula and Adult/Pediatric Formulas
General comments about the method:
Method Clarity:
Method Safety Concerns:
Pros/Strengths:
Cons/Weaknesses
Supporting Data
Data provided illustrates that there is no bias between Abbott method and that from Mead Johnson. At
previous meeting it was found that initial there was a high bias for Abbott method that this may be caused
by B3 coming from the enzyme.
No report attached which does not address the concern that B3 is not present in enzyme
The data just shows that this method gives same result as MJ method.
However, since this was only a hypothesis, the fact that there is no bias suggests that no problem for B3
exists.
Performance Characteristics:
Analytical Range:
LOQ:
Accuracy/Recovery:
BVit-02 Review Forms