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3/17/2015
4
FDA PUBLICATION (2007)
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LC-MS based “primary” quantitiave method
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Simple to use with existing laboratory instrumentation
Q i i d
ifi
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uant tat ve an spec c
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Primary method supported by a secondary confirmatory method
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Secondary method is “derivatization” based analysis (2-NPH)
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Secondary method is “qualitative”
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Not shown to work with milk based nutritional products
Proprietaryand confidential — do not distribute
© 2015 Abbott Laboratories
March17,2015
MFA‐AOAC,2015
7
MILK PRODUCTS METHOD DEVELOPMENT GOALS
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LC-MS based “primary” quantitiave method
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Quantitative and specific (2 MRM transitions)
Si lifi d
l
i h (
i
i i i )
•
mp e samp e preparat on sc eme prote n prec p tat on
•
Primary method supported by a secondary confirmatory method
•
Secondary method is “derivatization” based analysis (2-NPH)
•
Secondary method is “quantitative” (1 MRM transition)
•
Show applicability with milk based nutritional products
Proprietaryand confidential — do not distribute
© 2015 Abbott Laboratories
•
Multi day method performance data (2 labs, 2 LC-MS platforms)
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Target concentation of 30 ppb in powders
March17,2015
MFA‐AOAC,2015
8