March 17, 2015-SP

3/17/2015

FDA PUBLICATION (2007)

• LC-MS based “primary” quantitiave method • Simple to use with existing laboratory instrumentation Q i i d ifi • uant tat ve an spec c • Primary method supported by a secondary confirmatory method • Secondary method is “derivatization” based analysis (2-NPH) • Secondary method is “qualitative” • Not shown to work with milk based nutritional products

Proprietaryand confidential — do not distribute © 2015 Abbott Laboratories

7

March17,2015

MFA‐AOAC,2015 

MILK PRODUCTS METHOD DEVELOPMENT GOALS

• LC-MS based “primary” quantitiave method • Quantitative and specific (2 MRM transitions) Si lifi d l i h ( 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 • Multi day method performance data (2 labs, 2 LC-MS platforms) • Target concentation of 30 ppb in powders i i i )

Proprietaryand confidential — do not distribute © 2015 Abbott Laboratories

8

March17,2015

MFA‐AOAC,2015 

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