Amino-01 (July 2018)

Amino-01 (JULY 2018) 180124 AA SPIFAN SLV Appendix J

FOR ERP USE ONLY DO NOT DISTRIBUTE

Single Laboratory Validation Report for Total Amino Acids by UHPLC-UV in Infant Formulas and Adult Nutritionals – APPENDIX J

ERP request: investigate optimizing chromatography (peak resolution criteria) cysteine methionine This has not been a request for other SPIFAN methods. If specific criteria (USP or other) is required, laboratories would not have the ability to reference their own quality system criteria. Below is a typical expectation of CYS-MET resolution. This is zoomed closer than provided in the original SLV report. Note the USP resolution of 1.6. Method authors do not recommend adding this criteria to the method.

NIST 1849a

0.065

0.060

0.055

Val - 18.434

0.050

0.045

0.040

NVa - 18.738

0.035

AU

Tyr - 17.790

0.030

Met - 18.175

0.025

0.020

0.015

0.010

xCys - 18.068

0.005

0.000

Minutes 17.55 17.60 17.65 17.70 17.75 17.80 17.85 17.90 17.95 18.00 18.05 18.10 18.15 18.20 18.25 18.30 18.35 18.40 18.45 18.50 18.55 18.60 18.65 18.70 18.75 18.80 18.85 18.90

Jaudzems, Guthrie, Lahrichi, and Fuerer – January 2018

page 4/6