SPSFAM EXPERT REVIEW PANEL

AOAC SPSFAM ERP REVIEW: MAIN FORM

Submission Date

2017-09-15 11:19:49

Name

Luke Ackerman

E-mail

Luke.Ackerman@fda.hhs.gov

Organization

FDA

Title of Method

BPA in Water

AOAC Candidate Method Number (e.g. ALN-01)

BPA-01

Applicable SMPR

BPA

I. Summary of the Method

Online SPE - HPLC-ECD to quantify BPA in water. 1mL injection. 5x1mmx5um C18 SPE with 10% ACN wash (50mM Acetate ph 4.8), isocratic elution with 40% ACN (50mM Acetate ph 4.8) on 150x2.1mmx3um c18 column. ECD detection on 2mm glassy carbon electrode at t~5.2 min. External calibration? Method apparently applies to online SPE/LC ready water samples. It is missing any application to beverages other than water and any beverage with particles, emulsions, high TOC/SSC.

II. Review of the Method Only 1. Does the applicability of the method support the applicability of the SMPR? If not, please explain what is missing. 2. Does the analytical technique(s) used in the method meet the SMPR? If not, please specify how it differs from what is stated in the SMPR. 3. Are the definitions specified in the SMPR used and applied appropriately in the method? If no, please indicate how the terms are used. 4. Does the method, as written, contain all appropriate precautions and warnings related to the method's reagents, components, instrumentation, or method steps that may be hazardous? If no, please suggest wording or option(s).

The general technique might be able to meet the SMPR but the submitted method does not provide any data or examples of its ability to meet the accuracy and precision requirements, either across the quantitative range, or in beverage samples. It is highly unclear in its sensitivity determination. It did not address blanks, performance across beverage matrices, and it did not follow SMPR procedures for sensitivity/quantitative limit determination. No. LOD as defined in SMPR is not used and the method does not specify how the reported LOD was determined. LOQ is never mentioned. Accuracy is never assessed or discussed.

No. No mention is made regarding safe handling of organic solvents, neat chemicals, PPE such as eye goggles, gloves, lab coats, closed toe shoes, or hazards of instrumentation (shock or mechanical). Realistically this method probably has minimal hazards relative to some other methods, but standard warnings (especially about preparation of mobile phases and standards) should be included.