SPSFAM EXPERT REVIEW PANEL

AOAC SPDS ERP REVIEW: MAIN FORM

Submission Date

2017-09-15 15:29:12

Name

Kasi Somayajula

E-mail

ksomayajula@coca-cola.com

Organization

The Coca-Cola Company

Title of Method

Determination of Bisphenol A (BPA) in commercially packaged ready to consume carbonated and non-carbonated water and non-alcoholic beverages: A single Laboratory Validation (SLV) Method

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

BPA-04

Applicable SMPR

2017.XXX V7

Summary:

Quantitation of BPA in ready to drink consumer beverages using LC/MS/MS method. The authors tested and validated the method for all the ten matrices that the SMPR suggested. Overall, the sample preparation is simple, good validation in all the matrices tested and satisfies the requirements of the SMPR.

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).

Yes.

The analytical technique does meet the SMPR. One small difference is that SMPR requires that the concentration of the blank is to be < 10% of the expected LOQ. The authors hinted that the blank concentration can be < 50% of the reporting limit as a system suitability parameter.

Mostly the definitions from SMPR are used. One deviation was for LOQ where S/N > 10 was used by authors which may be normally acceptable when matrix blank is 'clean'. SMPR required use of blank + 10 * standard deviation for LOQ.

One concern is the use of ammonium fluoride as a mobile phase additive. This does have analytical advantages in improving sensitivity. But has some concerns raised in literature. As an example, "... potentially an aggressive mobile phase additive that could have detrimental effects on column lifetime", Joseph Pesek et al, J. Chromatography A,

1401, 2015, 69. This can also sublime and form HF (https://en.wikipedia.org/wiki/Ammonium_fluoride).