Microsoft Word - Candidates for 2017 ERP of the Year

Method # Manuscript Title, Submitter and Reviewers

ERP Decisions / Consensus

MOTION not to move candidate method BPA-02 to First Action Official Methods of Analysis Status (Ackerman/Yadlapalli) 7 in favor, 0 opposed, 1 abstentions. The motion passed. Reasoning/Summary : The method authors have provided written documentation explaining how they have addressed the original concerns expressed by the ERP on September 26, 2017 1 . However, the ERP asserted that several points required further attention prior to being voted to First Action Official Methods of Analysis ® status. These requirements and recommendations were agreed as follows: Requirements for First Action: • Authors must conduct a LOD/LOQ study using a lower concentration blank beverage sample. The LOD/LOQ must be calculated as indicated in the SMPR using the blank mean plus the standard deviation. They do not need to repeat the recovery study using this sample. • System suitability requirements must be included in the method as written to provide specific instructions to the user. For example, provide acceptance requirements for criteria listed in the SMPR. • Additional detail needed about lower level calibrant that was used in the study but preparation not described in the method. • Add information about necessary PPE in the safety section. • In Figure 4, axis labels must be added. • Parameters for immuno-affinity column should be added, including capacity and as much detail as possible. While this may be the only size/capacity offered by the manufacturer at this time, it should be clearly stated in such a way that future method users can identify the correct cartridges. Recommendations for First Action: • A concern was raised that no spiking study was conducted at the LOQ level. The ERP acknowledges that this is not a requirement of the SMPR, and when the LOD/LOQ study is repeated with a spiked lower level sample, the recovery can be inferred from that data. • In Figure 4, all three curves, including regression lines and standard deviations for coefficients “a” and “b”, should be added. • Concerns were expressed about the separation of BPA peak from the non-retained peak. Authors may want to consider modifying the chromatography to increase retention of BPA. • Concerns were expressed about the specificity of the method for BPA compared to related compounds. Authors may want to consider a quick study with some pure materials for related compounds to demonstrate selectivity either via the cleanup cartridge or the separation scheme.

Title: Determination of Free Bisphenol A (BPA) in Commercially Packaged Ready to Consume Carbonated/Non-Carbonated Water and Non-Alcoholic Beverages by Immunoaffinity Purification and UPLC/Fluorescence Detector Author(s): J. Liu, Z. Wu, H. Zhang, C. Xi, X. Wang, L. Chen, D. Toth

Submitted by: Danrey Toth

Primary Reviewer:

Mehmet Gumustas, Hitit University, Turkey

Secondary Reviewer:

Jing Tan, Abbott Nutrition

BPA-02 (Resubmission)

1 List of Revisions to BPA-002