Low Lactose ERP - Review Book

3. Are the definitions specified in the SMPR used and applied appropriately in the method? If no, please indicate how the terms are used.

The definitions were followed but they were not appropriately summarized. The summary (Section M) states that

The quantification of lactose by ion chromatography with Inline Dialysis and amperometric detection described in this document is reliable, robust and reproducible. The data presented in this report verifies and validates that this method fits the purpose intended and shows that this method meets the parameters required according to the AOAC SMPR® 2018.09. With our request for additional time and a resubmission we will be able to hand-in the full scope of method validation to fulfill all requirements properly. There is no Reproducibility data, Table 13 states Repeatability Precision though it may be interpreted as Intermediate Reproducibility (different columns and on various days). The SMPR number is 2018.009. There is an explicit statement from the author that the data is insufficient which is correct.

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). III. Review of Supporting Information 1. Are the definitions specified in the SMPR used and applied appropriately in the supporting documentation (manuscripts, method studies, etc...)? If not, please explain the differences and if the method is impacted by the difference. 2. Is there information demonstrating that the method meets the SMPR Method Performance Requirements using the Reference Materials stated in the SMPR? If not, then specify what is missing and how this impacts demonstration of performance of the method.

The precautions are very limited (which is/should be good practice in any laboratory). It would be good to address those chemicals / processes / equipment / operation that need special attention.

The method and studies and integrated into one document. The definitions were not accurately applied to the literature. Examples are Precision Tables, SMPR number, SRM number etc.

The reference material information is not complete. The NIST SRM 2383a is not used. The method performance is NOT demonstrated on full matrix range.