Low Lactose ERP - Review Book

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 authors have included a statement advising users to refer to MSDS sheets of chemicals prior to use. Chemicals with risks are not uncommon in a laboratory (sodium hydroxide, ethanol, methanol)

No authors have assessed “Reproducibility” on check standards in a single lab on different days. This is not an estimate of reproducibility, which needs to be assessed by analysing samples (not check standards) in different laboratories.

Reference sample:

- SRM 1869a has been analysed and recovery is acceptable (although the recovery figure reported in Table 10 doesn't look correct). Unfortunately RSD(r) has not been assessed

- MUVA-ML-2310 has been analysed and recovery is acceptable (Table 10) and RSD(r) is also acceptable (Table 12)

- MUVA-CA-0904 has been analysed but insuifficient data points were recorded.

Overall the available data only supports the method applicability to the analytical range >100 - 2000 mg/100g. Not to the actual low lactose ranges.