Low Lactose ERP - Review Book

6. Based on the supporting information, what are the cons/weaknesses of the method?

Method uses equipment that can be fussy at time, but the method's quality checks will monitor its performance.

7. Any general comments about the method?

Points that need addressing: 1) The method abstract states sugars are extracted from both solutions using an aqueous-ethanol solution; however the method protocol only states water is used. The ethanol must be confirmed since ethanol is needed to denature enzymes present in the sample, a criteria listed in the SMPR. 2) Adjust the SLV report to properly report RSDr and RSDR as stated in the above section. 3) The validation raw data was not easy to decipher given the verbiage. This should be clarified especially for the LOD determination. 4) One step is adding lactose to one of the 2 subsamples. If this is to assess enzyme performance, it should be stated in the method along with acceptance criteria.

V. Final Recommendation Do you recommend this method be adopted as a First Action and published in the Official Methods of Analysis of AOAC INTERNATIONAL? Please specify rationale.

I recommend the method for adoption as First Action if the general comments described above are satisfactorily met.