Low Lactose ERP - Review Book

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

The technique restricts the method to Metrohm Ion Chromatograph due to Patented Inline Dialysis as automatic, nested Inline Sample Preparation. This makes this method to be proprietary category unless an alternative valid cleanup is demonstrated for along with the automated process. The validation to include more matrices as given in the scope of the SMPR document. The validation protocol should be designed to address the performance criteria set in the SMPR. AOAC validation guidelines should be followed for performing validation and statistical evaluation of data and conclusion. The section numbering should follow standard guidelines like Journal of AOACI. Health and Safety precautions to be included wherever necessary. The method seems promising, however based on the current data it is difficult to adjudicate whether it meets the SMPR. The proprietary in line dialysis automation may be a time saver but alternative valid cleanup should be demonstrated so that the method is not restricted to any make / model.

7. Any general comments about the method?

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.

Based on the current data I make a motion to delay the decision for potential first action status of this method pending the remarks and suggestions made.