AOAC_SPDS_ERP_-_Set_3

2. Does the method contain system suitability tests or controls as specified by the SMPR? If not, please indicate if there is a need for such tests or controls and which ones. 3. Is there information demonstrating that the method system suitability tests and controls as specified in the SMPR worked appropriately and as expected? If no, please specify. 4. Based on the supporting information, is the method written clearly and concisely? If no, please specify the needed revisions. 5. Based on the supporting information, what are the pros/strengths of the method? 6. Based on the supporting information, what are the cons/weaknesses of the method?

Yes, it contains suitability tests applicable to the SMPR.

Yes.

Yes, the method is written in clearly and concisely, and thoroughly elucidates the necessary steps and materials needed.

The pros of this method are that it utilizes a rugged, precise method that has been a methodology of choice for amino acid analysis. The post-column derivatization step eliminates the problems associated with pre-column derivatization.

The cons/weaknesses are those that are encountered with the general methodology/instrumentation used; long run times, staining from ninhydrin reagent, use of instrumentation/columns/buffers that are only useful for a narrow purpose.

7. Any general comments about the method?

In general this method would be ideal for labs that are already doing free amino acid testing using post-column derivatization HPLC.

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.

Yes, after limitations are discussed and evaluated.