OMB Meeting Book_9-11-14

AOAC INTERNATIONAL Stakeholder Panel for Infant Formula and Adult Nutritionals (SPIFAN)

USER COMMENTS 

COMMENT PARAMETERS 

AOAC OMA 

2011.20 

Method Name/Manuscript Title 

5’ Mononucleotides in Infant Formula and Adult Nutritionals by liquid  chromatography 

Manuscript Reference  In your experience using the method, does the  method perform according to the method’s  applicability as written?  In your experience with the method, is there  any safety concerns identified while using or  regarding use of the method?  Do you have any information that supports  regarding the reproducibility of the method as  written:  If so, please specify and submit  information?  Please attach any documentation to support  your feedback, if available.    Based on your experience with the method,  are there any recommended changes to the  AOAC First Action Method as written? 

This method did not meet the ranges listed for SRM 1849a.  CMP and  GMP were both high out of spec. 

Also, results near the LOQ showed poor chromatography. 

No safety concerns were noted. 

Reproducibility meets the SMPR however it is on the high side at low  levels. 

See 2011.20 chromatogram 

This method has the following limitations:  Heavy and time consuming sample preparation ‐ Numerous  interferences leading to difficulties with integration.  Although the SMPR does not list a minimum time for results, this  method’s time of analysis significant when performing the required  SPE step.  When dealing with unknown samples analysts would not  know if the sample requires ultra‐centrifugation until loaded onto the  SPE cartridge.  At that time the sample would need to be repeated.  In addition to these disadvantages, the method was not applicable as  it is to some products such as due to Interferences in the LC‐DAD  chromatograms.  The SMPR states “It would also be desirable to measure the  corresponding nucleosides”  This candidate method cannot be  applied to nucleosides.  However, further investigation might allow  2011.21 to adapt the method and include them in the future.  At this time I would not recommend changes to this method.  I would  recommend that 2011.21 be re‐reviewed  and subjected to MLT for  comparison to this methods data.   

At this time I do not see this method having dispute method criteria.