OMB Meeting Book_9-11-14 - page 77

COMMENT PARAMETERS 
USER COMMENTS 
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? 
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. 
In your experience with the method, is there 
any safety concerns identified while using or 
regarding use of the method? 
No safety concerns were noted. 
Do you have any information that supports 
regarding the reproducibility of the method as 
written:  If so, please specify and submit 
information? 
Reproducibility meets the SMPR however it is on the high side at low 
levels. 
Please attach any documentation to support 
your feedback, if available.   
See 2011.20 chromatogram 
Based on your experience with the method, 
are there any recommended changes to the 
AOAC First Action Method as written? 
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. 
AOAC INTERNATIONAL
Stakeholder Panel for Infant Formula and Adult Nutritionals (SPIFAN)
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