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ERP Final Action Recommendation Report for AOAC Official Method 2012.16,
Pantothenic
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Acid (Vitamin B5) in Infant Formula and Adult/Pediatric Nutritional Formula – Ultra-
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Performance Liquid Chromatography – Tandem Mass Spectrometry Method (First Action
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2012)
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EXECUTIVE SUMMARY:
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AOAC Official Method 2012.16,
Pantothenic Acid (Vitamin B5) in Infant Formula and Adult/Pediatric
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Nutritional Formula
(AOAC 2012.16) was originally a method submitted by Nestle Research Center in
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Switzerland in response to a Call for Methods that purported to meet the standard method performance
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requirements (SMPR) for pantothenic acid (AOAC 2012.009) established by the AOAC Stakeholder Panel
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on Infant Formula and Adult Nutritionals (AOAC SPIFAN) in 2012. The method was reviewed by the
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AOAC Expert Review Panel for SPIFAN Nutrient Methods (ERP) and was judged to have sufficiently met
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the AOAC 2012.009. The ERP adopted the method, making it an AOAC First Action
Official Methods of
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Analysis
.
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The ERP tracked this method for two years. During this time, the method was published in the
Official
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Methods of Analysis of AOAC INTERNATIONAL
(OMA) and in the
Journal of AOAC INTERNATIONAL
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(Journal). Additionally, a manuscript with a method comparison of AOAC 2012.16 to the traditional
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microbiological reference assay, AOAC 992.07, a microbiological assay was published in the Journal. This
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comparison was reviewed by the ERP and they determined that any suggestions and modifications could
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be addressed as the method moved forward for reproducibility assessment in a multi-laboratory study.
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In March 2015, the ERP reviewed the method and all data supporting the method’s reproducibility. In
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preparation for the discussion, AOAC has listed the method in the Referee Section of the AOAC
Inside
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Laboratory Management
publication as the method selected for multi-laboratory testing and
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subsequently as the method likely to be considered for Final Action recommendation by the ERP.
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Additionally, AOAC sent out two email blasts to its member and network database (>5,000 contacts) to
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solicit feedback on the method from users of the method. No feedback was received as a result of these
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efforts. Additionally, ERP members were asked to review the method using a form that is based on the
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OMB’s guidance to ERPs for First to Final Action (OMA Appendix G). The ERP did discuss some feedback
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from meeting attendees. The one comment that the ERP thought should be clarified in the method is
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adding a comment regarding ensuring the the drying and ensuring the moisture content of the Calcium
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pantothenate standard before use. It was agreed that clarifications would be provided in the method
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