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AOAC Stakeholder Panel on Dietary Supplements  Report on the 3 rd  SPDS Expert Review Panel Session 

Aloin A and Aloin B Method Reviews and Decisions Aloin ERP Members Present:   Brian Schaneberg, Starbucks (Chair);  Joseph Betz, NIH;  Quanyin Gao, Herbalife;  Holly Johnson,  Alkemist; Phillip Koerner, Phenomonex; Jasen Lavoie, Pharmachem; Charles Metcalfe, Custom Analytics; Tom Phillips, MD Dept of  Ag; Aniko Solyom, GAAS Analytical; Jianming Tao, Spectrix Analytical Services Aloin ERP Members Absent:   Nour Eddine Es‐Safi, Mohammed V University Rabat; Klaus Reif, PhytoLab; Darryl Sullivan, Covance;  Marina Torres, LATU  Observers:    Adam Kuszak, NIH; MIDI Guys; Milda Embuscado, McCormick; Tetsuhisa Goto, Shinshu University; Gary Jackoway, MIDI,  Craig Kunitsky, MIDI, Kurt Young, GNC/Nutra Manufacturing,  Joseph Zhou, Sunshineville;  AOAC Staff:   Scott Coates, Christopher Dent, Dawn Frazier, Deborah McKenzie AOAC  Method #  Manuscript Title,  Submitter and Reviewer  ERP Decisions Consensus Decision  Date  ALN‐01  08/02/2016

The ERP voted not to move this method to First Action Official  Methods  Status at this time.  The ERP voted that the following  must be completed prior to another First Action  consideration:   Is there data on additional matrices?   Raw data used for system suitability?   Raw data for peak purity data (diode array)    Is there data demonstrating limit of quantitation using the  target analyte?     What was done to HPLC system, was anything done to  optimize the system against the column sizes? The ERP voted to move this method to First Action Official  Methods  Status.  The ERP voted that the following must be  completed prior to Final Action consideration:   Demonstrate 5ppb LOQ   Correct typo in tables for accuracy and recovery   Provide data for other matrices i.e. repeatability   Recognition of column temperature control    Data clarifying why the lambda max was not used

MOTION , Betz/Gao, not to move  ALN‐01 to First Action.  10 in favor, 0 opposed, 0  abstentions. The motion passed.  MOTION, Betz/Solyom to accept  the First Action recommendations  as presented.  10 in favor, 0 opposed, 0  abstentions. The motion passed.  MOTION , Solyom/Betz, to move  ALN‐02 to First Action.   9 in favor, 0 opposed, 1 abstention  (Gao).   The motion passed.   

Determination of Aloin A  and Aloin B in Aloe Vera  Raw Materials and  Finished Products by HPLC:   Single Lab Validation.   By  Paula Brown, Ronan Yu,  Chiow Hui Kuan, Jamie  Finley, Elizabeth Mudge,  Steven Dentali  Determination of Aloin A,  Aloin B, and Aloe‐emodin  in Raw Materials and  Finished Products by HPLC.   By Herbalife.   

ALN‐02 

08/02/2016

03/12/2018

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