Microsoft Word - Candidates for 2017 ERP of the Year
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STAKEHOLDER PANEL ON STRATEGIC FOOD ANALYTICAL METHODS EXPERT REVIEW PANEL ON SPDS SET 1 INGREDIENTS (Anthocyanins, Chondroitin, and PDE5 Inhibitors) Conclusion: The Expert Review Panel reviewed four (4) Chondroitin methods, three (3) Anthocyanins methods, and five (5) PDE5 Inhibitors Methods, which were submitted in response to the Call for Methods. One Chondroitin Method (CHON-004) and one PDE5 Inhibitor Method (PDE5-005) were adopted as First Action Official Methods SM . Methods Reviewed: Each Anthocyanins, Chondroitin, and PDE5 Inhibitors method collected by AOAC for consideration by this ERP was assigned a primary and secondary reviewer. The decisions of the August 3-4, 2015 ERP are shown below.
I.
Chondroitin – August 3, 2015
Chondroitin ERP Members Present: Brian Schaneberg, Starbucks (Chair); Jana Hildreth, Synutra Pure; Martha Jennens, Covance; Phillip Koerner, Phenomenex; Tom Phillips, State of MD; Curtis Phinney, Consultant; Kelly Reins, Consultant; John Spzylka, Merieux NutriSciences; Aniko Solyom, GAAS Corporation; Darryl Sullivan, Covance.
Chondroitin ERP Members Absent: Liton Roy, Sancillo and Company; Nour Edine ES-SAFI, Mohammad V University Rabat
AOAC Method #
Manuscript Title and Submitter
ERP Decisions
Consensus
Reviewers
CHON-001
Title: “Selected Adulterants in Dietary Ingredients and Dietary Supplements Containing Chondroitin Sulfate”
Motion 1: MOTION to not move CHON-001 to First Action Official Methods SM status. Motion 2: MOTION that the method author should submit probability of detection (POD) data at the minimum detection level for the compounds listed in Annex I of AOAC SMPR 2014.008. Motion 1: MOTION to not move CHON-002 to First Action
Motion 1: Hildreth/Phinney, 9/0/1 (Abstain: Covance) Motion 2: Hildreth/Jennens, 9/0/1 (Abstain: Covance) Motion 1: Reins/Hildreth,
Primary: Jana Hildreth
Secondary: Curtis Phinney
Submitted by: Gabriel Giancaspro, USP
CHON-002
Title: Isotachophoretic Determination
Primary: Kelly Reins
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Official Methods SM status.
9/0/1 (Abstain: Covance)
of GA and CS in Dietary Supplements
Secondary: Curtis Phinney
Submitted by: Frantisek Kvasnicka, University of Chemistry and Technology, Prague
CHON-003
Title: Chondroitin by IR and Dimethylmethylene Blue (DMMB) Spectrophotometry
Motion 1: MOTION to not move CHON-003 to First Action Official Methods SM status. Motion 2: MOTION to ask the method author whether they can provide additional data regarding the interfering compounds that are listed on the SMPR008 and if they have additional data for system suitability / all validation data. MOTION 1: MOTION to move CHON-004 to First Action Official Methods SM status. Motion 2: MOTION to be considered for Final Action Official Methods SM status, the author(s) should: • Optimize and control the moisture in the chondroitin sulfate including appropriate vessels and glassware.
Motion 1: Solyom/Spzylka 9/0/1 (Abstain: Covance)
Primary: Aniko Solyom Secondary: Nour Eddine Es-Safi
Submitted by: Xun Yan, Amway
Motion 2: Solyom/Hildreth 9/0/1 (Abstain: Covance) Motion 1: Sullivan/Koerner, 8/0/2 (Abstain: Covance, Hildreth) Motion 2: Sullivan/Reins 8/0/2 (Abstain: Covance, Hildreth)
CHON-004
Title: Determination of Chondroitin Sulfate Content in Raw Materials and Dietary Supplements by High- Performance Liquid Chromatography with Ultraviolet Detection After Enzymatic Hydrolysis
Primary: Darryl Sullivan
Secondary: Phillip Koerner
Submitted by: David Ji, Analytical Laboratories in Anaheim, Inc.
• • • •
Investigate alternative LC columns.
Optimize the LC conditions.
Look at lessons learned from USP.
Include a potency evaluation of the enzyme use. Investigate use of the USP standard that is currently available. Certified reference material recommended.
•
•
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II.
Anthocyanins - August 3, 2015
Anthocyanins ERP Members Present: Brian Schaneberg, Starbucks (Chair); Phil Koerner, Phenomenex; Jungmin Lee, USDA; Melissa Phillips, NIST; Martha Jennens, Covance; Tom Phillips, State of MD; Aniko Solyom, GAAS Analytics; John Spzylka, Mérieux NutriSciences; Darryl Sullivan, Covance
Anthocyanins ERP Members Absent: Nour Eddine ES-SAFI, Mohammed V University; Liton Roy, Sancilio and Company; Jerry Zweigenbaum, Agilent
AOAC Method #
Manuscript Title and Submitter
ERP Decisions
Consensus
Reviewers
ANTH-001
Title: Determination of Anthocyanins in Brazilian and Floridian Açaí (Euterpe oleraceae Mart) Using LC-MS/MS
Motion 1: MOTION to not move ANTH-001 to First Action Official Methods SM status with no further action.
Motion 1: Lee/Phillips, 7/0/1 (Abstain: Covance)
Primary: Jungmin Lee Secondary:
Submitter: Kevin Tran, FDA
Melissa Phillips
ANTH-002
Title: Total Monomeric Anthocyanins By HPLC
Motion 1: MOTION to not move ANTH-002 to First Action Official Methods SM status with no further action.
Motion 1: Jennens/Solyom, 7/0/1 (Abstain: Covance)
Primary: Aniko Solyom Secondary: Martha Phillips Primary: John Spzylka Secondary: Not Submitted
Submitter: Melanie Bush, Artemis International
ANTH-003
Title: Anthocyanin Profiles by HPLC with DAD and MS Detections
Motion 1: MOTION to not move ANTH-003 to First Action Official Methods SM status with no further action.
Motion 1: Spzylka/Solyom, 7/0/1 (Abstain: Covance)
Submitter: Bob Durst, Oregon State Unviersity
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III.
PDE5 Inhibitors– August 4, 2015
PDE5 Inhibitors ERP Members Present: Brian Schaneberg, Starbucks (Chair); Phil Koerner, Phenomenex; Katerina Mastovska, Covance; Tom Phillips, State of MD; Fenhong Song, FDA; John Spzylka, Mérieux NutriSciences; Darryl Sullivan, Covance.
PDE5 Inhibitors ERP Members Absent: Teresa Cain, FDA; Liton Roy, Sancilio; Jerry Zweigenbaum, Agilent.
AOAC Method #
Manuscript Title
ERP Decisions
Consensus
Reviewers
PDE5-001
Title: Screening Method for Phosphodiesterase Type 5 (PDER5) Inhibitors in Dietary Ingredients and Supplements using High Resolution Mass Spectrometry
Motion 1: MOTION to not move PDE5-001 to First Action Official Methods SM status. Motion 2: ERP finds this method intriguing and would like to see a further submission of data demonstrating applicability towards the SMPR 2014.012. Motion 1: MOTION to not move PDE5-002 to First Action Official Methods SM status. Motion 2: MOTION that the ERP finds this method valuable for screening and would like to see a further submission of data demonstrating applicability towards the SMPR 2014.012. Motion 1: MOTION to not move PDE5-003 to First Action Official Methods SM status. Motion 2: MOTION that this method should: 1. Supply single lab validation data related to LOD. 2. Supply LIB data if available, and any other
Motion 1: Phillips/Sullivan, 6/0/1 (Abstain: Covance) Motion 2: Phillips/Sullivan, 6/0/1 (Abstain: Covance)
Primary: Tom Phillips Secondary: Not Submitted
Submitter: Brian Musselman, IonSense
PDE5-002
Title: Screening Method for Phosphodiesterase Type 5 (PDE5) Inhibitors in Dietary Ingredients and Supplements
Motion 1: Mastovska/Koerner, 6/0/1 (Abstain: Covance) Motion 2: Mastovska/Spzylka, 6/0/1 (Abstain: Covance)
Primary: Katerina Mastovska Secondary: Not submitted
Submitter: Tien Do, Camag
PDE5-003
Title: Adaption of the LC-MS Screen for PDE5 Inhibitors to UHPLC-MS
Motion 1: Koerner/Phillips, 5/0/2 (Abstain: Covance, Song)
Primary: Phillip Koerner
Submitter: Elisa Nickum, FDA
Secondary: John Spzylka
Motion 2: Koerner/Spzylka, 6/0/1 (Abstain:
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data that exists in support of this method's applicability to the SMPR 2014.012 or 2014.010.
Covance, Song)
PDE5-004
Title: Testing for Phosphodiesterase Type 5 (PDE5) Inhibitors in Dietary Supplements
Motion 1: MOTION to not move PDE5-004 to First Action Official Methods SM status. Motion 2: MOTION that ERP finds this method valuable for screening and would like to see a further submission of data demonstrating applicability towards the SMPR 2014.012. Motion 1: MOTION to move PDE5-005 to First Action Official Methods SM status. Motion 2 : MOTION to be considered for Final Action Official Methods SM status, the method author(s) should: 1. Provide reproducibility data 2. Break out AOAC SMPR 2014.011: -Matrix match spike recovery -Recovery options 3. Beak out AOAC SMPR 2014.012 and AOAC SMPR 2014.010.
Motion 1: Phillips/Sullivan, 7/0/1 (Abstain: Covance) Motion 2: Phillips/Spzylka, 7/0/1 (Abstain: Covance) Motion 1: Phillips/Koerner, 5/0/2 (Mastovska , Sullivan) Motion 2: Phillips/Spzylka, 5/0/2 (Mastovska , Sullivan)
Primary: Jerry Zweigenbaum
Submitter: Said Goueli, Promega
Secondary: Teresa Cain
Note: This method was supplemented with a presentation from the method author. Title: SLV Study of a Method for Screening Submitter: Katerina Mastovska, Covance
PDE5-005
Primary: Teresa Cain Secondary: Tom Phillips
-Feedback from other users and a mechanism to receive that feedback.
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STAKEHOLDER PANEL ON DIETARY SUPPLEMENTS EXPERT REVIEW PANEL ON SPDS SET 2 INGREDIENTS (Ashwagandha, Folin C and Kratom)
OFFICIAL CHAIR’S EXPERT REVIEW PANEL REPORT
ACKNOWLEDGMENT
The undersigned Chair hereby confirms that the following document has been reviewed and constitutes the final revised version of the Official Chair’s Report for the SPDS Set 2 Ingredients (Ashwagandha, Folin C and Kratom) Expert Review Panel held on December 9-10, 2015.
____________________________________________________________
DARRYL SULLIVAN, SPDS SET 2 INGREDIENT EXPERT REVIEW PANEL CHAIRMAN
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STAKEHOLDER PANEL ON DIETARY SUPPLEMENTS EXPERT REVIEW PANEL ON SPDS SET 2 INGREDIENTS
METHODS FOR CONSIDERATION:
Conclusion: The Expert Review Panel reviewed one (1) Ashwagandha method, three (3) Folin-C methods, and five (5) Kratom Methods, which were submitted in response to the Call for Methods. Methods Reviewed: Each Ashwagandha, Folin-C and Kratom method collected by AOAC for consideration by this ERP was assigned a primary and secondary reviewer. The decisions of the December 9-10, 2015 ERP are shown below.
I. Ashwagandha
Ashwagandha ERP Members Present: Darryl Sullivan, Covance (Chair); Anton Bzhelyansky, USP; Nour-Eddine Es-Safi, Mohammad V University of Rabat; Tom Phillips, State of MD; Casey Sayre, Roseman University of Health Sciences; Catherine Rimmer, NIST; Aniko Solyom, GAAS Analytical; Kurt Young, GNC/Nutra Manufacturing
Ashwagandha ERP Members Absent: Prashant Ingle, Herbalife; Yanjun Zhang, Herbalife
AOAC Method #
Manuscript Title
ERP Decisions
Consensus
Decision Date
Withanolide Glycosides and Aglycones of Ashwagandha ( W. somnifera )
MOTION, Young/Bzhelyansky, to move ASH-01 First Action. 8 in favor, 0 opposed, 0 abstain. The motion passed.
ASH-01
The ERP moved this method to First Action Official Methods Status.
December 10, 2015
The ERP recommended the method author complete the following actions to be completed prior to Final Action consideration:
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•
Investigate a better baseline separation for Peak 1 pH of phosphate buffer Column temperature Heat stability during the extraction Simplify the preparation of the extract products Limit number of reference standards to one withanolide and one withanoside with use of response factors Provide data on finished products When specifying columns put “or equivalent.” Clarify the discard volume in the filtration step Provide data on method LOQ
• • •
•
•
• •
•
•
ACTION ITEMS:
1. Staff: Send notification to method author, requesting MS Word copy of method/manuscript for publication. Send follow up documentation on requirements and ERP recommendations for Final Action Official Methods status consideration.
II. Folin C
Folin C ERP Members Present: Darryl Sullivan, Covance (Chair); Nour Eddine Es-Safi, Mohammad V University in Rabat; Martha Jennens, Covance; Dana Krueger, Krueger Food Laboratories; Tom Phillips, State of MD; Catherine Rimmer, NIST; Aniko Solyom, GAAS Analytical; John Spzylka, Mérieux Nutrisciences; Joseph Zhou, Sunshineville Health Products
Folin C ERP Members Absent: John Finley, LSU (Retired), Prashant Ingle, Herbalife; Jungmin Lee, USDA
AOAC Method #
Manuscript Title
ERP Decisions
Consensus
Decision Date
FOL-01
Folin-Ciocalteau Reagent for
No motion made.
December 10, 2015
The ERP agreed not to take action on this
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Polyphenolic Assay
method at this time. The ERP determined that the following actions must be completed before this method can reconsidered for First Action Official Methods status:
•
Clarify benefits of single vs. dual; ask which of the two is being submitted Clarification on purpose of the cleanup steps Clarify the major differences in the data between the two methods. Ask if there is data on sample matrices addressed in SMPR Need data on reference materials (available from Kate Rimmer, NIST)
•
•
•
•
• •
Use Gallic Acid for calibrant
Provide raw data
FOL-02
Method for the estimation of total phenolic content using the Folin-C assay
No motion made.
December 10, 2015
The ERP agreed not to take action on this method at this time. The ERP determined that the following actions must be completed before this method can reconsidered for First Action Official Methods status:
•
Need data on reference materials (available from Catherine Rimmer, NIST) Ask if there is data on sample matrices addressed in SMPR
•
• • •
Expand analytical range Data not completely clear More supporting data for
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recovery and LOQ
FOL-03
Modified Folin−Ciocalteu Antioxidant Capacity Assay for Measuring Lipophilic Antioxidants
No motion made.
December 10, 2015
The ERP agreed not to take action on this method at this time. The ERP determined that the following actions must be completed before this method can reconsidered for First Action Official Methods status:
• •
Need more data to meet SMPR Need data on reference materials (available from Catherine Rimmer, NIST) Ask if there is data on sample matrices addressed in SMPR Express as Gallic Acid equivalent Comparative data between traditional folin and modified folin between a range of matrices is required.
•
• •
Note: The Expert Review Panel for Folin-C has asked for additional clarification of the Standard Method Performance Requirements (SMPRs) , specifically the title, as this SMPR is not for total phenolics.
ACTION ITEMS:
1. Staff: Send notification to method authors respectively of the ERP decision and relevant ERP’s suggestions for each Folin C method to be considered for First Action Official Methods status. 2. Staff: Send notification to ERP member, Catherine Rimmer regarding the availability of reference materials for the Folin C methods. 3. Staff: Review and work on the ERP’s request for clarification of the SMPR
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III. Kratom ( Mitragyna speciosa)
Kratom ERP Members Present: Darryl Sullivan, Covance (Chair); Joseph Betz, NIH; Nour Eddine Es-Safi, Mohammed V University in Rabat; Charles Metcalfe, Custom Analytics; Tom Phillips, State of MD; John Spzylka, Mérieux Nutrisciences; Yan-Hong Wang, University of Mississippi
Kratom ERP Members Absent: Christine Casey, FDA; Catherine Rimmer, NIST
AOAC Method #
Manuscript Title
ERP Recommendations on Methods
Consensus
Decision Date
KRA-01
Quantitative and Qualitative Analysis of Mitragynine in Kratom ( Mitragyna speciosa) by GC-MS, LC-MS/MS and UPLC-PDA
December 9, 2015
•
Commercially available standards from Chromadex for 7 OH
• • •
Need to see recovery data
Include 7 OH data
Range of quantification must cover whole range from SMPR Precision and accuracy data is needed across entire range of quantification Interest from ERP is in the tandem MS method LOD and LOQ information for 7- OH required. Repeatability must be improved More accuracy and recovery data
•
•
KRA-02
Quantification of Mitragynine in Kratom Raw Materials and Finished Products by
December 9, 2015
•
• • • •
High-Performance Liquid Chromatography: Singly Laboratory Validation
Peak purity PDA
MOTION to accept the requested actions as written for KRA-01, KRA-02, KRA-03, KRA-04. Motion by Szpylka, second by Metcalfe. 7 in favor, 0 opposed, 0 abstain. MOTION PASSED.
Examine additional wavelength data
KRA-03
Identification and Characterization of Indole and Oxindole Alkaloids from Leaves of Mitragyna speciosa Korth Using Liquid Chromatography-Accurate QToF Mass Spectrometry
December 9, 2015
•
Need precision and accuracy to demonstrate compliance with the SMPR.
KRA-04
LC/MS Method for the Identification of Mitragyna speciose (Kratom) and
December 9, 2015
•
Feedback on recoveries outside the SMPR Demonstration of precision data
•
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Quantitation of Mitragynine Using Linear Ion Trap Mass Spectrometer
•
Additional details around sample preparation Clarification of ability to measure 7-OH Clarify the procedure used to gather accuracy data Calibration curve range needs to be defined.
•
•
•
ACTION ITEMS:
1. Staff: Send notification to method authors respectively of the ERP decision and relevant ERP’s recommendations for each Kratom method to be considered for First Action Official Methods status.
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AOAC Stakeholder Panel on Dietary Supplements Report on the 3 rd SPDS Expert Review Panel Session
STAKEHOLDER PANEL ON DIETARY SUPPLEMENTS EXPERT REVIEW PANEL ON SPDS INGREDIENTS – ALOIN, CINNAMON, AND TEA
METHODS FOR CONSIDERATION: Conclusion: The Expert Review Panels reviewed one (2) aloin methods, one (1) cinnamon method, and two (2) tea methods, which were submitted in response to the Call for Methods. Methods Reviewed: Each aloin, cinnamon and tea method collected by AOAC for consideration by this ERP was assigned a set of reviewers. The decisions of the August 2, 2016 ERP are shown below.
2
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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
3
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AOAC Stakeholder Panel on Dietary Supplements Report on the 3 rd SPDS Expert Review Panel Session
Cinnamon Method Reviews and Decisions Cinnamon ERP Members Present: Brian Schaneberg, Starbuck’s (Chair); Joseph Betz, NIH; Milda Embuscado, McCormick; Martha Jennens, Covance; Tom Phillips, MD Department of Agriculture; Aniko Solyom, GAAS Analytical; Joseph Zhou, Sunshineville Health Products Cinnamon ERP Members Absent: Nour‐Eddine Es‐Safi, Mohammad V University in Rabat; John Finley, LSU (Retired); Darryl Sullivan, Covance Observers: Quanyin Gao, Herbalife, Tetsuhisa Goto, Shinshu University; Gary Jackoway, MIDI; Holly Johnson, Alkemist; Phil Koerner, Phenomenex; Adam Kuszak, NIH; Craig Kunitsky, MIDI; Jasen Lavoie, Pharmachem; Charles Metcalfe, Custom Analytics; Jianming
Tao, Spectrix; Melissa Phillips; NIST, Kurt Young, GNC/Nutra Manufacturing AOAC Staff: Scott Coates, Christopher Dent, Dawn Frazier, Deborah McKenzie AOAC Method # Manuscript Title, Submitter and Reviewer ERP Decisions
Consensus
Decision Date
CIN‐01
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: Provide exclusivity panel data Include the C. tamala data Provide the 33 replicates of each based on SMPR Cross reference species names Further explanation on the software Data on choice of marker compounds for each species (reference) Inclusion of the 7 commercially available compounds
MOTION , Embuscado/Phillips, not to move CIN‐01 to First Action. 7 in favor, 0 opposed, 0 abstentions. The motion passed. MOTION, Jennens/Embuscado to accept the First Action recommendations for CIN‐01 as presented. 7 in favor, 0 opposed, 0 abstentions. The motion passed.
Identification of Selected Cinnamomum spp.Bark in Dietary Supplement Raw Materials and/or Finished Products‐ GasChromatography with Flame Ionization Detection After Hydrodistillation Submitted by: Craig Kunitsky, MIDI Primary Reviewer: Tom Phillips, MDA
08/02/2016
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AOAC Stakeholder Panel on Dietary Supplements Report on the 3 rd SPDS Expert Review Panel Session
Provide representative chromatograms
Tea Method Reviews and Decisions Tea ERP Members Present: Brian Schaneberg, Starbuck’s (Chair); Tetsuhisa Goto, Shinshu University; Martha Jennens, Covance; Holly Johnson, Alkemist Labs; Phil Koerner, Phenomenex; Melissa Phillips, NIST; Tom Phillips, MD Department of Agriculture; Aniko Solyom, GAAS Analytical; Kurt Young, GNC/Nutra Manufacturing Tea ERP Members Absent: Nour‐Eddine Es‐Safi, Mohammad V University in Rabat; John Finley, LSU (Retired); Darryl Sullivan, Covance Observers: Joseph Betz, NIH; Milda Embuscado, McCormick; Quanyin Gao, Herbalife; Gary Jackoway, MIDI, Craig Kunitsky, MIDI, Adam Kuszak, NIH; Jasen Lavoie, Pharmachem; Charles Metcalfe, Custom Analytics; Jianming Tao, Spectrix; Joseph Zhou; AOAC Staff: Scott Coates, Christopher Dent, Dawn Frazier, Deborah McKenzie AOAC Method # Manuscript Title, Submitter and Reviewer ERP Decisions Consensus Decision Date TEA‐01 Analysis of Theanine in Tea (Camellia sinensis) Dietary Ingredients and Supplements by High‐Performance Liquid Chromatography with Post‐Column Derivatization: Single Laboratory Validation Submitted by: Maria Ofitserova, Pickering Labs Primary Reviewer: Melissa Phillips MOTION , T. Phillips/M. Phillips, to move TEA‐01 to First Action. 9 in favor, 0 opposed, 0 abstentions. The motion passed. MOTION, Koerner/Goto to accept the Final Action recommendations as presented. 9 in favor, 0 opposed, 0 abstentions. The motion passed. The ERP voted to move this TEA‐01 to First Action Official Methods Status. The ERP voted that the following must be completed prior to Final Action consideration: Expanded matrix testing data for chewables and gummies Analyte stability temperature during sample prep Guidance on sample prep ‐ how much sample to use? Check glycine‐dimer as possible internal standard Provide calibration curve and the chromatogram of the standard
08/02/2016
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AOAC Stakeholder Panel on Dietary Supplements Report on the 3 rd SPDS Expert Review Panel Session
TEA‐02
The ERP voted not to move TEA‐02 to First Action Official Methods Status at this time. The ERP voted that the following must be completed prior to another First Action consideration: Low level accuracy study and the precision study Other matrices in SMPR that are not addressed Add catechin gallate and methyl xanthenes Address gallic acid interference. Change blank matrix for recovery study Confirm sample prep temperature impact Filtration step validation
MOTION , Koerner/Johnson, not to move TEA‐02 to First Action. 10 in favor, 0 opposed, 0 abstentions. The motion passed. MOTION, Solyom/M. Phillips to accept the First Action recommendations for TEA‐02 as presented. 9 in favor, 0 opposed, 0 abstentions. The motion passed.
Determination of Catechins and Caffeine in Camillia sinensis Raw Materials, Extracts, and Dietary Supplements by HPLC‐UV: Single‐ Laboratory Validation Submitted by: Jana Hildreth Primary Reviewer: Aniko Solyom
08/02/2016
Action Items: AOAC staff to inform method authors of outcomes, including follow up actions AOAC staff to give recommendations on Aloin SMPR to SPDS Aloin Working Group
6
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STAKEHOLDER PANEL ON DIETARY SUPPLEMENTS EXPERT REVIEW PANEL ON SPDS INGREDIENTS – LUTEIN and TURMERIC
EXECUTIVE SUMMARY: The Expert Review Panels reviewed two (2) lutein methods and two (2) turmeric methods, which were submitted in response to the Call for Methods. Each lutein and turmeric method collected by AOAC for consideration by this ERP was assigned a set of reviewers. The decisions of the December 15, 2016 ERP are shown below. CONCLUSIONS: One method for Turmeric was approved as an First Action Official Method of Analysis SM ACTION ITEMS: AOAC staff to inform method authors of outcomes, including follow up actions
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Lutein Method Reviews and Decisions Lutein ERP Members Present: Darryl Sullivan, Covance (Chair); Neal Craft, Craft Technologies; Nour Eddine Es-Safi, Mohammad V University in Rabat; Holly Johnson, Alkemist Labs; Elizabeth Mudge, BCIT; Kate Rimmer, NIST; Aniko Solyom, GAAS Analytical; Hong You, Eurofins; Yang Zhou, Eurofins Lutein ERP Members Absent: Ajai Gupta, CSIR-IIIM Observers: Joseph Betz, NIH; Sanem Hosbas, NIST; Adam Kuszak, NIH; Wagner Lombeida, INEXA; Melissa Phillips, US NIST and AOAC Official Methods Board; AOAC Staff: Scott Coates, Christopher Dent, Dawn Frazier, Deborah McKenzie, Tien Milor, Robert Rathbone AOAC Method # Manuscript Title, Submitter and Reviewers ERP Decisions Consensus Decision Date
MOTION , Zhou/Craft, not to move LUT-01 forward to First Action Official Methods of Analysis status. 8 in favor, 0 opposed 1 abstentions. The motion passed. MOTION , Craft/Mudge, not to move LUT-02 to First Action. 8 in favor, 0 opposed, 1 abstention The motion passed. --- MOTION , Solyom/Johnson, to accept the requirements and recommendations forLUT-02. 8 in favor, 0 opposed, 1 abstention The motion passed.
The ERP voted not to move this method to First Action Official Methods Status because it does not do the required separation of lutein and zeaxanthin.
Quantitative measurement of Beta‐ Cryptoxanthin in Paprika oleoresin, extract and dietary supplements. --- Submitted by: Jyotish Srivastava, OmniActive Health Technologies --- Primary Reviewer: Yang Zhou Secondary Reviewer: Aniko Solyom Determination of Lutein and Zeaxanthin Esters and Their Geometric Isomers in Carotenoid Ester Concentrates Used as Ingredients in Nutritional Supplements: Validation of a Combined Spectrophotometric-HPLC Method --- Submitted by: Luis Levy, INEXA CA ---
12/15/16
LUT-01
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 First Action consideration: -Data on additional matrices, including details on the sample preparation on those matrices -Calibration neat standards -Incorporation of Beta-cryptoxanthin -List specific absorbances of the cis isomers --- The ERP voted that the following should be completed prior to First Action consideration: -Recommend investigating gradient elution -Investigate alternative LC Columns -Clarity on approach to esterified forms -Investigation on isomerization on saponification -Use of an antioxidant material during saponifications
12/15/16
Primary Reviewer: Neal Craft Secondary Reviewer: Hong You
LUT-02
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Turmeric Method Reviews and Decisions Turmeric ERP Members Present: Darryl Sullivan, Covance (Chair); Gerardo Albornoz, McCormick; Neal Craft, Craft Technologies; Nour Eddine Es-Safi, Mohammad V University in Rabat; Holly Johnson, Alkemist Labs; Elizabeth Mudge, BCIT; Melissa Phillips, US NIST and AOAC Official Methods Board; Kate Rimmer, US NIST; Aniko Solyom, GAAS Analytical Turmeric ERP Members Absent: Ajai Gupta, CSIR-IIIM Observers: Joseph Betz, NIH; Sanem Hosbas, NIST; Adam Kuszak, NIH; Wagner Lombeida, INEXA AOAC Staff: Scott Coates, Christopher Dent, Dawn Frazier, Deborah McKenzie, Tien Milor, Robert Rathbone AOAC Method # Manuscript Title, Submitter and Reviewers ERP Decisions Consensus Decision Date
MOTION , Phillips/Johnson, to move TUR- 01 to First Action Official Methods of Analysis status. 6 in favor, 0 opposed, 1 abstention. The motion passed. --- MOTION , Phillips/Johnson, to accept the Final Action requirements for TUR-01. 6 in favor, 0 opposed, 1 abstention. The motion passed. MOTION , Phillips/Johnson, to move TUR- 0 2 to First Action Official Methods of Analysis status. 6 in favor, 0 opposed, 1 abstention. The motion passed. --- MOTION , Johnson/Mudge, to accept the requirements and recommendations for TUR-02. 8 in favor, 0 opposed, 1 abstention The motion passed.
12/15/16
Curcuminoids in Turmeric Roots and Supplements: Method Optimization and Validation --- Submitted by: Elizabeth Mudge --- Primary Reviewer: Melissa Phillips Secondary Reviewer: Holly Johnson
The ERP voted to move this method to First Action Official Methods of Analysis status. --- The ERP voted that the following should be completed prior to the method being granted AOAC Final Action Official Methods of Analysis Status: -Extraction Study -Experiments for specificity -Include list of ingredients from Table 2 in SMPR 2016.003. -Additional data on high level materials (NIST) The ERP voted not to move this method to First Action Official Methods of Analysis status. --- The ERP voted that the following must be completed prior to First Action consideration: -Formal submission of the spike recovery and system suitability (include in submission package) -Clarity around repeatability and precision data -Additional matrices and ingredients -Clarification around methanol extraction comparison to the 80/20 --- The ERP voted that the following should be completed prior to First Action consideration: -Confirm the purity of calibrants
TUR-01
12/15/16
Quantitation of Curcuminoids --- Submitted by: Aniko Solyom ---
Primary Reviewer: Nour Eddine Es-Safi Secondary Reviewer: Elizabeth Mudge
TUR-02
-Analysis of NIST samples -Include specificity data
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STAKEHOLDER PANEL ON DIETARY SUPPLEMENTS EXPERT REVIEW PANEL ON VARIOUS DIETARY SUPPLEMENTS
METHODS FOR CONSIDERATION: The Expert Review Panel (ERP) reviewed methods for the following dietary supplement areas: Free Amino Acids, Protein, Folin‐C, Ginger, Kratom Methods Reviewed: Each method collected by AOAC for consideration by this ERP was assigned a set of reviewers. Methods reviewed included: Philip Haselberger (Abbott Nutrition) ‐ Free Amino Acid Profile and Absence Verification Method by UPLC. Aihua Liu, Michael Landesman, Spencer Carter (Corresponding Author) ‐ Identification of Pea, Rice and Soy Proteins in Raw Materials and Finished Goods using ESI HPLC‐MS/MS. Aihua Liu, Michael Landesman, Spencer Carter (Corresponding Author) ‐ Identification of Milk Proteins in Raw Materials and Finished Goods using ESI HPLC‐MS/MS. Steve Kupina (Constellation Wines), Chris Fields, Mark Roman, Sharon Brunelle. ‐ Determination of Total Phenolic Content Using the Folin‐C Assay: Single Laboratory Validation . Steve Kupina, Chris Fields, Mark Roman, Sharon Brunelle. Determination of Select Nonvolatile Ginger Constituents by HPLC‐DAD. Hong You, Bailey Ireland, Michael Moeszinger, Laura Snow, Scott Krepich, Vivian Takagawa Determination of Mitragynine in Mitragyna speciosa Raw Materials and Finished Products by Liquid Chromatography with UV Detection: Single‐Laboratory Validation. Elizabeth Mudge, Paula Brown
2
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SPDS FREE AMINO ACIDS ERP MEETING – DECEMBER 14, 2017 ERP Members Present:
ERP Members Absent:
Brian Schaneberg, Starbucks Corporation (Chair) Holly Johnson, Alkemist Labs George Joseph, AsureQuality Philip Koerner, Phenomenex Kate Rimmer, NIST Jinchuan Yang, Waters Hong You, Eurofins Garrett Zielinski, Covance
Quanyin Gao, Herbalife David Ji, Covance
Observers: Joseph Betz, US NIH‐ODS; Paula Brown, BCIT; Spencer Carter, Genysis Labs; Christine Casey, US FDA; Philip Haselberger, Abbott Nutrition; Dana Krueger, Krueger Food Laboratories; Mark Lowenthal, NIST; Charles Metcalfe, Custom Analytics; Curtis Phinney, Curtis Phinney CNS; John Szpylka, Mérieux NutriSciences; Tomasz Tuzimski, Medical University of Lublin; Darryl Sullivan, Covance; Aniko Solyom, GAAS Analytical; Jinchuan Yang, Waters Corporation; Kurt Young, GNC/Nutra Manufacturing ; Yanjun Zhang, Herbalife AOAC Staff: Scott Coates, Christopher Dent, Dawn Frazier, Deborah McKenzie, Tien Milor, Robert Rathbone
3
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Free Amino Acids: Method Reviews and Decisions
AOAC Method #
Manuscript Title, Submitter and Reviewers
RP Decisions / Consensus
Title: Free Amino Acid Profile and Absence Verification Method by UPLC Author(s): Phillip Haselberger, Abbott Nutrition Submitted by: Phillip Haselberger, Abbott Nutrition Primary Reviewer: Garrett Zielinski, Covance Laboratories Secondary Reviewer: Holly Johnson, Alkemist Labs
MOTION not to move this method to First Action Official Methods of Analysis ® Status (Johnson/Joseph) 8 in favor, 0 opposed, 1 abstention. The motion carried. Reasoning/Summary: Although the ERP members stated that this is a good method, the members agreed that more compounds should be tested prior to approval as a First Action Official Method of Analysis. Specifically, the author should provide: Data must demonstrate ability to identify and quantitate the free amino acids in Table 1 in the presence of the non‐target compounds of interest in Table 5 of SMPR 2017.011. Clarify the scope – what type of samples is this applicable to? Clarify the sample prep of the different matrices. Linearity should be demonstrated with five‐point validation. Accuracy/Recovery data for ensuring full derivatization. Data demonstrating stability of the derivative amino acids standards and samples.
FAA‐001
4
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SPDS PROTEIN ERP MEETING – DECEMBER 14, 2017 ERP Members Present: Brian Schaneberg, Starbucks Corporation (Chair) Philip Haselberger, Abbott Nutrition Mark Lowenthal, US NIST Curtis Phinney, Curtis S. Phinney, CNS Kate Rimmer, US NIST John Szpylka, Mérieux NutriSciences Tomasz Tuzimski, Medical University of Lublin Jinchuan Yang, Waters Corporation Hong You, Eurofins Garrett Zielinski, Covance Laboratories
ERP Members Absent:
Sneh Bhandari, Mérieux NutriSciences Quanyin Gao, Herbalife Lars Reimann, Eurofins
Observers: Joseph Betz, US NIH‐ODS; Paula Brown, BCIT; Spencer Carter, Genysis Labs; Christine Casey, US FDA; Nour Eddine ES‐ SAFI, Mohammad V University; George Joseph, Assure Quality; Holly Johnson, Alkemist Labs; Philip Koerner, Phenomenex; Dana Krueger, Krueger Food Laboratories; Charles Metcalfe, Custom Analytics; Darryl Sullivan, Covance Laboratories; Aniko Solyom, GAAS Analytical; Kurt Young, GNC/Nutra Manufacturing; Yanjun Zhang, Herbalife AOAC Staff: Scott Coates, Christopher Dent, Dawn Frazier, Deborah McKenzie, Tien Milor, Robert Rathbone
5
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Protein: Method Reviews and Decisions
AOAC Method #
Manuscript Title, Submitter and Reviewers
RP Decisions / Consensus
Title: Identification of Pea, Rice and Soy Proteins in Raw Materials and Finished Goods using ESI HPLC‐MS/MS Author(s): (METHOD AUTHOR’S NAME), Genysis Labs Submitted by: Aihua Liu, Genysis Labs Primary Reviewer: Sneh Bhandari, Mérieux NutriSciences
MOTION to move this method to First Action Official Methods of Analysis ® Status (You/Zielinski) 6 in favor, 2 opposed, 1 abstention. The motion failed. Reasoning/Summary: Dissenters gave their reasoning. Szpylka stated that the method works but he would like to see the proof of the uniqueness of the three peptides that were chosen. Yang stated that he is not happy with the specificity of the method. Also, in the method’s Table 2, some of the molecules are not relevant to this method. Schaneberg explained that some of these issues can be addressed even after the method moves forward; prior to Final Action status. MOTION to move this method to First Action Official Methods of Analysis ® Status (Phinney/Zielinski) 7 in favor, 2 opposed, no abstentions. The motion passed by 2/3 override. Description of the process used to determine the applicability of the two or three peptides, specifically identifying the sources of the non‐animal derived proteins. Clarify the columns used in the method. Clarify the trypsin source and the digestion optimization data. Clarify concentration of urea in method. Formulation details on Matrix A and Matrix B. Provide a statement of orthogonal protein identity. Reproducibility and user feedback MOTION to approve the Final Action Official Methods of Analysis ® Status Requirements as presented (Szpylka/Rimmer) 8 in favor, 0 opposed, 1 abstention. The motion passed. Final Action Requirements:
PRO‐001
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Protein: Method Reviews and Decisions
AOAC Method #
Manuscript Title, Submitter and Reviewers
RP Decisions / Consensus
Title: Identification of Milk Proteins in Raw Materials and Finished Goods Using ESI HPLC‐ MS/MS Author(s): (METHOD AUTHOR NAME) Genysis Labs Submitted by: Aihua Liu, Genysis Labs Primary Reviewer: Hong You, Eurofins Secondary Reviewer: Philip Haselberger, Abbott Nutrition
MOTION to move this method to First Action Official Methods of Analysis ® Status (Haselberger/You) 7 in favor, 2 opposed, 0 abstention. The motion failed. Reasoning/Summary: Dissenters gave their reasoning. Szpylka stated that his concerns are the same concerns he had with PRO‐001 (see above). Yang also stated that his concerns are the same he had with PRO‐ 001. MOTION to move this method to First Action Official Methods of Analysis ® Status (You/Lowenthal) 7 in favor, 2 opposed, no abstentions. The motion passed by 2/3 override. Description of the process used to determine the applicability of the three peptides, specifically identifying the sources of the animal derived proteins. Clarify the columns used in the method. Clarify the trypsin source and the digestion optimization data. Clarify concentration of urea in method. Formulation details on Matrix A and Matrix B. Provide a statement of orthogonal protein identity. Reproducibility and user feedback Add relative retention time to transition parameters and recommend provision of chromatogram. Recommend that author demonstrates that egg white does not inhibit the digestion. MOTION to approve the Final Action Official Methods of Analysis ® Status Requirements as presented (You/Haselberger) 9 in favor, 0 opposed, 1 abstention. The motion passed. Final Action Requirements:
PRO‐002
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SPDS FOLIN‐C ERP MEETING – DECEMBER 14, 2017 ERP Members Present: Brian Schaneberg, Starbucks Corporation (Chair) Nour Eddine ES‐SAFI, Mohammed V University, Morocco Martha Jennens, Covance Laboratories
ERP Members Absent:
Tom Phillips, State of Maryland Department of Agriculture Joseph Zhou, Sunshineville Health Products
Holly Johnson, Alkemist Labs Philip Koerner, Phenomenex Dana Krueger, Krueger Food Laboratories Kate Rimmer, US NIST Aniko Solyom, GAAS Analytical Darryl Sullivan, Covance Laboratories John Szpylka, Mérieux NutriSciences Hong You, Eurofins
Observers: Joseph Betz, US NIH‐ODS; Paula Brown, BCIT; Spencer Carter, Genysis Labs; Christine Casey, US FDA; Philip Haselberger, Abbott; Nutrition; George Joseph, Assure Quality; Mark Lowenthal, US NIST; Charles Metcalfe, Custom Analytics; Curtis Phinney, Curtis Phinney CNS; John Szpylka, Mérieux NutriSciences; Tomasz Tuzimski, Medical University of Lublin; Jinchuan Yang, Waters Corporation; Kurt Young, GNC/Nutra Manufacturing; Garrett Zielinski, Covance Laboratories; Yanjun Zhang, Herbalife AOAC Staff: Scott Coates, Christopher Dent, Dawn Frazier, Deborah McKenzie, Tien Milor, Robert Rathbone
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Folin‐C: Method Reviews and Decisions
AOAC Method #
Manuscript Title, Submitter and Reviewers
ERP Decisions / Consensus
Title: Determination of Total Phenolic Content Using the Folin‐C Assay: Single Laboratory Validation Author(s): Steve Kupina, Constellation Wines; Chris Fields, Applied Foods Sciences LLC; Mark Roman, Tampa Bay Analytical Research Inc.; Sharon Brunelle, Brunelle Biotech Consulting on
MOTION to move this method to First Action Official Methods of Analysis ® Status (Rimmer/Sullivan) 9 in favor, 0 opposed, 0 abstentions. The motion passed.
Final Action Requirements:
Applicability must state that the method is only applicable to samples/extracts with greater than 5% total phenolic content.
o Possibly look at wider range for both product types and phenolic content.
behalf of AOAC INTERNATIONAL Submitted by: Sharon Brunelle
Horat not applicable to this measurement.
Provide LOQ data.
Define the linear dynamic range of the calibration. In must be clear that values are reported in gallic acid equivalents in the method. Clarify the sonification conditions.
Primary Reviewer: Kate Rimmer, US NIST Secondary Reviewer: Tom Phillips, State of Maryland, Department of Agriculture
MOTION to approve the Final Action Official Methods of Analysis ® Status Requirements as presented (Sullivan/Haselberger) 8 in favor, 0 opposed, 1 abstention. The motion passed.
FOL‐004
9
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SPDS GINGER ERP MEETING – DECEMBER 14, 2017 ERP Members Present: Brian Schaneberg, Starbucks Corporation (Chair) Paula Brown, BCIT Anton Bzhelyansky, USP Nour Eddine ES‐SAFI, Mohammad V University, Morocco
ERP Members Absent:
Congmei Cao, Herbalife Yanjun Zhang, Herbalife
Holly Johnson, Alkemist Labs Philip Koerner, Phenomenex Dana Krueger, Krueger Food Laboratories Kate Rimmer, US NIST Aniko Solyom, GAAS Analytical Jinchuan Yang, Waters Kurt Young, GNC/NutraManufacturing Yanjun Zhang, Herbalife
Observers: Joseph Betz, US NIH‐ODS; Spencer Carter, Genysis Labs; Christine Casey, US FDA; Philip Haselberger, Abbott; Nutrition; George Joseph, Assure Quality; Dana Krueger, Krueger Food Laboratories; Mark Lowenthal, US NIST; Charles Metcalfe, Custom Analytics; Curtis Phinney, Curtis Phinney CNS; John Szpylka, Mérieux NutriSciences; Tomasz Tuzimski, Medical University of Lublin; Darryl Sullivan, Covance Laboratories; Aniko Solyom, GAAS Analytical; Hong You, Eurofins; Garrett Zielinski, Covance Laboratories; Yanjun Zhang, Herbalife
AOAC Staff: Scott Coates, Christopher Dent, Dawn Frazier, Deborah McKenzie, Tien Milor, Robert Rathbone
10
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Ginger ERP: Method Reviews and Decisions
AOAC Method #
Manuscript Title, Submitter and Reviewers
ERP Decisions / Consensus
Title: Determination of Select Nonvolatile Ginger Constituents by HPLC‐DAD Author(s): Hong You, Eurofins; Bailey Ireland, Eurofins; Michael Moeszinger, Eurofins; Laura Snow, Phenomenex; Scott Krepich, Phenomenex; Vivian Takagawa, ChromaDex Submitted by: Hong You, Eurofins Primary Reviewer: Aniko Solyom, GAAS Analytical Secondary Reviewer: Paula Brown, BCIT
MOTION to move this method to First Action Official Methods of Analysis ® Status (Krueger/Bzhelyansky) 3 in favor, 7 opposed, 0 abstentions. The motion failed. Reasoning/Summary: Dissenters gave their reasoning in the first action requirements documented below. First Action Recommendations: Separate data to make clear which matrices meet the SMPR’s applicability statement. Properly document methodology for assessing the LOQ. Clarify sample preparation by matrix. Reassess the approach to standard preparation. Compare the wavelength to see if you can get better peak symmetry
GIN‐001
11
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SPDS KRATOM ERP MEETING – DECEMBER 14, 2017 ERP Members Present: Brian Schaneberg, Starbucks Corporation (Chair) Joseph Betz, US NIH‐ODS Paula Brown, BCIT Christine Casey, US FDA Nour Eddine ES‐SAFI, Mohammad V University, Morocco
ERP Members Absent:
Ajai Gupta, CSIR‐IIIM David Pereira, 3Bs Research Group Tom Phillips, State of Maryland Department of Agriculture Yan Hong Wang, University of Mississippi
Holly Johnson, Alkemist Labs Philip Koerner, Phenomenex
Charles Metcalfe, Custom Analytics Darryl Sullivan, Covance Laboratories John Szpylka, Mérieux NutriSciences Hong You, Eurofins
Observers: Spencer Carter, Genysis Labs; Philip Haselberger, Abbott Nutrition; Holly Johnson, Alkemist Labs; Dana Krueger, Krueger Food Laboratories; Mark Lowenthal, US NIST; Curtis Phinney, Curtis Phinney CNS; Kate Rimmer, US NIST; John Szpylka, Mérieux NutriSciences; Tomasz Tuzimski, Medical University of Lublin; Aniko Solyom, GAAS Analytical; Jinchuan Yang, Waters Corporation; Kurt Young, GNC/Nutra Manufacturing; Yanjun Zhang, Herbalife; Garrett Zielinski, Covance Laboratories; Yanjun Zhang, Herbalife AOAC Staff: Scott Coates, Christopher Dent, Dawn Frazier, Deborah McKenzie, Tien Milor, Robert Rathbone
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