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SPIFAN Expert Review Panel Report
September 29, 2015
Final Version
Page 4
IV.
REVIEW OF METHODS BY EXPERT REVIEW PANEL (ERP) FOR FINAL ACTION
OFFICIAL METHOD
SM
STATUS
The Expert Review Panel (ERP) reviewed Two (2) methods for Final Action
Official Methods
SM
status. Zero (0)
methods were recommended to the Official Methods Board (OMB) for Final Action
Official Method
SM
consideration.
Method
Method Title
Reviewer(s)
Vote
Comments
Minerals &
Trace
Elements
OMA# 2011.14
(MTE-01) -
2013 AOAC INTERNATIONAL
AOAC Official Method
2011.14 Calcium, Copper,
Iron, Magnesium,
Manganese, Potassium,
Phosphorus, Sodium, and Zinc
in Fortified Food Products
Sneh Bhandari
Brendon Gill/
Harvey Indyk
Don Gilliland
Bill Mindak (Moved)
Brendon Gill (Second)
Motion: withdrawn
_________________
Method not recommended
for Final Action status
*Method retains Final
Action
Official Method
SM
status with a change in the
applicability for infant
formula
Copper did not meet SMPR for LOQ
Clarification on LOQ
Need diversity of infant formula
Need justification from ERP on SMPR
Vitamin D
OMA# 2011.11
(VitD-01) -
Vitamin D - Determination of
Vitamin D2 and D3 in Infant
and Adult/Pediatric
Nutritionals and Utilizing
Ultra High Performance Liquid
Chromatography/Tandem
Mass Spectrometry (UHPLC-
MS/MS)
Sneh Bhandari
Brendon Gill/
Harvey Indyk
Jon DeVries (Moved)
Sarwar Gilani (Second)
Yes-2/ No-11/Abstain-2
_________________
Method not recommended
for Final Action status
*Method retains First
Action
Official Method
SM
status
Only one (1) sample was used for D
2
Exclude HPLC
8/16 had performance issues
Next steps
o
Open call for methods
o
Discuss with stakeholders
IV.
REVIEW OF METHODS BY EXPERT REVIEW PANEL (ERP) FOR REPRODUCIBILITY TESTING
The ERP will collectively discuss the methods and select a single method to move forward through the AOAC SPIFAN
process for reproducibility testing.
Method Evaluation Forms - Methods processed via the numbering system:
Method
Method Title
Number Voting
Comments
Carnitine/ Choline
OMA# 2014.04 (
Car n-05) - Single Laboratory
Validation of CARN-05: Determination of Free and
Total Carnitine and Choline in Infant Formulas and
Adult Nutritional Products
1204
OMA# 2015.10 (
Car n-07) - Analysis of Free and Total
Carnitine and Choline in Infant Formula and Adult
Nutritionals
~Move to reproducibility testing
1207
Chloride
OMA# 2015.08
(Chlor-02) - Infant Formula and Adult
Nutritionals Chloride by Potentiometry
~Move to reproducibility testing
1413
CAIQ & Nestle to work together to
get one method
OMA# 2015.07
(Chlor-04) Chlorine in Infant Formula
and Adult/Pediatric Nutritional Formula by
Potentiometric Titration
1411
Folate
OMA# 2013.13
(Fol-21) - Single-Laboratory Validation
- Free Folates in Infant Formula and Adult/ Pediatric
Nutritional Formula by UHPLC-UV
No Vote
Method doesn't do bound folate
Nestle & Silliker to work together
and write up a document
explaining - should harmonize.
Exact match label compound
define "total"
If you leave in "use internal
standard" remove the compound
Defer to March 2016
ERP PROFILE SUMMARIES
47