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SPIFAN Expert Review Panel Report

March 19, 2014

Final

I.

WELCOME AND INTRODUCTIONS

Darryl Sullivan welcomed all participants to the ERP meeting and introduced the ERP members.

II.

REVIEW ACTIONS FROM PREVIOUS MEETING

Darryl Sullivan reviewed previous actions/items from past meetings.

III.

REVIEW OF METHODS BY EXPERT REVIEW PANEL (ERP) FOR FIRST ACTION

OFFICIAL METHOD

SM

STATUS

For each method, the ERP/Working Group Co-Chairs discussed methods submitted.

Carnitine –

Co‐Chairs:

John Austad (Covance) & Guenther Raffler (CLF-Eurofins)

Choline –

Co‐Chair:

Sneh Bhandari (Silliker) & Nick Cellar (Abbott)

To study directors, methods should be able to detect both carnitine and choline, but evaluate the methods

independently.

IV.

REVIEW OF MODIFICATION FOR OMA# 2011.08 (Vitamin B

12

)

V.

The Expert Review Panel (ERP) reviewed the modification to OMA method 2011.08. The primary

(Christiansen/Sliva) and secondary (Kneeteman) reviewers provided their evaluation along with other

members of the ERP.

This is a new method, it contains significant changes. Should check if it should be major or minor

modification

For AOAC First Action, the method must have SPIFAN SLV data

For publication, reference the previous method

Vote the current modified method as AOAC First Action

HPLC/ULC – have data reflect both HPLC & ULC

Have a dispute resolution method, but keep as a back-up

Caveat – back up method if study director doesn’t want to continue

Re-introduce as a new method

VI.

REPEAL OF FIRST ACTION METHODS

The Expert Review Panel (ERP) members collectively discussed the next steps on the remaining First Action

Official Methods

SM

currently in the SPIFAN system.

Method

Method Title

Reviewer(s)

Vote

Comments

Folate

2011.05 - Folate in Infant Formula

and Adult/Pediatric Nutritional

Formula Optical Biosensor Assay

Sneh Bhandari

Melissa Phillips

*Motion to repeal

Yes- 11/ No-0 /Abstain-1

Method is being used, but no

SLV data to be produced

2011.06 - Total Folates in Infant

Formula and Adult Nutritionals by

Trienzyme Extraction and UPLC-

MS/MS Quantitation: First Action

2011.06

Adrienne McMahon

Matt Sliva for Scott

Christiansen

*Motion to extend

method for one (1) year

Yes- 10/ No-0 /Abstain-1

No further work will be done

Extend method for one(1) year

If method is kept, someone

should take it on

1

st

Action status should have

meaning

o

Proprietary method (single

source)

4

Nucleotides

2011.21 - Development and

Application of an HILIC-MS/MS

Method for the Quantitation of

Nucleotides in Infant Formula

Estela Kneeteman

Min Huang

*Motion to keep

Yes- 11/ No-0 /Abstain-1

Keep as a back-up method

4

ERP PROFILE SUMMARIES

28