SPIFAN Stakeholder Panel (September 23, 2017)

GLYCIDOL

92

glycidol*** in dry infant formula samples (powder)

glycidol*** in liquid infant formula samples 2 – ≥ 48 µg/kg

Analytical range

15 – ≥ 400 µg/kg

LOD LOQ

N/A

N/A

≤ 15 µg/kg 70-125 %

≤ 2 µg/kg 70-125 %

Accuracy

% RSD r

≤ 22 %

≤ 22 % ≤ 44 %

15-48 µg/kg

> 48 µg/kg

%RSD R

≤ 44 % ≤ 25 % ***analyte content resulting from the determination of bound glycidol.

93 94 95 96 97 98 99

5. System suitability tests and/or analytical quality control:

Suitable methods will include blank check samples, and check standards at the lowest point

and midrange point of the analytical range.

6. Reference Material(s):

Follow ANNEX F : Development and Use of In-House Reference Materials in Appendix F: Guidelines for Standard Method Performance Requirements in the Official Method of Analysis of the AOAC INTERNATIONAL compendium. (http://www.eoma.aoac.org/app_f.pdf)

100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126

7. Validation Guidance :

Appendix L: AOAC Recommended Guidelines for Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) Single-Laboratory Validation , Official Methods of Analysis of AOAC INTERNATIONAL (current edition), AOAC INTERNATIONAL, Rockville, MD, USA.

( http://www.eoma.aoac.org/app_l.pdf)

Method developer must be able to determine recovery of free and bound forms.

Method applicability should be verified by matching assigned values of suitable reference

material(s).

• Suitable reference materials should consist of infant formula that contains 2-MCPD esters, 3-MCPD esters and glycidyl esters that origin from the commonly applied • Free 2-MCPD und 3-MCPD, which typically are not present in significant amounts in infant formulae, should also be present in reference materials but might be introduced • The analyte contents should represent ranges that are commonly present in merchantable products but have to be in minimum equal or bigger than the limits of • As different types of infant formulae might show also very different accessibility to extraction techniques, reference materials should represent merchantable products processing techniques and are not being spiked. by spiking. quantification that are part of this SMPR.

with high demands to analyte extraction

8. Maximum Time-To-Result : No maximum time.

4