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Dual Lab Validation of a Method for the Determination of Fructans in Infant 

Formula & Adult Nutritionals /        

25 Jul 2016

46 

7.

Conclusions 

The submitted new analytical method for the determination of the fructan content in infant formula 

and aldult/pediatric nutritional formula meets the requirements as given in SMPR 2001.002. 

The established LOQ is equal or less than the target value of 0.03%. With the exception of the tested 

sample with a fructan content at LOQ level, the repeatability is much better than the target of 6% and 

the reproducibility is much better than the target of 12%. The average accuracy is  of the method is 

94%. This is within the SMPR target range 90 – 110%. However the range in the 48 accuracy 

experiments was 85 – 114%, just a little bit wider than the target range. The specificity of the method 

is good. 

Last but not least, in this new method no correction whatever has to be made for the type of fructans.  

Reducing and/or non‐reducing fructan end‐groups don’t affect the analytical result. This is a great 

advantage over the AOAC 999.03 method. And just one chromatographic run is needed instead of 

three runs in case of the AOAC 997.08 method

8.

Literature 

1. AOAC official method 997.08. Fructans in food products, ion exchange chromatographic method, first 

action 1997, final action 1999. 

2. AOAC official method 997.08. Measurement of fructan in food, enzymatic/spectrophotometric 

method, first action 1999, final action 2005. 

3. Dennis Cuany, Thierry Bénet, Sean Austin. Development and single‐laboratory validation of a method 

for the determination of total fructans in infant formula. Journal AOAC Int. 2010

93(1)

202‐212 

4. AOAC SMPR 2014.002, Standard method performance requirements for fructans in infant formula and 

adult/pediatric nutritional formula, Approved by AOAC Stakeholder Panel on Infant Formula and Adult 

Nutritionals (SPIFAN). Final Version Date: March 18, 2014. 

5. Appendix L: AOAC Recommended Guidelines for Stakeholder Panel on Infant Formula and Adult 

Nutritionals (SPIFAN) Single‐Laboratory Validation, approved by the AOAC Expert Review Panel on 

Infant Formula and Adult Nutritionals in September 2011. 

VALIDATION REPORT

FOR ERP USE ONLY

DO NOT DISTRIBUTE