AOAC SPIFAN Nutrients ERP-Final Review (Jan. 2019)

FOR EXPERT REVIEW PANEL USE ONLY NOT FOR DISTRIBUTION

Cons/Weaknesses None

General Comment(s) All required supporting data required to establish method, accuracy, repeatability and reproducibility available.

Method Optimization Performed as a part of SLV. The optimization data and validation approved by ERP when the method was approved for first action.

Analytical Range meets SMPR, Part of SLV - First action

LOQ meets SMPR, Part of SLV - First action

Accuracy/Recovery meets SMPR, Part of SLV - First action

Precision (RSDr) Repeatability (RSDr) of free carnitine analysis in all of the MLT samples with its level higher than LOQ was found to be in range of 1.6-3.9% against the SMPR requirement of maximum of 8%. RSDr of MLT samples with its levels > LOQ of total carnitine ranged from 1.8-3.9% across the 8 samples thus far lower than the SMPR target of maximum of 8%. Repeatability of the free choline analysis in MLT samples >2.00mg/100g, was found to be in range of 1.7- 3.7% across these samples thus far lower than the SMPR target of maximum of 5-10%. Total choline analysis in all of the MLT samples gave RSDr values ranging from 1.3-3.0%, far lower than the SMPR requirements of maximum of 5-10%. Reproducibility (RSDR) Reproducibility (RSDR) for free carnitine analysis in all of the MLT samples with its levels higher than LOQ was found to be in range of 2.6-6.3% against the SMPR requirement of maximum of 8%. RSDR of MLT samples with its levels higher than LOQ of total carnitine ranged from 3.7-5.8% across the 8 samples thus far lower than the SMPR target of equal or2.00mg/100g was found to be in range of 4.4- 9.1% across these samples thus lower than the SMPR target of maximum of 5-10%. Total choline analysis in all of the MLT samples except one gave RSDR values ranging from 5.2-9.0% thus meeting the SMPR target of maximum 10-15%. But one of the sample (the adult nutritional ready to feed-high fat sample) provided total choline RSDR value somewhat higher than the SMPR requirements