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FOR EXPERT REVIEW PANEL USE ONLY
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3
Accuracy/Recovery:
Analysis of bound sources of carnitine and choline analyzed in duplicate over three
days gave average recoveries of 104.6% for acetylcholine, 96.7% for phosphatidylcholine, and
104.1% for acetylcarnitine.
Precision (RSD
r
):
An overall repeatability for free and total choline of 1.9 and 2.3 %RSDr, while the overall
Intermediate precision obtained for free and total choline was 2.4 and 2.7 %RSDINT, respectively.
Free and total carnitine had an overall repeatability of 2.9 and 2.7 %RSDr, while the overall
intermediate precision obtained for free and total carnitine was 3.3 and 3.1 %RSDINT,
respectively
Reproducibility (RSD
R
):
•
System suitability: No specific data provided about system suitability other than calibration data and
ion ratios of transitions.
Recommendation:
1.
The method meets all the SMPR requirements for choline analysis listed in the SMPR 2012.13. The
ERP may consider the method for the analysis of free and total choline for First action method.
2.
The method meets all requirements of SMPR (2012.010) for analysis of free and bound carnitine
except its inability to distinguish between L- and D-carnitine. The ERP may have to decide whether
the requirement stated in the SMPR of reporting results as L-carnitine can be over looked or is it
too important for further consideration of the method. 0.6-1.3% contamination by D-carnitine in L-
carnitine pharmaceutical preparation have been reported.
Chol-08 Review Forms