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FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
2
Validation study design is not described so though repeatability and reproducibility data are listed for SRM
1849a it is not clear how reproducibility data were obtained or how many samples were analyzed.
Method Clarity:
Method is clearly written and should be easy to follow; unfortunately the validation study and results are
not well described making it difficult to make comparison with SMPR
Pros/Strengths:
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3 procedures described are capable of analyzing all amino acids specified by SPMR.
•
Hydrolysis procedures are well known and proven to be effective
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The method uses commonly available instrumentation and is easy to implement
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Fast chromatographic analysis
Cons/Weaknesses
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Data for only a single matrix are presented – SRM 1849a
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No SPIFAN matrixes were used
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Full validation results are not presented
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Need at least 6-point calibration curves for all amino acids covering wider ranges (right now, 3-point for
Cysteic acid and Methionine Sulfone, 6-ponit for Tryptophan and 5-point for all other amino acids)
Supporting Data
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General Comment:
-
Method Optimization:
•
Performance Characteristics:
Analytical Range:
Not stated
Amino-03 Review Forms