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2. Does the method contain
system suitability tests or
controls as specified by the
SMPR? If not, please indicate
if there is a need for such
tests or controls and which
ones.
Yes, it contains suitability tests applicable to the SMPR.
3. Is there information
demonstrating that the
method system suitability
tests and controls as
specified in the SMPR worked
appropriately and as
expected? If no, please
specify.
Yes.
4. Based on the supporting
information, is the method
written clearly and concisely?
If no, please specify the
needed revisions.
Yes, the method is written in clearly and concisely, and thoroughly elucidates the
necessary steps and materials needed.
5. Based on the supporting
information, what are the
pros/strengths of the
method?
The pros of this method are that it utilizes a rugged, precise method that has been a
methodology of choice for amino acid analysis. The post-column derivatization step
eliminates the problems associated with pre-column derivatization.
6. Based on the supporting
information, what are the
cons/weaknesses of the
method?
The cons/weaknesses are those that are encountered with the general
methodology/instrumentation used; long run times, staining from ninhydrin reagent, use
of instrumentation/columns/buffers that are only useful for a narrow purpose.
7. Any general comments
about the method?
In general this method would be ideal for labs that are already doing free amino acid
testing using post-column derivatization HPLC.
Do you recommend this
method be adopted as a First
Action and published in the
Official Methods of Analysis
of AOAC INTERNATIONAL?
Please specify rationale.
Yes, after limitations are discussed and evaluated.