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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
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
5. Based on the supporting
information, what are the
pros/strengths of the
method?
1. appears to be a simple straight forward HPLC gradient separation with UV detection
2. baseline resolution for all analytes
3. appropriate system suitability included
4. addressing the potential for analyte degradation by inclusion of EDTA in mobile
phase and diluent
6. Based on the supporting
information, what are the
cons/weaknesses of the
method?
1. only includes caffeine of the 3 methyl xanthenes; could it be extended to include
theobromine and thophylline?
7. Any general comments
about the method?
method specifies Ascentis Phenyl 3um 100x3.0mm column; would other Phenyl
columns also work to give equivalent results?
This would give users some flexibility in column selection
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
method applicable to catechins and caffeine per SMPR for Tea