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1. Are the definitions
specified in the SMPR used
and applied appropriately in
the supporting
documentation (manuscripts,
method studies, etc...)? If not,
please explain the differences
and if the method is impacted
by the difference.
Yes. A single lab validation was done. Not all of the analytes in the SMPR were
covered.
2. Is there information
demonstrating that the
method meets the SMPR
Method Performance
Requirements using the
Reference Materials stated in
the SMPR? If not, then
specify what is missing and
how this impacts
demonstration of
performance of the method.
In the single lab validation three of the four reference materials were used. The
supporting data demonstrates selectivity, repeatability, ruggedness and linearity. LOD
and LOQ are mentioned, but no supporting data is provided. A few of the repeatability
results were out of the specified range of the SMPR.
3. Is there information
demonstrating that the
method performs within the
SMPR Method Performance
Requirements using the
Reference Materials stated in
the SMPR? If not, then
specify what is missing and
how this impacts
demonstration of method
performance.
Yes, the data meets SMPR method performance requirements for three of four
reference materials were used. No other matrices were used as outlined in the SMPR.
4. Is there information
demonstrating that the
method performs within the
SMPR Method Performance
REquirements table
specifications for all analytes
in the SMPR applicability
statement? If not, please
specify what is missing and
whether or not the method's
applicability should be
modified.
This method covers six of the seven catechins outlined in the SMPR. All of the others
might be able to be detected with the exception of Theanine. Work would need to be
done to show that they could be added to the analysis successfully.
1. Based on the supporting
information, were there any
additional steps in the
evaluation of the method that
indicated the need for any
additional precautionary
statements in the method?
A statement about chemical safety needs to be added at a minimum.