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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.
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.
Yes. 3 NIST SRMs were used for demonstration of accuracy. Determination of
theanine in all 3 materials was within uncertainty of the assigned values.
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. 3 NIST SRMs were used for demonstration of accuracy. Determination of
theanine in all 3 materials was within uncertainty of the assigned values.
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.
The method only addresses the determination of theanine. Method does not address
determination of catechins, methyl xanthines, or theaflavins.
The method is very specific for theanine and it does not make sense to extend the
applicability to the other analyte groups.
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?
No.