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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.
SRM 3257 is not listed under materials in the experimental section.
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.
In principle yes, though several Validation Parameters doesn't fulfill teh requirements
of 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.
In principle yes, though several Validation Parameters doesn't fulfill teh requirements
of the SMPR
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?
already answered
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