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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.
The SMPR states 4 USP chemical references and 2 NIST reference materials. The
method uses 3 Chromadex chemical ref standards and turmeric study materials from
AHP and other sources.
3. Is there information
demonstrating that the method
performs within the SMPR Method
Preformance Requiements table
specifications for all analytes in the
SMPR applicability statement? If
not, please specify what is missing
and whether or not the method's
applicaiblity should be modified.
Yes for LOQ, accuracy/recovery, repeatability, and intermediate precision.
1. Based on the supporting
information, were there any
additional steps in the evaluation
of the method that indicated the
need for any addional
precautionary statements in the
method?
No
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/strenghts of the method?
Validation data indicate good specificity, precision, and accuracy in a variety of
materials.
6. Based on the supporting
information, what are the cons
/weaknesses of the method?
High concentration materials that are common in commerce were not evaluated,
>90% curcuminoids.
7 . Any general comments about
the method?
A simple rapid method with excellent performance in the matrices evaluated.
IV. General Submission Package
V. Recommendation for the Method