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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.
Yes standard curcuminoids (curcumin, demethoxycurcumin and
bisdemethoxycurcumin) were used.
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.
The LOD, LOQ and repeatability requirements were investigated and their
corresponding parameters are reported in the proposed methods. In the
repeatability given results, some points are out of ranges specified in the SMPR.
Parameters concerning recovery and reproducibility are missing.
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?
Yes, recovery and reproducibility performance of the method are to be done.
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 the method include injections of blank and standard samples.
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 the proposed method is clearly and concisely written.
5. Based on the supporting
information, what are the
pros/strenghts of the method?
The method seems to be simple giving a good separation of the three investigated
curcuminoid compounds.
6. Based on the supporting
information, what are the cons
/weaknesses of the method?
Repeatability must be improved
7 . Any general comments about
the method?
No
IV. General Submission Package
V. Recommendation for the Method