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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.
Authors did not use the reference materials recommended by the SMPR.
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.
Analytical range: Submitted method has its analytical range between approximately
0.1 to 100%. The SMPR requires 0.0005 to 100%.
LOQ: Method did not document LOQ.
Recovery: For samples that have their range >1%, the submitted method has 97% as
its recovery, while the SMPR requires recovery as 98‐102%. Note: the definition of
recovery is different between the submitted method and SMPR. Authors established
“Recovery” by comparing the analytical results of commercial samples with values
from suppliers’ Certificate of Analysis, while the SMPR requires comparing the
analytical results from spiked sample with their theoretical value.
Repeatbility: Submitted method has its repeatability RSDr
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. Authors may need to admit that the extinction coefficients in table 1 are not
precisely applicable to this method because they were established at their λmax not
445 nm.
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 contains system suitability tests.
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?
The method is easy to conduct and does not require calibration standards for the
routine quantification. The method has high accuracy for the determination of total
xanthophyll ester contents. Also, the method is robust when cis‐isomers of lutein
and zeaxanthin are present in a significant amount.
6. Based on the supporting
information, what are the cons
/weaknesses of the method?
The method cannot distinguish the esterified and nonesterified forms of
xanthophylls. In addition, this method did not document any information about beta‐
cryptoxanthin.
IV. General Submission Package