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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.
None of the reference materials stated in the SMPR were used. Beta‐cryptoxanthin
from Sigma was used to make the standard solution(s), but there is no indication of
the purity of the standard. On page 4 there is a chromatogram that supposedly the
chromatogram of the beta‐cryptoxanthin standard solution that shows a very
inferior standard purity.
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.
Some, but not enough.
(i) Analytical range: Does not specify exactly: "on the basis of linearity", but the
linear range is 4‐20 ppm, much narrower than the required 0.0005‐100%
(ii) Limit of quantitation: Meets the requirement, but not quite clear how it was
calculated. (Six injections of 1 ppm solution, when the lowest concentration of the
linear range is 4 ppm...)
(iii) Recovery and Repeatibility: meets requirement for the two higher ranges. No
data was provided for the two lower ranges.
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.
No system suitability test, although there is a description in the method for the
preparation of blanks.
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.
NA
4. Based on the supporting
information, is the method written
clearly and concisely? If no, please
specify the needed revisions.
More details and clarifications are needed. Is the chromatogram on page is the
chromatogram of the standard? What is the purity of the standard? How the purity
was determined? (They are usually not stable) What were the storage conditions?
What kind of filters were used? Would be helpful to see the chromatograms of the
samples.
5. Based on the supporting
information, what are the
pros/strenghts of the method?
Relatively simple method.
6. Based on the supporting
information, what are the cons
/weaknesses of the method?
(i) Not quite clear what is the analytical range
(ii) There are data for only two matrices, extracts and beadlets
(iii) No data for dietary ingredients
(iv) Without seeing actual chromatograms, it is hard to judge how good is the
separation.
(v) Only one analyte, no cis/trans separation (minor issue)
IV. General Submission Package