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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
No. No reference material was used in the validation.
impacts demonstration of
performance of the method.
3. Is there information
demonstrating that the method
performs within the SMPR Method
Preformance Requiements table
No. Only total beta‐cryptoxanthin was reported.
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.
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.
IV. General Submission Package
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 is needed for beta‐cryptoxanthin in all matrices. It can be
performed with beta‐cryptoxanthin standard.
3. Is there information
demonstrating that the method
No. No system suitability was performed in validation.
system suitability tests and
controls as specified in the SMPR
worked appropriately and as
expected? If no, please specify.
4. Based on the supporting
information, is the method written
clearly and concisely? If no, please
Yes
specify the needed revisions.
5. Based on the supporting
information, what are the
pros/strenghts of the method?
Procedure is well described for each matrix.
Extraction and quantification of beta‐cryptoxanthin in dietary supplement is straight
and simple.
Peaks are well separated in chromatogram.
6. Based on the supporting
information, what are the cons
Not sure if this method is capable to quantify other analytes in the SMPR such as
lutein and zeaxanthin. Not sure if this method is capable to separate the cis and
/weaknesses of the method?
trans isomers of beta‐cryptoxanthin. No criteria are defined for linearity
requirement and system suitability. LOQ is missing.