SPDS Lutein and Turmeric ERPs

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.

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.   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.   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? 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. 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. 4.  Based on the supporting  information, is the method written  clearly and concisely?  If no, please  specify the needed revisions. 5.  Based on the supporting  information, what are the  pros/strenghts of the method? 6.  Based on the supporting  information, what are the cons  /weaknesses of the method? IV.  General Submission Package

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.

No

No system suitability test, although there is a description in the method for the  preparation of blanks.

NA

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.

Relatively simple 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)