SPDS Lutein and Turmeric ERPs

The SMPR states 4 USP chemical references and 2 NIST reference materials.  The  method uses 3 Chromadex chemical ref standards and turmeric study materials from  AHP and other sources.

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? 7 . Any general comments about  the method? IV.  General Submission Package V.  Recommendation for the Method

Yes for LOQ, accuracy/recovery, repeatability, and intermediate precision.

No

Yes

Yes

Yes

Validation data indicate good specificity, precision, and accuracy in a variety of  materials. High concentration materials that are common in commerce were not evaluated,  >90% curcuminoids.

A simple rapid method with excellent performance in the matrices evaluated.