SPDS Lutein and Turmeric ERPs

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? 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. 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  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? specify the needed revisions.

No. No reference material was used in the validation.

No. Only total beta‐cryptoxanthin was reported.

No.

No. System suitability is needed for beta‐cryptoxanthin in all matrices. It can be  performed with beta‐cryptoxanthin standard.

No. No system suitability was performed in validation.

Yes

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. 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  trans isomers of beta‐cryptoxanthin.   No criteria are defined for linearity  requirement and system suitability. LOQ is missing.