SPDS Lutein and Turmeric ERPs

LOQs reported: 0.92 ug/mL (0.09%) for BDMC  1.33 ug/mL (0.13%) for DMC 2.86 ug/mL (0.29%) for CUR

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.  

SMPR states 0.1%; met for BDMC, slightly high for DMC, high for CUR.  *Calculations  to % done without inclusion of methanol density, which would actually make them  higher and further from requirement

No recovery information provided.

Analytical ranges reported:  0.09‐1.66% for BDMC (0.6‐15 ug/mL cal range) 0.39‐10.3% for DMC (1.7‐42 ug/mL cal range) 0.00016‐25.2% for CUR (4‐100 ug/mL cal range) SMPR requests 0.1% to >50%; based on levels in products and the calibration ranges  demonstrated, I have no concern about this method working in this range.   RSDrs for one BDMC test, one CUR test, and 3 DMC tests are outside of the range in  SMPR (LT 5% at 0.1‐50%; LT 3% at >50%).  Values range from 6‐7%.  6 samples were  tested.

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? IV.  General Submission Package

No

No

N/A

Yes

The method is straightforward and relatively simple.  It has been tested on a number  of matrices (as suggested in Table 3 of SMPR) and in the presence of numerous  other botanicals (including 2 from Table 2 of SMPR).