SPDS Lutein and Turmeric ERPs

Reference standards were acquired from a different vendor (Chromadex) than those  listed in the SMPR; however, purity of standards was evaluated by qNMR and is  therefore sufficient. Matrix reference materials listed in SMPR were not used in this study (although they  are not yet available from NIST).

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. IV.  General Submission Package

LOQs reported: 0.3 mg/g (0.03%) for BDMC and DMC 1.6 mg/g (0.16%) for CUR SMPR states 0.1%; met for BDMC and DMC, slightly high for CUR

Recovery reported: 96.6‐103.3% SMPR states 95‐110%; met

Analytical ranges reported:  0.097‐0.943% for BDMC (1‐120 ug/mL cal range) 0.056‐8.096% for DMC (1‐100 ug/mL cal range) 0.377‐88.21% for CUR (5‐300 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 reported in supporting information are within range in SMPR (LT 5% at 0.1‐ 50%; LT 3% at >50%) with one exception.  BDMC at 0.373% in a tablet has RSDr of  5.5%.

No.

Yes (precision <5% for replicate samples throughout the run)

Yes (table 2 of supplemental information)

Yes; will likely need to be reformatted from existing publication and supplemental  information into a single document for ease of reader