SPDS Lutein and Turmeric ERPs

General Information

Reviewer Name:

Holly Johnson

Email:

holly@alkemist.com

Organization:

Alkemist Labs

Method Reviewed:

TUR‐01

Method Title:

Curcuminoids in Turmeric Roots and Supplements:  Method Optimization and  Validation

Applicable SMPR

2016.003

I.  Summary

Summary of Method:

Presented is a validated HPLC‐UV method for quantitation of individual curcuminoids  in turmeric raw materials and finished products.  Method parameters were modified  in response to a previous ERP; extraction and separation have been optimized, with  extraction solvent and column temp being significant factors.  Factorial studies were  used to guide optimization and a Single Lab Validation was performed on 12  materials with the modified method.

1.  Does the Applicability of the  Method Support the Applicability  of the SMPR?  If not, please explain  what is missing. II.  Review of the Method Only 2.  Does the analytical technique(s)  used in the method meet the  SMPR?  If not, please specify how it  differs from what is stated in the  SMPR. 3.  Are the definitions specified in  the SMPR used and applied  appropriatly in the method?  If no,  please indicate how the terms are  used. 4.  Does the method, as written,  contain all appropriate precautions  and warnings related to the  method's regaents, components,  instrumentation, or method steps  that may be hazardous?  If no,  please suggest wording or  option(s). 1.  Are the definitions specified in  the SMPR used and applied  appropriately in the supporting  documentation (manuscripts,  method studies, etc…)?  If not,  please explain the differences and  if the method is impacted by the  difference.  

Yes

Yes

Yes

N/A

III.  Review of Information in Support of the Method

Yes