Expert Review Panel for Dietary Supplements

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. method performs within the SMPR Method Performance REquirements table specifications for all analytes in the SMPR applicability statement? If not, please specify what is missing and whether or not the method's applicability should be modified. 3. Is there information demonstrating that the

The SMPR listed four reference materials, three of them (USP 1291504, NIST 3398 and NIST 3399) were used in the studies.

Analytical range: If the analytical range defined in the SMPR is for the total amount of nonvolatile ginger constituents, the method meets the requirements. If the analytical range is for each individual analyte, than the method doesn't meet the requirements.

Limit of Quantitation: met requirements (also see note for II. 3)

Recovery: Spike recovery studies were performed using Galangal and excipient blend as matrices; the recoveries from these matrices met the SMPR requirements. RSDr: Most of the individual analytes met the SMPR's requirement. The reasons for higher RSDr were low concentration, liquid samples and possibly inadequate separation

RSD(R): The RSD(R) for majority of the zingerone and some of the 6-paradol, 6-shogaol and 10-gingerol quantitation was more than 8%.

IV. General Submission Package

IV. General Submission Package 1. Based on the supporting information, were there any additional steps in the evaluation of the method that indicated the need for any additional 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.

No

The SMPR did not specify system suitability criteria, but the presented system suitability data comply with the requirements of USP General Chapter <621>; RSD less or equal 2.0% calculated from 5 replicate injections of the standard preparation.