Kombucha ERP

Kombucha Method Re-submission Review Form

Submission Date

2018-09-26 15:57:06

Name

Kathy Stenerson

Email

katherine.stenerson@milliporesigma.com

Organization

MilliporeSigma

Has the resubmitted method met the requirements outlined on September 24, 2017? Please provide justification for your answer. If specific requirements were made in the September 24 meeting, please explain how those requirements have been met or not met.

No

Requirements of Sept. 2017 ERP 1. Precision data with at least 8 different kombucha samples, 3 replicates over 2 days. Data from 10 kombucha samples presented. Appear to have been run as single samples on 3 separate days rather than sets of 3 replicates on 2 separate days. Presented the former way, 3 of the 10 samples are >4% RSD. 2. LOQ calculated using the std. dev. of replicate data It is not clear from the data presented that this was done. 3. Units should be expressed as % ABV OK, this has been corrected and a conversion calculation has been included. 4. Accuracy to be established with CRMs a specified in SMPR This has been demonstrated. However accuracy using Kombucha matrix is not demonstrated over the entire analytical range. Is demonstration of accuracy using CRMs only acceptable to the ERP? 5. Linearity should be stated in SLV report Acceptable; as shown 6. Improve presentation of SLV report • Suggest including detail on calculation of LOD and LOQ. • Provide description on how internal standard is incorporated into the determination of the sample reading in ug/mL.