SPDS Set 1 ERP Book

ANTH-003

1. Chromatography is impressive. The usability of LC with DAD, MS, or both detection technologies allows confirmations to occur. 2. Extraction protocol is very simple. 1. No work was reported on the method being able to evaluate the presence of fruits listed in Annex II, Exclusivity Panel; Selected Non-Vaccinium Fruit. 2. Only one of the seven types of sample matrices was studied. While I do expect the method to properly analyze the remaining matrix types, I believe this must be first demonstrated. 3. Some peaks were not fully characterized but were "noted as to their type based on MRM information". The author did mention additional testing on a newer instrument would likely identify the unidentified peaks. Supporting Data Chromatograms show acceptable separation of targeted compounds. No study was performed on evaluating if the method can correctly identify all of the authenticity panel (Annex i) materials in the presence or absence of fruits listed in the exclusivity panel (Annex II) Performance Characteristics Standard calibration curve: 18 to 180 mg/L cyanidin-3- chloride

Pros/Strengths

Cons/Weaknesses

General Comments

Method Optimization

Analytical Range:

LOQ:

N/A for this qualitative method

Accuracy/Recovery

N/A for this qualitative method

Precision (RSDr)

N/A for this qualitative method

Reproducibility (RSDR)

N/A for this qualitative method

No study was performed on evaluating if the method can correctly identify all of the authenticity panel (Annex i) materials in the presence or absence of fruits listed in the exclusivity panel (Annex II) Safety Review

System Suitability

Is the method safe to use as written? No specific usage or safety practices listed Are there any safety concerns with any component, instrument, reagent or instruction of the method? If yes, None were evident outside of handling acids