SPDS Set 1 ERP Book

CHON-002

Question

Response

General

AOAC Method Number:

CHON-002

Isotachophoretic Determination of GA and CS in Dietary Supplements

Method Title:

Method Author(s):

Vaclavikova, E., et al.

Reviewer Name:

Curtis Phinney

This method is based on (cITP), a capillary electrophoretic technique based on ionic mobility, with conductivity and UV (254 nM) detection.

Summary of Method

Method Scope / Applicability:

Applicable to dietary supplements and raw materials.

The technique is very well described in two related papers. The authors investigated the role of economically significant and common impurities in great detail. The method is described fully, with considerable background and supporting information.

General Comments About the Method:

Method Clarity

Rigorous experimental design Addresses significant quality concerns Addresses economic adulterants Simple sample prep and reagents

Pros/Strengths

Validated using alternate guidelines (ICH '95, '96) No explicit system suitability step No inter lab data, 2-day inter day study Supporting Data Extensive supporting data and discussion of interferences. Supporting data may not address all SMPR Exhaustively optimized method. Raw data is not presented in this paper. Performance Characteristics

Cons/Weaknesses

General Comments

Method Optimization

Analytical Range:

< 1% to 100%