Formation of an Unprecedented Impurity during CE-SDS Analysis of a Recombinant Protein

ConclusionsOur study clearly suggested that even though IAM has been used extensively as an alkylation reagent in the traditional non-reducing CE-SDS analysis of monoclonal antibodies and other proteins, alkylation with IAM could potentially lead to additional impurity peak, and therefore complicating analysis. Therefore, before performing CE-SDS and other analyses, the effects of sample preparation procedures on analytical results must be evaluated. For protein X, IAM should be excluded for CE-SDS analysis.
Source: Pharmaceutical Research - Category: Drugs & Pharmacology Source Type: research