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Stability indicating HPLC Method for the Determination of Semaglutide Related Substances and Degradation Products Using Aeris™ Peptide XB-C18
Separating impurities in Semaglutide production presents challenges due to the complex nature of peptide-related impurities. These impurities often include D-amino acid isomers, truncated sequences, oxidized or reduced forms and others arising from deamidation, phosphorylation, acylation and glycosylation. To achieve effective separation of these impurities, a systematic methodology and careful selection of the stationary phase is often necessary. Enhanced retention and selectivity are required to distinguish between the numerous peptide impurities that closely resemble one another. For this purpose, an HPLC method of great separative capability was developed using Aeris™ Peptide XB-C18 column. In this application note Forced degradation studies were conducted to assess the stability-indicating nature of the method.
Stability indicating HPLC Method for the Determination of Semaglutide Related Substances and Degradation Products Using Aeris™ Peptide XB-C18
Separating impurities in Semaglutide production presents challenges due to the complex nature of peptide-related impurities. These impurities often include D-amino acid isomers, truncated sequences, oxidized or reduced forms and others arising from deamidation, phosphorylation, acylation and glycosylation. To achieve effective separation of these impurities, a systematic methodology and careful selection of the stationary phase is often necessary. Enhanced retention and selectivity are required to distinguish between the numerous peptide impurities that closely resemble one another. For this purpose, an HPLC method of great separative capability was developed using Aeris™ Peptide XB-C18 column. In this application note Forced degradation studies were conducted to assess the stability-indicating nature of the method.
Stability indicating HPLC Method for the Determination of Semaglutide Related Substances and Degradation Products Using Aeris™ Peptide XB-C18
Separating impurities in Semaglutide production presents challenges due to the complex nature of peptide-related impurities. These impurities often include D-amino acid isomers, truncated sequences, oxidized or reduced forms and others arising from deamidation, phosphorylation, acylation and glycosylation. To achieve effective separation of these impurities, a systematic methodology and careful selection of the stationary phase is often necessary. Enhanced retention and selectivity are required to distinguish between the numerous peptide impurities that closely resemble one another. For this purpose, an HPLC method of great separative capability was developed using Aeris™ Peptide XB-C18 column. In this application note Forced degradation studies were conducted to assess the stability-indicating nature of the method.