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PMID: 33368259
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Major Applications Biosimilar development Confirms structural equivalence between innovator and generic GLP-1 products, including sequence and modifications Impurity profiling Identifies and characterizes process-related and degradation impurities at trace levels Stability studies Monitors degradation pathways such as oxidation, deamidation, and truncation over time Formulation development Ensures compatibility of GLP-1 peptides with excipients and delivery systems Regulatory submissions Provides critical analytical data required for IND, NDA, and ANDA filings Regulatory Importance Required by global regulatory agencies such as the U.S
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