12:00 to 13:00 CET
Controlling peptide-related impurities is essential to meet regulatory requirements and ensure product quality. The presence of impurities in drug substances and finished products can pose significant immunogenicity risks to patients, potentially leading to drug recalls or warning letters from Regulatory bodies.
Peptide Impurities Analytical Reference Materials (ARMs) are a newly launched category of USP reference materials to support impurities analysis. These materials are thoroughly characterized using orthogonal techniques such as LC-MS, NMR, and HPLC, enabling accurate primary structure elucidation and precise detection of impurities to help ensure the quality of peptide drugs. USP is pleased to present a webinar that will focus on USP products and solutions including reference standards, ARMs, and documentary standards, to help ensure the quality of peptide therapeutics.
After the presentation, you will:
Gain a deeper understanding of USP peptide product families
- API Reference Standards & monographs – Ensure identity, purity, and potency of synthetic peptides
- Related Impurity Standards – Support impurity profiling and regulatory compliance
- Analytical Reference Materials (ARMs) – Facilitate method development and validation
Understand the critical role of reference materials
- Essential for process development, method validation, and compendial method suitability
- Enhance accuracy, reproducibility, and regulatory compliance in peptide analysis
Key analytical challenges and techniques
- Selection of robust analytical methods for peptide quality assessment
- Advanced characterization techniques to ensure structural integrity, purity, and stability
- Aligning methods with compendial and regulatory expectations for consistent quality assurance
This webinar promises to be an informative session for anyone involved in peptide drug development and quality assurance.