This course covers USP General Chapter <621> Chromatography, with focus on system suitability parameters and adjustments allowed to the chromatographic system. Additional topics covered in this course are HPLC theory, column selection and practice. Harmonization details will also be discussed. Participants will apply their knowledge to real-world scenarios and examples using the information found in USP chapters.

Subject area:
Drug Products & APIs

Objectives (If applicable):
• Explain the science behind the HPLC technique
• Compare the relevance of USP General Chapter <621> and HPLC tests
• Identify system suitability parameters for HPLC tests
• Describe USP <621> permitted adjustments in a chromatographic system
• Discuss the impacts for Column Chemical Equivalency in USP Monographs
• Summarize practical considerations of an HPLC system

Target Audience (If applicable):
• Analytical lab managers
• Analytical scientists
• QC scientists
• Pharmaceutical scientists• Method validation specialists
• CMC reviewers
• QA specialists
• Chromatography specialists
• Regulatory professionals