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Validity : 15th Apr'24 to 25th Apr'24
The Identification and Quantitation of Low-Level Compounds for Impurity and Degradation Analyses
- Qualitative approaches to identification
- Selectivity of identification
- The use of complementary data
- Peak shape, peak purity, and retention time as validation
- The importance of a standard reference or surrogate
- On-going diligence
Overview of the webinar
In the development and approval process for new medicines and pharmaceuticals, 2 important tests focus on compounds of low concentrations – impurity and degradation product analyses. Analytically this means identifying these compounds and assessing their amounts. A variety of chromatographic and spectroscopic techniques can be used, often in combination. This webinar covers some example approaches and the validation issues that must be met and maintained.
Who should attend?
- Lab Chemists
- Lab Managers
- Lab Technicians
- Lab Analysts
- Industries into Compliance Methodology (Biotech, Pharma)
- Companies into Environmental Compliance or EPA
Why should you attend?
Identifying and quantitating minor components is mandatory. The use of an acceptable approach with its backing by validation and documentation ensures that these analyses will be acceptable. Reliance on corroborating data and the documentation to show this is the key.
- To learn how to have a structured approach to minor component identifications that are the acceptable
- Understanding the validation and documentation needs for the different approaches
- The use of libraries versus manual data interpretation
- Using the interconnection between data
- Completing the cycle – checking that an identification is correct
- On-going strategies
Faculty - Dr.John Fetzer
Dr. John C. Fetzer, PhD offers over 20 years of expertise in Analytical Chemistry, focusing on Polycyclic Aromatic Hydrocarbons, Petroleum and its Products, Chromatography, and UV and Fluorescence Spectroscopy. He offers Analytical Chemistry Consulting Services and Scientific Career Development Consulting services to companies, organizations, and individuals. Dr. Fetzer has over a decade of experience as a supervisor, team leader, trainer, and coach. He has published over 100 peer-reviewed scientific publications, 2 books, and 8 book chapters.
Dr. Fetzer is an American Chemical Society tour speaker, who has participated in over twenty invited lectures at conferences, universities, and government laboratories.