The Identification and Quantitation of Low-Level Compounds for Impurity and Degradation Analyses
John C. Fetzer has had over 30 years of experience in method development, supervised a large analytical laboratory for over a decade, and has presented numerous courses on compliance. He has authored or co-authored over 100 peer-reviewed papers on analytical chemistry, has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry.
Low-level compound analysis has many differences from that of the more common analyses aimed at major components. The requirements for accuracy and precision are different. Selectivity to differentiate very similar compounds, such as isomers of the various types – substituent positional, optical, alkyl are some – becomes critical since these may differ in toxic effects.
The need for definitive qualitative analyses and a detailed description of how each low-level component has been identified and verified are added requirements. This usually includes a combination of chromatography and spectroscopy, comparison to known compounds, the use of spiked samples, and other specific and complicated approaches.
- 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
Course Level - Intermediate or Advanced
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
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. Identifying and quantitating minor components is mandatory. The use of a valid approach with its backing by validation ensures that these analyses will be acceptable. Reliance on corroborating data and the documentation to show this is the key.