The Identification And Quantitation Of Low-Level Compounds For Impurity And Degradation Analyses
Date : 16 April 2019
Time : 01 : 00 PM EST
Duration : 90 Minutes

John C. Fetzer, has had over 30 year experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers on liquid chromatography, 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.

Learning Objectives

  • 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 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.

  • $179.00