The Identification And Quantitation Of Low-Level Compounds For Impurity And Degradation Analyses

In this webinar attendees will learn the impurity and degradation product analyses tests on compounds of low concentrations for Identification and Quantitation.

This webinar covers the 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.

Why you should Attend: 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 combination of chromatography and spectroscopy, comparison to known compounds, the use of spiked samples, and other specific and complicated approaches.

Areas Covered in the Session:

• 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

• Lab Chemists
• Lab Managers
• Lab Technicians
• Lab Analysts
• Industries into Compliance Methodology (Biotech, Pharma) Companies into Environmental Compliance or EPA