The Identification and Quantitation of low-level compounds for Impurity and Degradation Analyses

Instructor: John Fetzer
Product ID: 705987
Training Level: Intermediate
  • Duration: 90 Min
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.
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Why Should You 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 Webinar:

  • 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

Who Will Benefit:

  • Lab Chemists
  • Lab Managers
  • Lab Technicians
  • Lab Analysts
  • Industries into Compliance Methodology (Biotech, Pharma) Companies into Environmental Compliance or EPA
Instructor Profile:
John Fetzer

John Fetzer
Consultant, Fetzpahs Consulting

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 Bio analytical Chemistry.

Topic Background:

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.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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