The Identification and Quantitation of Low-Level Compounds for Impurity and Degradation Analyses
Recorded Webinar | John Fetzer | From: Feb 28, 2024 - To: Dec 31, 2024
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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, and 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.
An important factor is that uncertainty, the relative precision of the analysis, is almost always wider as the analyte concentrations get smaller. At trace levels, they may be plus/ minus 20% relative or more.
Areas Covered:-
Why Should You Attend:-
In the development and approval process for new medicines and pharmaceuticals, 2 important tests focus on compounds of very low concentrations –
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.
Analytically this is a requirement for identifying these compounds, assessing their amounts, and assessing the effects on the health of users, on the efficacy of the major components, and the effect on the accuracy and precision of the analysis (usually in terms of interferences)
A variety of chromatographic and spectroscopic techniques are commonly used, often in combination. This webinar covers some example approaches and the validation issues that must be met and maintained that are different and more important than similar assays for compounds at higher concentrations.
Who Will Benefit:-
