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.
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.
This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most cri...
By John C. Fetzer
Compliance under GLP can be difficult. The setting up of a system to monitor the performance of methods and instruments...
By John C. Fetzer
The records in a lab – the logbooks for chemicals, reagents, and calibration solutions, sample preparation, instru...
By John C. Fetzer
Tattoos were always associated with sailors, marines, and bikers. Not today. Over the past few decades, there has been r...
This webinar is for you if you ever find yourself in a difficult emotional situation where a cool head is necessary. Th...
Copyright © 2023 GRC Educators. All Rights Reserved
