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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 an acceptable approach with its backing by validation and documentation ensures that these analyses will be acceptable. Reliance on corroborating data and the documentation to show this is the key.