A short course in the systematic validation of HPLC methods. This section covers various aspects of data analysis including how and when external standardization, internal standardization, and the method of standard additions should be used for...
Analytical Training Solutions: Principles of HPLC Validation
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A short course in the systematic validation of HPLC methods. We introduce Quality by Design (QbD) as a laboratory lifestyle described in ICH Q8. QbD translates into more efficient method development, easier validation, more manageable methods in...
A short course in the systematic validation of HPLC methods. We go through the various validation steps in detail. We review the key regulatory requirements from the International Committee on Harmonization (ICH), which also apply to the national...
A short course in the systematic validation of HPLC methods. The validation process is best started with the first injection during method development. We discuss the importance of having an overall plan for the method development / validation /...
A short course in the systematic validation of HPLC methods. We start by taking an overview of the validation process and review some of the key references that will be useful in setting up a validation process. We also discuss the terminology and...
