Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability ...

The authors discuss the theory of ion mobility spectrometry, its benefit over HPLC analysis in cleaning verification, and the experimental considerations for method validation and validation. The ...

In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...

Good HPLC methods must satisfy both technical requirements (sensitivity, specificity, linearity, accuracy and precision) as well as business needs (reliability in routine use and a run time ...