Current Practices and Considerations for a Stability-Indicating Method in Pharmaceutical Analysis
What are the characteristics and relevant considerations for the development and validation of a stability-indicating method?
In the pharmaceutical industry, the demonstration of drug substance (DS) or drug product (DP) stability over the shelf life is an important aspect of the regulatory requirements.
Analytical Strategies in the Development of Generic Drug Products: The Role of Chromatography and Mass Spectrometry
A discussion of active pharmaceutical ingredient (API) selection, drug product development, and mass spectrometry instrumentation