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© 2023 MJH Life Sciences™ and Chromatography Online. All rights reserved.
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.
A discussion of active pharmaceutical ingredient (API) selection, drug product development, and mass spectrometry instrumentation