What are the characteristics and relevant considerations for the development and validation of a stability-indicating method?
Arindam Roy
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Articles by Arindam Roy
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.
![Roy figure 5-[41827930]-{585410}-746304-1416911904998.gif](https://cdn.sanity.io/images/0vv8moc6/chroma/5e8a7a8b42be4c1287e42a9e19c61a898804cfe5-700x592.gif?w=350&fit=crop&auto=format)
A discussion of active pharmaceutical ingredient (API) selection, drug product development, and mass spectrometry instrumentation
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Analytical Strategies in the Development of Generic Drug Products: The Role of Chromatography and Mass SpectrometryPublished: October 1st 2011 | Updated:
Current Practices and Considerations for a Stability-Indicating Method in Pharmaceutical AnalysisPublished: March 1st 2014 | Updated:
Current Practices and Considerations for a Stability-Indicating Method in Pharmaceutical AnalysisPublished: August 1st 2014 | Updated:
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