Whitepaper/App Note

Poster: An informatics based approach to developing a stability indicating method

Posted: 29 June 2017 | | No comments yet

ACD/Labs discuss two software systems that enables systematic and exhaustive approach towards method development and captures structural, analytical, and process related data…

Significant time and effort is spent on chromatographic method development during drug development. The aim of much of this work is to develop a validated analytical procedure that will measure the API in Drug Substance or Drug Product, separate from impurities, excipients, or degradation products (a stability indicating method).

Development of a stability indicating method is aided by an understanding of the process scheme and efficient communication between departments—from process chemistry to analytical R&D— often located in different geographies. Each group typically uses different systems to capture information, leading to Microsoft Excel and PowerPoint being the common means of communication. While easily accessible, these documents are a poor substitute for systems purpose built to handle complex scientific data, leaving results open to interpretation.

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