Poster: An informatics based approach to developing a stability indicating method
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.
This poster is restricted - login or subscribe free to access
Thank you for visiting our website. To access this content in full you'll need to login. It's completely free to subscribe, and in less than a minute you can continue reading. If you've already subscribed, great - just login.
Why subscribe? Join our growing community of thousands of industry professionals and gain access to:
- bi-monthly issues in print and/or digital format
- case studies, whitepapers, webinars and industry-leading content
- breaking news and features
- our extensive online archive of thousands of articles and years of past issues
- ...And it's all free!
Related content from this organisation
- Guide to Informatics & Data Integrity
- ACD/Labs: empowering data-driven decisions
- Product Hub: High-throughput experimentation made easier with Katalyst D2D
- Application note: Improving the efficiency of catalyst screening in drug substance development
- Application Note: Tracking fate and purge of impurities and calculating carryover