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Efficient Management of Extractable & Leachable Data in Process Development
EP34430
Poster Title: Efficient Management of Extractable & Leachable Data in Process Development
Submitted on 05 Nov 2020
Author(s): Sanji K. Bhal, Joe DiMartino
Affiliations: Advanced Chemistry Development, Inc. (ACD/Labs) 8 King Street East, Suite 107. Toronto, ON, Canada. M5C 1B5
Poster Views: 65
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Poster Information
Abstract: In this presentation, we introduce a CMC decision support application (Luminata®) built to help project teams address the challenge of effective data management across product development. Luminata offers the capability for scientists investigating product enclosure systems to easily construct E&L study maps from data processed in the software of their choice. The software provides an interface for all E&L data to be assembled and connected for easy visual comparison and decision support.Summary: E&L contains large amount of analytical datasets and chemical information of all impurities associated to each study. Luminata’s ability to be configurable, allows it to handle each step within the extractable and leachable process, to store all meta data for each compound found in the study with its corresponding data.References: ACD/Labs would like to thank
Dr. Valter Russo, Director, Zirkon Ltd.
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