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How to Develop a Scalable Metals Removal Process in Chemistry

22 March 2017

We are often asked, just how practically do we go from a batch of OOS metal contaminated product, to one that is metal free? In this application note, Biotage demonstrates how to use the metal scavenging screening test kit to develop a scalable metals removal process for an API.

 

Many people are aware of the need to remove metals. Harmonized ICH Q3D guidelines mean that all known and potential sources of elemental impurity in pharma must be risk assessed and if necessary, controlled.

The purpose of any good screening experiment is to eliminate unsuitable candidates. We screened a suite of scavengers to identify the strongest metal scavenger for the job, scaled our 1 gram quick and small screening experiment 50 times and presented our results.

For more information about staying ahead of the compliance curve and getting the best tips for your method development, contact your local Biotage representative.

Biotage has been a trusted supplier of highly efficient metal scavenging adsorbents to pharma for over 15 years, and has developed a comprehensive self-guiding screening kit and documentation package for scavengers to help clients stay current and future proof their processes. 

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