Whitepaper: Content uniformity method development
Posted: 3 February 2014 | Cobalt Light Systems
Dr. Carl Anderson of Duquesne University, Pittsburgh, USA has written a white paper about developing transmission Raman methods for content uniformity analysis as an alternative to HPLC analysis.
Transmission Raman Spectroscopy has significant potential for reducing costs and time for routine regulated testing of batches produced in pharmaceutical factories. This white paper covers many aspects of the implementation and design of such a method. As well as discussing the processes and considerations for developing good methods, the author contemplates approaches for regulatory submissions for alternate release. An alternate method to replace a stability indicating HPLC content uniformity method is described.
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