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The applicability of powder X-ray diffraction to the quantification of drug substance polymorphs using a model organic system

Published online by Cambridge University Press:  10 January 2013

W. Christopher Kidd ,
Peter Varlashkin  and
Chia-yu Li
W. Christopher Kidd
Affiliation:
Analytical Development Laboratories, Burroughs Wellcome Company, Greenville, North Carolina 27834, USA
Peter Varlashkin
Affiliation:
Analytical Development Laboratories, Burroughs Wellcome Company, Greenville, North Carolina 27834, USA
Chia-yu Li
Affiliation:
Department of Chemistry, East Carolina University, Greenville, North Carolina 27858, USA
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Abstract

With a new emphasis on the control of polymorphism in pharmaceutical production, the need for methods to quantify polymorphic forms has arisen. Techniques using X-ray powder diffraction are increasingly being used to characterize the phases of drug substances that exist in multiple crystal forms. Current methods to identify the polymorphic phases in a drug substance include microscopy, infrared spectroscopy, thermal analysis (DSC/TGA), solid state NMR, and X-ray powder diffraction. Of the aforementioned techniques, X-ray powder diffraction provides the most effective approach to identify and quantify the different crystal phases of a pharmaceutical compound. This work is intended as a guide to the characterization and quantification of an organic crystalline system using X-ray diffraction. The approaches suggested are intended to provide assistance not only from an in-process pharmaceutical manufacturing standpoint, but also for routine quality assurance screening of polymorphic drug substances.

Type
Research Article
Information
Powder Diffraction , Volume 8 , Issue 3 , September 1993 , pp. 180 - 187
Copyright
Copyright © Cambridge University Press 1993

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