Hostname: page-component-586b7cd67f-dsjbd Total loading time: 0 Render date: 2024-11-30T21:21:23.452Z Has data issue: false hasContentIssue false
  • English
  • Français

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
Get access Rights & Permissions [Opens in a new window]

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

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Aguiar, A. J., Krc, J., Kinkel, A. W., and Samyn, J. C. (1967). J. Pharm. Sci. 56, 847–853.CrossRefGoogle Scholar
Byrn, S. R. (1982). Solid State Chemistry of Drugs (Academic, New York), pp. 3–27.Google Scholar
DeVilliers, M. M., van der Watt, J. G., and Lotter, A. P. (1991). Drug Develop. Indust. Pharm. 17, 1295–1303.CrossRefGoogle Scholar
Florence, A. T., Salole, E. G., and Stenlake, J. B. (1974). J. Pharm. Pharmac. 26, 479–480.CrossRefGoogle Scholar
Gabe, E. J., Page, Y. L., and Lee, F. L. (1981). Acta Cryst. B 37, 197–200.CrossRefGoogle Scholar
Haleblian, J., and McCrone, W. (1969). J. Pharm. Sci. 58, 911–929.CrossRefGoogle Scholar
Haleblian, J. (1975). J. Pharm. Sci. 64, 1269–1288.CrossRefGoogle Scholar
Klug, H. P., and Alexander, L. E. (1974). X-Ray Diffraction Procedures for Polycrystalline and Amorphous Materials (Wiley, New York), 2nd pp. 94–95 486–487Google Scholar
Ludlam, J., Jacobs, B., and Predecki, P. K. (1991). Adv. X-ray Anal. 29, 625–628.Google Scholar
Lachman, L., Lieberman, H. A., and Kanig, J. L. (1976). The Theory and Practice of Industrial Pharmacy (Lea & Febiger, Philadelphia), PP. 467–485.Google Scholar
Suryanarayanan, R. (1990). Powder Diffr. 5, 155–159.CrossRefGoogle Scholar