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Studies on the Crystallinity of a Pharmaceutical Development Drug Substance by Stephen J. Byard; Susan L. Jackson; Andrew Smail; Michel Bauer; David C. Apperley is a Chemistry article available to read on EtoBox.

What is Studies on the Crystallinity of a Pharmaceutical Development Drug Substance about?

The crystallinity and amorphous content of a micronized pharmaceutical development drug substance have been independently determined. An evaluation of different techniques for this purpose has been carried out, and it was found that solidstate nuclear magnetic resonance (ss NMR) and X-ray powder diffraction (XRPD) were suitable for the former and latter, respectively. The baseline intensities of X-ray powder diffractograms, associated with the amorphous component of the sample, have been used to detect levels of non-crystalline material greater than 5%w/w with an absolute accuracy of AE3%. ss NMR has been employed to quantify crystalline defects at levels of greater than 3%w/w with an estimated uncertainty of AE2%. It is proposed that such crystalline defects arise from molecular conformational differences that only have a small effect on crystal lattice parameters and, by implication, only have small effects on X-ray powder diffractograms. In both cases the techniques are shown to be highly reproducible and require minimal sample preparation. Excellent linearity is demonstrated for the determination of amorphous material using prepared standards. The present account describes the

Who reads Studies on the Crystallinity of a Pharmaceutical Development Drug Substance?

Author

Stephen J. Byard; Susan L. Jackson; Andrew Smail; Michel Bauer; David C. Apperley

Publisher

John Wiley and Sons; Elsevier ; Elsevier Inc.; Elsevier BV (ISSN 0022-3549)

Published

2005

Language

EN

Field

Chemistry (Physical Sciences)