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Mass spectrometry for small molecule pharmaceutical product development: A review

✍ Scribed by Todd A. Gillespie; Brian E. Winger

Publisher
John Wiley and Sons
Year
2010
Tongue
English
Weight
518 KB
Volume
30
Category
Article
ISSN
0277-7037

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✦ Synopsis

Abstract

Developing a pharmaceutical product has become increasingly difficult and expensive. With an emphasis on developing project knowledge at an earlier stage in development, the use of information‐rich technologies (particularly MS) has continued to expand throughout product development. Continued improvements in LC/MS technology have widened the scope of utilizing MS methods for performing both qualitative and quantitative applications within product development. This review describes a multi‐tiered MS strategy designed to enhance and accelerate the identification and profiling of both process‐ and degradation‐related impurities in either the active pharmaceutical ingredient (API) or formulated product. Such impurities can be formed either during chemical synthesis, formulation, or during storage. This review provides an overview of a variety of orthogonal‐mass spectrometric methodologies, namely GC/MS, LC/MS, and ICP‐MS, in support of product development. This review is not meant to be all inclusive; however, it has been written to highlight the increasing use of hyphenated MS techniques within the pharmaceutical development area. © 2010 Wiley Periodicals, Inc., Mass Spec Rev 30:479–490, 2011

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