化学
过程开发
范围(计算机科学)
新产品开发
仿形(计算机编程)
活性成分
生化工程
产品(数学)
质谱法
纳米技术
工艺工程
色谱法
计算机科学
工程类
业务
药理学
医学
材料科学
几何学
数学
营销
程序设计语言
操作系统
作者
Todd A. Gillespie,Brian E. Winger
摘要
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.
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