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- W4211013687 abstract "This chapter focuses on a fundamental description of the chemical and physical properties of excipients, the associated characterization methods, and implications for formulation and processing of drug products. It provides an introduction to the current methodologies and excipient properties that are significant for the development of a commercial drug product. The chapter presents detailed descriptions of excipient stability and impurities as well as material variability that can influence drug product performance. Some common reactive excipient impurities include peroxides, reducing sugars, aldehydes, organic acids and esters, heavy metals and trace metals, nitrates/nitrites, and free radicals. Compendial test methods contained in detailed pharmacopeia monographs are readily available. The chapter also discusses the sources of impurities, potential chemical interactions with active pharmaceutical ingredients (API), and analytical methods to measure impurities at trace levels. Comprehensive knowledge of excipients structure and function along with an understanding of the stability soft spots of the drug leads to robust drug product development." @default.
- W4211013687 created "2022-02-13" @default.
- W4211013687 creator A5018929375 @default.
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- W4211013687 date "2016-10-04" @default.
- W4211013687 modified "2023-09-23" @default.
- W4211013687 title "Excipient Characterization" @default.
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- W4211013687 doi "https://doi.org/10.1002/9781118992432.ch1" @default.
- W4211013687 hasPublicationYear "2016" @default.
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