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- W3047984964 abstract "Abstract This chapter deals with the validation of assay and impurities methods for “small molecules.” The general principles described here are also generally applicable to “large molecules”; however, more than one test is usually necessary to characterize the potency of macromolecules because their potency is dependent not only on concentration but also on other factors such as three-dimensional structure and posttranslational modifications. The validation of methods to assess the potency and purity of macromolecules is discussed in detail in the later chapters." @default.
- W3047984964 created "2020-08-13" @default.
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- W3047984964 date "2020-01-01" @default.
- W3047984964 modified "2023-09-24" @default.
- W3047984964 title "Assay and impurities: method validation" @default.
- W3047984964 doi "https://doi.org/10.1016/b978-0-08-102824-7.00011-7" @default.
- W3047984964 hasPublicationYear "2020" @default.
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