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- W1535368219 endingPage "169" @default.
- W1535368219 startingPage "145" @default.
- W1535368219 abstract "Abstract Capillary electrophoresis (CE) has become a valuable technique in the analytical toolbox for pharmaceutical analysts. CE methods have been successfully applied for identification, assay, purity determination, and chiral separation. ICH guidelines should be followed in meeting regulatory approval if CE methods are used in a registration dossier. Here, the validation parameters required for different analytical procedures are described and a comprehensive overview of CE validation studies presented in literature is given. The harmonized general chapters on CE in the European, Japanese, and United States Pharmacopoeias are discussed. In addition, specific pharmacopoeial monographs prescribing CE methods in the current pharmacopoeias are described and the analytical instructions evaluated." @default.
- W1535368219 created "2016-06-24" @default.
- W1535368219 creator A5009702698 @default.
- W1535368219 date "2008-01-01" @default.
- W1535368219 modified "2023-10-17" @default.
- W1535368219 title "7 Overview of current regulatory guidance" @default.
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- W1535368219 doi "https://doi.org/10.1016/s0149-6395(07)00007-4" @default.
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