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• W2613453537 abstract "This chapter examines the operation and use of charged aerosol detection (CAD) in a regulated pharmaceutical environment, addresses method development, validation, and transfer, and highlights a few examples illustrating some advantages of using CAD in the pharmaceutical laboratory. Analytical method validation (AMV) is one part of the overall validation process that also includes software qualification, analytical instrumentation qualification (AIQ), and system suitability. During AMV, several analytical performance characteristics are potentially evaluated, including limits of detection (LOD) and limits of quantitation (LOQ), depending upon the requirements of the method. With a CAD dynamic range of four orders of magnitude, determining the LOQ and LOD does not prove to be an issue for most compounds at the 0.1 and 0.05% concentration levels. The ion analysis method selected for the formulation process is typically used in downstream processes when the active pharmaceutical ingredient (API) is monitored to ensure its safety, quality, strength, and purity." @default.
• W2613453537 created "2017-05-19" @default.
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• W2613453537 date "2017-05-12" @default.
• W2613453537 modified "2023-10-16" @default.
• W2613453537 title "Charged Aerosol Detection in Pharmaceutical Analysis" @default.
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• W2613453537 doi "https://doi.org/10.1002/9781119390725.ch10" @default.
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