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Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
Bioanalysis is a sub-discipline of analytical chemistry covering the quantitative measurement of xenobiotics (drugs and their metabolites, and biological molecules in unnatural locations or concentrations) and biotics (macromolecules, proteins, DNA, large molecule drugs, metabolites) in biological systems.
Analytical chemistry consists of classical, wet chemical methods and modern analytical techniques. [2] [3] Classical qualitative methods use separations such as precipitation, extraction, and distillation. Identification may be based on differences in color, odor, melting point, boiling point, solubility, radioactivity or reactivity.
An assay (analysis) is never an isolated process, as it must be accompanied with pre- and post-analytic procedures. Both the communication order (the request to perform an assay plus related information) and the handling of the specimen itself (the collecting, documenting, transporting, and processing done before beginning the assay) are pre-analytic steps.
Process analytical chemistry (PAC) is the application of analytical chemistry with specialized techniques, algorithms, and sampling equipment for solving problems related to chemical processes. It is a specialized form of analytical chemistry used for process manufacturing similar to process analytical technology (PAT) used in the ...
All analytical procedures should be validated. Identification tests are conducted to ensure the identity of an analyte in a sample through comparison of the sample to a reference standard through methods such as spectrum, chromatographic behavior, and chemical reactivity. [5] Impurity testing can either be a quantitative test or a limit test.
List of materials analysis methods This page was last edited on 14 November 2023, at 15:12 (UTC). Text is available under the Creative Commons Attribution ...
Summary of analytical methods for chiral analysis Method Brief narrative of principle and application; Chromatographic: Chiral HPLC Chiral HPLC is used to separate enantiomers either by direct or indirect separation mode. Widely employed to check enantiomeric purity, provided the reference standards of the racemate or the two enantiomers are ...
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