High Speed Analysis of Paracetamol and its Process Impurities
5 Nov 2018This application note describes a gradient method using a sub-2 µm column for the simultaneous determination of nine process-related impurities and one degradation product of paracetamol in less than 2 minutes. The high speed and reliability of the method make it well-suited for routine analysis in drug-manufacturing quality control.
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RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Process MonitoringQuality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. ManufacturingManufacturing is the production of merchandise for use or sale using labor and machines, tools, chemical and biological processing, or formulation.