Pharmaceutical Excipient Characterization
15 Dec 2014The first case study presented in this application note showcases the use of Morphologically Directed Raman Spectroscopy (MDRS) for component specific morphological analysis of a blend of lactose and API. The second case study presents the use of laser diffraction bulk material characterization tool which can support excipient particle size measurement requirements from formulation development through to QC analysis.
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Mastersizer 3000
Malvern PanalyticalWorld’s most widely used particle size analyzers, the smartest way to measure particle size. There is a newer version of this product avilable, the Mastersizer 3000+ Ultra.
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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. FormulationFormulation is the process of combining active pharmaceutical ingredients with excipients to produce a drug which is both stable and active.Active PharmaceuticalsThe Active Pharmaceutical Ingredient (API) of a drug is the component that causes the direct effect of the product. The remaining inactive components are known as excipients.Lactose