Streamlining Analysis of Impurities in Pharmaceutical Products Using Empower 3 ICH Impurity Processing
3 Mar 2015Impurity profiling including identity and quantity in the drug substances or drug products is a requirement with which every manufacturer must comply. This application note demonstrates the use of Empower® 3 ICH Impurity Processing for streamlining the analysis of impurities of Ziprasidone HCl by defining allowable threshold limits and quickly identifying impurities above the ICH allowable limits defined by the user.
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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. PharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.Impurities