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Detection of eight nitrosamine impurities from the drug manufacturing process
24 Mar 2021In this application note, discover a highly sensitive, triple quadrupole-based, liquid chromatography/tandem mass spectrometry (LC/MS/MS) method for the simultaneous determination of eight nitrosamine impurities in metformin drug substance and drug products.
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6470B Triple quadrupole LC/MS
Agilent TechnologiesThe Agilent 6470B triple quadrupole LC/MS system delivers robust performance and high versatility for commercial, life sciences research, and regulatory applications.
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ADME-ToxicologyADME-toxicology (ADME-Tox) studies are used in pharmacology and pharmacokinetics to assess the activity/toxicity of drugs <i>in vivo</i> or <i>in vitro</i>. Find bioassays for absorption, distribution, metabolism, and excretion of drug molecules including cytotoxicity, transporter/permeability, metabolism and activity assays as well as hepatocytes and cell lines for ADME. Find the best ADME-toxicology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.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. GenotoxicityDrug TestingIt is essential to test the efficacy and toxicity of drugs at every stage of their development to ensure that a pharmaceutical product is fit for purpose and safe for use before reaching the stage of mass production and distribution.ToxicityToxicity is defined as the degree to which a substance can harm humans or animals. It is essential to study the toxicity of pharmaceutical products during the development process so that optimum dosage can be established for the administration of the drug.Drug DevelopmentDrug development refers to the process of bringing a new drug to market.