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Determination of genotoxic nitrosamine impurity in Bumetanide API and tablets

Agilent Technologies
24 Mar 2021

In this application note, discover an LC/MS/MS based method designed to overcome the challenges faced when undertaking quantitative analysis of N-nitroso Bumetanide impurity in Bumetanide API and low dose tablets.

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Agilent 1290 Infinity II LC System

Agilent Technologies

The 1290 Infinity II LC System is an ultra-high performance LC that has market-leading sample capacity and is designed for the lowest dispersion for the most challenging ultra-HPLC experiments. The 1290 Infinity II LC system is designed to be both a HPLC and high-end UHPLC system in a single flow path, giving you robust and excellent performance no matter what application you are running while seamlessly integrating into your existing laboratory environment.

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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.GC-MS GC-MS (gas chromatography-mass spectrometry) instruments and equipment are used to separate, quantify and identify mixtures of small and volatile compounds, such as polycyclic aromatics, fatty acids and alcohols. Often used in drug detection, forensic investigation and environmental analysis for pesticides and contaminants, GC-MS is a powerful addition to your lab’s analytical capabilities. GC-MS/MS instruments equipped with a qTOF or triple quadrupole analyzers can give greater sensitivity and resolution to your analysis. Find the best GC-MS instruments and equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. 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.Trace Level ImpuritiesTrace level impurities refer to low concentrations of unwanted substances found in chemicals, pharmaceuticals, and other products. Detecting and removing these impurities is crucial for product safety and regulatory compliance. Explore trace impurity analysis tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.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.

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Determination of genotoxic nitrosamine impurity in Bumetanide API and tablets