ResourceSpectroscopy
Nitrosamine impurities application guide
11 Feb 2021Mutagenic impurities in APIs and drug products pose a significant risk to health and safety – even in small quantities – and thus are a major concern for drug manufacturers. In this application guide, Agilent Technologies provides an overview of recent regulatory action regarding nitrosamine impurities and outlines a complete workflow solution for the accurate detection and quantification of mutagenic impurities in APIs and drug products.
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LC-MSLC-MS (liquid chromatography-mass spectrometry) systems and equipment are used for separation and quantitative analysis of complex mixtures, combining liquid chromatography and mass spectrometry. Quantify proteins, contaminants, pesticides or screen for drug metabolites with a high level of sensitivity. LC-MS systems and equipment include reverse phase, normal phase and specialized columns integrated with various MS detectors such as time-of-flight (TOF), quadrupole, orbitrap or ion trap mass analyzers. LC-MS/MS instruments equipped with a qTOF or triple quadrupole analyzer give greater sensitivity and resolving power to your analysis. Find the best LC-MS equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Mass SpectrometryMass spectrometry (MS) is a powerful analytical technique used to identify and quantify molecules based on the mass-to-charge ratio of gas-phase ions. It provides detailed information about the structure, composition, and properties of compounds and is widely used across fields such as environmental monitoring, materials science, drug discovery and development, food and beverage testing, and wider chemical research. Key MS techniques include tandem mass spectrometry (MS/MS), liquid chromatography–mass spectrometry (LS-MS) and inductively coupled plasma (ICP-MS). Choosing from these wide range of techniques and technologies can be a daunting task, so keep up to date with scientific applications, performance expectations, and customer reviews here all in one place. Visit our product directory to receive quotes direct from the manufacturer.
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. Drug 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.Therapeutic Drug ManagementDrug DevelopmentDrug development refers to the process of bringing a new drug to market.
