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Register Now for our Free Webinar: Analysis of Elemental Impurities in Pharmaceuticals
07:00 PDT / 10:00 EDT / 15:00 BST / 16:00 CEST, July 15th 2015
13 Jul 2015
Lois Manton-O'Byrne, PhD
Executive Editor
Expert insights
Elemental impurities analysis is of great importance within the pharmaceutical realm due to impurities’ potential impact on quality, safety and efficacy. These impurities can include catalysts and environmental contaminants that may be present in drug substances, excipients or drug product.
During this webinar, an alternative approach for the control of elemental impurities, using microwave/UPLC/UV-VIS will be discussed. This is a powerful, advantageous and fast solution for heavy metals determination, with improvements over traditional methods in terms of time and cost savings.
António Ramos, Analytical Development Group Leader, Hovione; and Lúcia Sousa, PhD Student/Analytical Chemist, Hovione, will discuss the following key points:
- Why elemental impurities need to be controlled throughout the chemical process
- What needs to be tested during the method development process
- What you should consider in your experimental design: qualitative factors vs quantitative factors
- How to minimize time and costs associated with elemental impurity analysis
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UHPLC and HPLCHigh performance liquid chromatography (HPLC) and ultra high performance liquid chromatography (UHPLC), also known as UPLC, are analytical techniques used to separate, identify and quantitate components of complex mixtures including biological samples such as proteins and lipids as well as chemical mixtures of pesticides, drugs and oils. Both techniques are liquid chromatographic methods but differ by operating pressures (HPLC < 6000 psi < UHPLC ). Components of HPLC and UHPLC systems include columns, detectors, pumps, autosamplers and column heaters. Explore a range of UHPLC and HPLC columns for your specific sample needs including reverse phase, normal phase, ion exchange, HILIC, ion exclusion and size exclusion columns. For more specialized HPLC, explore FPLC, countercurrent LC and simulated moving bed systems. Find the best UHPLC and HPLC equipment in our peer reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.UV-Visible SpectroscopyUltraviolet-visible (UV-Vis) spectrophotometers are used to measure the interaction of UV and visible light with a sample, including transmission, reflectance & absorbance. The two major instrument classes are single-beam or double-beam spectrophotometers. More specialized equipment includes colorimeters, spectroradiometers and refractometers. Portable and microvolume spectrophotometers are also available. For the modular spectroscopy lab, explore a range of light sources for combination with a spectrograph/spectrometer and optics. Find the best UV-Vis spectroscopy products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Environmental Monitoring and TestingEnvironmental monitoring and testing uses handheld portable analyzers, kits, spectrometers or chromatography systems for air, water, soil, food and other sample testing. Useful features of analyzers such as BOD and COD include portability, easy calibration, automation and sensitivity. Environmental test kits for pH, water, moisture, etc, should be accurate, sensitive, reliable, fast and easy to use.Elemental AnalysisElemental analysis involves determining the elemental composition of a sample, often used in environmental, pharmaceutical, and material sciences. Techniques like ICP-MS, X-ray fluorescence, and atomic absorption spectroscopy allow precise quantification of elements such as metals and nonmetals in complex matrices. Browse our peer-reviewed product directory to find the best elemental analysis tools, compare products, check reviews, and get pricing directly from manufacturers.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.UV-Visible-NIRUV-Visible-NIR spectroscopy is used to analyze a wide range of samples based on their absorption of ultraviolet, visible, and near-infrared light. It is commonly applied in chemical analysis, material science, and quality control. Browse our peer-reviewed product directory to find the best UV-Visible-NIR spectroscopy systems, compare products, check reviews, and get pricing directly from manufacturers.Environmental ContaminationContaminants in the environment are harmful chemicals that are present in the air, land and water. These include pesticides, pharmaceuticals, persistent organic pollutants (POPs) and many more.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.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.