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Implementation of USP New Chapters <232> and <233> on Elemental Impurities in Pharmaceutical Products

PerkinElmer
4 Nov 2013

This whitepaper is intended to keep the pharmaceutical community abreast of the latest developments with regard to the new chapters on elemental impurities in pharmaceutical products in the United States Pharmacopeia’s (USP) National Formulary (NF). It provides an overview of the salient points described in Chapter <232> on Elemental Limits and Chapter <233> on Analytical Procedures and offered suggestions as how best to approach the determination of elemental impurities in pharmaceutical products using PerkinElmer ICPAES/ OES and ICP-MS instrumentation. It is meant to be the first step in educating pharmaceutical laboratories and explaining why the old “Heavy Metals Test”, described in Chapter <231> is being replaced with these two brand new chapters. The approval of Chapter <2232> –“Elemental Contamination of Dietary Supplements” – is still going through the USP review and comments process.

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NexION 350 ICP-MS Spectrometers

PerkinElmer

When your instrument is more efficient and productive, so too are your scientists and your lab. And nothing puts the flow in your workflow better than the NexION® 350 ICP-MS. With a data acquisition speed 10 times faster than any other ICP-MS on the market, the new NexION 350 ICP-MS opens up a whole new world of efficiency and opportunity, allowing you to measure more in less time, and accurately characterize nanoparticles. In addition to the exceptional application flexibility afforded by its speed, the instrument also delivers superior uptime and productivity through a variety of unique features engineered to enhance signal stability: Triple Cone Interface produces the industry’s most tightly focused ion beam and prevents sample deposition on internal components. Quadrupole Ion Deflector turns positively charged ions 90° into the Universal Cell and filters off neutrals. Analyzing Quadrupole made of a unique steel alloy for negligible thermal expansion for unparalleled stability. No extraction lenses to clean for minimized maintenance.

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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. Sample ManagementSample management systems include sample storage devices such as freezers and plate storers, sample environment enclosures and sample organization, retrieval and sorter systems. Useful system features include high-throughput, automation, robotic arms, automated liquid handling and associated database systems. Accessories in sample management include barcode scanners, heat sealers and tubes.Process ChemistryProcess chemistry is an important stage of drug development for scaling-up drug production or chemical synthesis reactions. It is useful for optimizing economical and efficient drug production. Process chemistry uses reactors and pump systems as well as reagents, standards and buffers.Bioprocessing / FermentationBioprocessing is the use of biological materials to perform commercial, scientific or medical research processes. Biological materials used include cells, enzymes and organisms. Usually bioprocessing requires a batch or continuous bioreactor such as a fermentor or cell culture system. The advantages of using a reactor include high productivity, easy configuration, adjustable values and automation.Drug DevelopmentDrug development refers to the process of bringing a new drug to market.BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.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.Drug DiscoveryDrug discovery is the process of identifying potential new medications, involving stages such as target identification, compound screening, and preclinical development. It relies on cutting-edge technologies like high-throughput screening, artificial intelligence, and molecular modeling to accelerate the identification of drug candidates. Drug discovery plays a pivotal role in developing new therapies for diseases ranging from cancer to rare genetic disorders. Browse our peer-reviewed product directory to find the latest drug discovery technologies, compare options, check customer feedback, and get pricing directly from manufacturers.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.BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.

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