Pharmaceutical laboratories summarise actual and potential impurities that are most likely to arise during the synthesis, purification, and storage of the drug substance and excipients. The finished dosage forms summarize the degradation products observed during manufacture and stability studies of the drug product, including impurities arising from the interaction with excipients and/or the immediate container closure system.
All the studies conducted to characterize any impurity at a level greater than the identification threshold – in any batch manufactured by the proposed commercial process – should be identified. In addition, any degradation product observed in stability studies at recommended storage conditions at a level greater than the identification threshold should be identified to guarantee the safety of medicines.
We provide the tools and processes you need to take control of your organic impurities testing for drug substances, drug products, and excipients.
Ultra-high performance means the highest resolution, highest sensitivity and fastest analysis to detect impurities in samples. The Flexar™ FX-20 is the ultimate in UHPLC with maximum throughput and minimum stress for you. Getting more sample information in less time lets you be more productive. Just what you want.
The need for high performance and reliability are a given for QC labs performing assays to determine the strength and content of drug substances. Our proven, rugged, and reliable Flexar™ HPLC system is the perfect choice when you need fast cycle times, reproducibility, and low carryover. With its elegant streamlined interface,the Flexar HPLC is easy to use and simplifies your day-to-day processes so you can focus on your applications.
If your lab performs routine impurities testing analyses, you need a flexible, rugged GC instrument that can meet your testing requirements. The Clarus® 590 gas chromatograph is a fully automated GC system that delivers capabilities that enable high performance, flexibility, and stability. Along with proven strengths of our GC platform, the Clarus 590 GC features a new high-performance capillary injector with decreased reactivity, and autosampler technology that delivers multiple options for liquid injection, headspace, and SPME in one system.
When the highest levels of throughput are critical to your operations, choose the Clarus® 690 gas chromatograph. Its patented high-performance oven delivers the fastest heat-up and cool-down of any oven in the business, and that means shorter injection-to-injection times, and the ability to run more samples per day. Plus, the oven’s twin-wall design with concentric air exhaust provides exceptional cooling to near-ambient temperatures without resorting to liquid cryogen – critical for analysis of organic compounds.
Our accessories, consumables, methods, and application support meet the most demanding requirements and are the preferred choice in thousands of laboratories globally.
We invest heavily in testing and validating our complete portfolio of solutions to ensure that you receive accurate, repeatable results – on-time, every time – throughout the lifetime of your instrument. We also offer a complete portfolio of specialized consumables that deliver reliable performance, control operating costs, and maximize the uptime of your instrument.
The OneSource® UOQ program provides an instrumentation qualification program for maximum productivity and ongoing regulatory compliance capability. The program encompasses pharmacopeial (USP, EP, and JP) compliance with a design and approach that streamlines documentation across all major models of laboratory instruments, regardless of manufacturer.
OneSource Compliance Services ensures the highest levels of compliance with international regulations and guidelines. UOQ enables a seamless, cross-platform approach to a contemporaneous and automated documentation process, letting you gain immediate access to raw data from computer or database, for increased scientific productivity.