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.
对于卓越性能和灵敏度有所要求的应用，我们的LC 300 UHPLC系统是其首要选择。LC 300 UHPLC系统具有在高达18000 psi/1240 bar压力下的超精密梯度性能，即使对于要求最为严苛的应用，也能提供其所需的性能和更高的通量。
LC 300 UHPLC平台的主要特性包括：
下一代LC 300 HPLC系统可为常规液相色谱应用提供所需的准确性和灵活性。 LC 300 HPLC凭借其稳定的功能组件和直观的操作，即使面临预算和人员配备方面的挑战，也可让实验室提高生产力和生产能力。
LC 300 UHPLC平台的主要特性包括：
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.
