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Residual Solvents

The synthesis of active pharmaceutical ingredients (API) may require multiple reaction steps that produce undesirable reaction byproducts or utilize various solvents that must be removed from the finished product. These solvents and byproducts may be measured with headspace gas chromatography for those volatile residual organic solvents according to the USP chapter <467> method and ICH Q3C guidelines.

Residual solvents in drug substances, excipients, and in drug products should be tested using analytical techniques to ensure levels of residual solvents are meeting criteria established by ICH Q3C guidelines. Any harmonised procedures for determining levels of residual solvents as described in the pharmacopoeias should be used, if feasible. Otherwise, manufacturers would be free to select the most appropriate validated analytical procedure for an application.

We provide the tools you need for you to take control of residual solvents testing.

GC 2400 system

GC 2400 System

Designed to address the needs for remote control, simplified and sustainable operations of analytical laboratories, the 爱游戏平台注册登录 GC 2400™ System provides an innovative user experience with information on the go for effective and faster decision-making and advanced system capabilities for maximized productivity, thanks to reduced technology adoption costs and features supporting sustainability.

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HS 2400 M Headspace Autosampler

By being completely integrated into the GC workflow, the HS 2400 M Headspace Sampler communicates directly with the 爱游戏平台注册登录 GC 2400™ GC System. The integrated technology allows users to access live status information from the headspace sampler directly on the GC detachable touchscreen, in and outside the lab.

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Clarus GC

Consumables

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.

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OneSource IQ/OQ Services

Services

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.

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