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.
If your lab performs many routine impurities testing analyses, you need a flexible, rugged GC instrument that can meet your testing requirements. Our 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.
The TurboMatrix HS-40 Trap features built-in analyte-trapping technology that provides a potential 100-fold increase in sensitivity. Thanks to pressure-balanced technology, TurboMatrix Headspace samplers deliver exceptional performance in the analysis of your samples. Greater sensitivity can be achieved because the system offers an array of unique features and benefits:
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.