Residual Solvents
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.
Clarus Nova GC System
Designed to address the needs for remote control, simplified and sustainable operations of analytical laboratories, the PerkinElmer Clarus® Nova GC 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.
HS 2400™ Headspace Autosampler
Precise, automated headspace analysis for reliable detection of volatile compounds with high precision, accuracy and minimal carryover, supporting product quality and regulatory compliance. Designed for routine pharmaceutical workflows, it simplifies operation while maintaining consistent performance.
- Pressure-balanced sampling for consistent, reproducible results
- Low carryover design to maintain data integrity across sensitive analyses with accuracy
- Automated, high-throughput workflows with gas-saving and low-maintenance operation
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.
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.
Software
SimplicityChrom CDS Software, a modern, intuitive and flexible CDS software platform that enables you to efficiently control the instrument, process data, and generate results. Pair this functionality with the peace of mind of 21 CFR Part 11 compliance and industry-leading service and support, and you're free to focus on what matters most - your analytical goals.
Featured Resources
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GC-FID: Determination of Diethylene Glycol and Ethylene Glycol according to USP Propylene Glycol Monograph
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