Pharmaceutical laboratories must evaluate the interactions between packaging material and formulation, applying risk assessments defined on ICH Q9 guidelines to guarantee the safety and quality of finished dosage forms being released to the market.
Studies about extractables and leachables are critical for maintaining the quality of your drug product during drug development and final batch release in accordance with GMP compliance. The testing process assesses whether the drug products could be exposed to any harmful leachable contaminants that could have a detrimental impact upon the safety and efficacy of the drug.
In general, extractables and leachables can be divided into three broad groups:
Elemental Impurities in extractables and leachables are best determined by ICP-OES, ICP-MS, and GC-MS for volatiles whereas HPLC or UHPLC are preferable method for non-volatile compounds. We provide the tools you need to take control of your extractables and leachables testing.
Patented ion optic design (triple cone interface and quadrupole ion deflector) delivers no maintenance of the components within the vacuum region, maximizing sample throughput and lowering operating costs.
Patented Flat Plate™ plasma technology utilizes maintenance-free induction plates and uses half the argon of helical coil systems, dramatically reducing operating costs.
Transversely heated graphite atomizer (THGA) and longitudinal Zeeman background correction provide superior sensitivity for complex matrices.
Top-loading system with an interlocked lid allows easy loading and removal of individual vessels.
The Clarus® SQ 8 GC/MS offers unsurpassed sensitivity and unparalleled stability for identification and quantitation of volatile and semi-volatile compounds (VOC and SVOC). It's designed to deliver high throughput, rugged dependability, and great results. Plus, with our patented SMARTsource™ (for both EI and CI), maintenance is easy.
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:
Ultra-high performance means the highest resolution, highest sensitivity and fastest analysis for your stability-indicating assays. 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, our Flexar LC is easy to use and simplifies your day-to-day processes so you can focus on your applications.
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.
Our Syngistix™ atomic spectroscopy software platform, the industry’s first cross-platform instrument control solution, allows lab professionals to work seamlessly across multiple techniques, enhancing laboratory productivity. Plus, its unique icon-based design simplifies navigation and walks you through every step of the analysis — from setting up to acquiring data to reporting results. Now an Enhanced Security™ version is available that meets the special needs of highly regulated labs that must comply with the U.S. FDA’s 21 CFR Part 11 regulations and EU GMP Annex 11 compliance.