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:
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：
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.