, USP <233>, ICH Q3D, Elemental Impurities Testing; Risk Assessment; Permitted Daily Exposure (PDE)">
Elemental Impurities in drug products can arise from several sources, including interactions with processing equipment or container/closure systems, presence in the components of the drug product, or even intentionally through residual catalysts added in synthesis. However they got there, the levels of impurities need to be controlled or they can have a negative impact on your final drug product.
In developing controls for elemental impurities in drug products, the principles of quality risk management, described in ICH Q8 and Q9 guidelines, should be considered. The risk assessment should be based on scientific knowledge and is critical to your success.
The ICH Q3D guideline for finished drug products is divided into three parts:
That means you need the right techniques and tools to help you maintain compliance. From sample preparation and instrumentation to our comprehensive toolkit, we offer complete, integrated solutions to ensure your work fully adheres to the guidelines set out in USP <232>/<233> and ICH Q3D.
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.
With our patented ion optic design (Triple Cone Interface and Quadrupole Ion Deflector), there’s no maintenance of components within the vacuum region, maximizing system uptime and lowering operating costs.
Patented Flat Plate? plasma technology utilizes maintenance-free induction plates and consumes 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.
Our accessories, consumables, methods, and application support meet the most demanding requirements and are the preferred choice in thousands of laboratories globally.
We test and validate 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.