Drug manufacturers may be required to accelerate or force degradation of a product to demonstrate that it has gone through the stability indicating method. In some cases, QC labs are be able to find background data for the specificity of a method – either from literature or from the supplier of the drug substance. Then, validation is straightforward with the typical parameters listed in the USP in chapter <1225> on validation of compendial methods.
Degradation product levels can be measured by a variety of techniques, including those that compare an analytical response for a degradation product to that of an appropriate reference standard. Acceptance criteria and analytical procedures are often based on analytical assumptions such as equivalent detector response and should be included in the registration application. Differences between the analytical procedures used during development and those proposed for the commercial product should also be included.
Identification and quantification of degradation products (if below ICH threshold levels) require the use of analytical technologies, consumables, and services to make sure your lab is GMP compliant. We provide the tools you need for you to take control of your degradation products testing.
The LAMBDA™ 365 delivers state-of-the-art UV Vis performance that meets the needs of pharmaceuticals, analytical chemists, geneticists, and manufacturing QA/QC analysts everywhere. With 21 CFR part 11 compliant software available, the LAMBDA system is ready to support everything from standard methods and applications to those requiring regulatory compliance.
The DSC 8500 is a double-furnace DSC, featuring our second-generation HyperDSC® technology. Now you can gain unlimited insight into the structure, properties, and performance of your materials. With hyper-enabled, double-furnace technology and better application capabilities, the DSC 8500 gives you higher accuracy and sensitivity. The HyperDSC heating and cooling with extremely fast controlled scanning rates and in-situ ballistic cooling is important for applications such as isothermal crystallization, polymorph/amorphous-material studies, and high sensitivity measurements.
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.
Unleash the power of your LAMBDA UV/Vis spectrophotometer with UV WinLab software designed for operational simplicity and the power to address the most challenging analyses. Our Enhanced Security™ (ES) UV WinLab software is designed for busy pharmaceutical, manufacturing, industrial, food, or academic laboratories in regulated environments that require compliance with US FDA 21 CFR Part 11 regulations.
PYRIS™ Enhanced Security Software enables 21 CFR Part 11 technical regulatory compliance to help users in both research and quality control to comply with the stringent data security requirements of regulated industries. Key features of the PYRIS Enhanced Security Software include user level management, file protection, audit trails, and electronic signatures. The electronic signature capability is integrated into the software, providing customers with a complete package from a single source. The PerkinElmer PYRIS Enhanced Security option is fully compatible with thermal analysis instruments running on the PYRIS software platform.