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.
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.
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.
