During the process of manufacturing finished dosage forms (solids), an organic molecule can adopt more than one crystalline form which can have significant effects on the performance of an active pharmaceutical ingredient (API), for example solubility.
Whichever crystallization method is used to generate solid samples of the API, it is very important to identify which polymorphic form has been produced by using a variety of analytical techniques. Thermal analysis plays a role via differential scanning calorimetry (DSC) and thermal gravimetric analysis (TGA).
The critical issues are control of the polymorphic form of the drug substance and the dissolution behavior of the drug product. We offer a range of thermal analysis solutions improving accuracy, sensitivity, and performance of your analytical testing.
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.
TGA 8000™ gives you complete control over your sample environment while delivering enhanced performance, maximum application flexibility, high throughput and reliability – even unattended. Plus, our advanced hyphenation technology works beautifully with FT-IR, MS, GC/MS, and more for greater understanding of evolved gases.
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.
PYRIS™ Enhanced Security Software enables 21 CFR Part 11 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 爱游戏平台注册登录 PYRIS Enhanced Security option is fully compatible with thermal analysis instruments running on the PYRIS software platform.
