The quality of excipients is extremely important since 90% of medicines are made up of them. When it comes to regulatory guidelines, there are several the industry must follow to cover the Active Pharmaceutical Ingredient testing. For excipients, the most frequently used guideline is the International Pharmaceutical Excipient Council (IPEC). Excipients are well known to improve solubility and absorption, enhance disintegration, and increase stability for biologics/parenteral formulations (including injectables).
Any substance used in a pharmaceutical drug product requires manufacturing under appropriate Good Manufacturing Practices (GMP) and supplied under Good Distribution Practices (GDP). The exact definition of GMP or GDP will depend on the material in question (e.g. excipient, active pharmaceutical ingredient, and packaging) and legislation where the excipient is supplied or sold.
When you control every step of the excipient manufacturing process, you’re ensuring the excipient consistently meets required GMP compliance. The suitability of excipients for its intended use is defined by attributes such as identity, strength, and purity – which can be achieved with our instruments, consumables, and services.
The Spectrum Two™ FT-IR spectrometer delivers everything required to perform FT-IR analyses within regulated environments with complete confidence in the results. From rapid raw material identification to sensitive analysis of formulated products, Spectrum Two offers the best user experience without any compromise in analytical performance. With fully integrated, robust universal sampling for trouble-free measurements and portability options, Spectrum Two is ideal for use in both laboratory and remote testing environments.
The Spectrum Two N™ is a high-performance, yet robust and transportable FT-NIR system platform enabling simple, reliable NIR analyses. It’s the perfect system for labs that need to combine high-end performance with the ease-of-use features of a portable instrument, allowing users with different levels of expertise, from novice to seasoned professionals, to be proficient with it in no time.
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.
The LAMBDA™ 365 delivers state-of-the-art UV/Vis performance that meets the needs of analytical chemists working in CMC testing in drug development and QA/QC manufacturing 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.
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.
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.
The 21 CFR Part 11 compliant Spectrum ES software suite is designed for regulated industries that demand secure IR quality testing. The Spectrum 10 ES suite encompasses the comprehensive features of Spectrum 10™ and encompasses user access control, audit trailing, data security, and data integrity to ensure secure analyses. The software package includes instrument control, basic and advanced data manipulation routines, a spectral calculator, COMPARE spectral comparison, PLS/PCR/Beer’s Law predictions, Report Builder, Report Viewer, and Administration Utility.
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 PerkinElmer PYRIS Enhanced Security option is fully compatible with thermal analysis instruments running on the PYRIS software platform.