Inspections of drug substances are designed to confirm manufacturing plants, as well as the quality control laboratory, follow CGMP regulations.
An extensive set of analytical testing and acceptance criteria are applicable to drug substances including universal and specific test criteria established by ICH Q6 guidelines and methods described in the specific monograph for the raw API. All drug substances should undergo a specific, stability-indicating assay to determine their strength and content.
All drug products must be GMP compliant before release for commercial use. We provide the tools you need to release safe and effective medicines, giving you peace of mind when it comes to audits.
The PerkinElmer Spectrum 3™ range of near, mid, and far infared fourier transform (FT-IR) spectrometers provide the ultimate sampling flexibility and spectroscopic performance you need. The highly configurable platform provides dependable, consistent and trouble-free operation through years of service. Spectrum 3 is loaded with a range of advanced innovations designed to provide you with exceptional performance and flexibility from the configuration you choose.
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 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, the Spectrum Two system offers the best user experience without any compromise in analytical performance. With fully integrated, robust universal sampling for trouble-free measurements and portability options, this system is ideal for use in both laboratory and remote testing environments.
The Spectrum Two N™ is a high-performance, 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 in no time.
Spectrum Two N FT-NIR spectrometers feature:
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.
Keep your scientists focused on science and away from activities keeping them from discovering the next breakthrough. Whether you need trained scientists, assistance analyzing the results from an FDA finding to determine corrective actions and roll them out, or trained IT resources to upgrade you to the latest version of software across your entire enterprise, OneSource has the trained, certified experts that will support your lab operations.
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.
The 21 CFR Part 11 technically 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.
