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 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:
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.
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.