Content uniformity is an essential quality measure during the production of finished dosage forms and requires the best blend uniformity, which is particularly important for ensuring consistency and uniform API concentration in the final dosage form.
Due to this growing concern, the cGMP in 21CFR 211.110 requires in-process controls to verify the uniformity and integrity of each pharmaceutical batch of the drug product. Near Infrared (NIR) and Raman spectroscopic methods are useful for the online assessment of powder blend homogeneity of APIs and excipients, as these methods can provide homogeneity information on the homogeneity of all mixture components.
There has been an increasing emphasis on quality by design (QbD) and the use of process analytical technology (PAT) to monitor and control pharmaceutical manufacturing processes. FDA encourages the use of new technologies and PAT techniques, such as NIR spectroscopy, for content uniformity analysis.
We have the tools required to guarantee content uniformity on your path to GMP compliance.
Spotlight™ IR microscope systems are designed to meet the challenges of pharmaceutical industry by generating high-quality, reproducible data from a variety of sample types. The Spotlight 400 FT-IR imaging system combines high sensitivity and rapid imaging with ease-of-use. The ability to image large sample areas rapidly at high spatial resolution extends FT-IR microscopy into new applications. The Spotlight 400 FT-IR imaging system is designed with state-of-the-art technology to allow for intelligent automation and sophisticated analysis capabilities.
Unique features of the Spotlight 400 system include:
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:
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 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.