Chromatography 7 Intuitive software for multi-detector GPC/SEC
ParSEC Advanced software from Testa Analytical is designed to acquire and analyse data from GPC /SEC systems fitted with any combination of refractive index, light scattering, UV, and viscosity detectors.
Traditionally the complexity of data acquisition, storage, visualisation, analysis, and reporting from multi-detector GPC/SEC systems has limited its effective use to chromatography and macromolecular characterisation specialists.
With all necessary tools and options accessible with a single mouse click - ParSEC sets a new benchmark for ease-of-use and productivity.
ParSEC is fully compatible with all GPC/SEC detectors and systems including those from Testa Analytical. This powerful, yet easy-to-use software package includes many attractive and practical features that have been written for the benefit of even occasional users.
Features include ‘function specific’ views, ensuring the uncluttered display of information relevant to the task at hand, plus customisable display, and annotation options for all graph types. All operating conditions, raw data files, analysis methods, related calibrations, results, and sample information are stored in a database for easy archiving and retrieval.
More information online:
ilmt.co/PL/D5KW 63053pr@reply-direct.com
Detection of speciated volatile nitrosamines in pharmaceuticals using GC-TEA
In the pharmaceutical industry, the safety of medications is a critical concern, particularly with the risk posed by nitrosamine contamination. Nitrosamines, such as N-Nitrosodimethylamine (NDMA), are carcinogenic compounds that may form during drug manufacturing under specific conditions. Addressing this challenge, Ellutia’s 800 series Thermal Energy Analyser (TEA) provides a sophisticated solution for the accurate analysis of volatile nitrosamines through Gas Chromatography coupled with Thermal Energy Analysis (GC-TEA).
Nitrosamines typically arise when an amine - often a secondary amine - reacts with nitrosating agents like nitrites, either under acidic conditions or at elevated temperatures during the manufacturing process. The identification and quantification of these contaminants are vital, as demonstrated by the NDMA findings in Ranitidine, a formerly widespread antacid that was revealed to form NDMA over time under standard storage conditions.
Under EU Regulation (EC) No 726/2004, which establishes acceptable limits for 27 different nitrosamines, pharmaceutical manufacturers are mandated to perform risk assessments and conduct regular testing for these compounds. This regulation ensures that all medications adhere to safety standards prior to reaching consumers.
The operation of the GC-TEA system by Ellutia involves separating nitrosamines within the GC column, followed by their elution into the Pyrolyser. Here, the nitrosamines decompose to release nitric oxide (NO), which is subsequently detected by the TEA after reacting with ozone. This sequence facilitates the precise quantification of the nitrosamines present.
To prepare pharmaceutical samples for analysis, a process involving methanol extraction, centrifugation, and filtration is employed. This preparation is essential for obtaining accurate and reliable results. Notably, the TEA by Ellutia is recognised for its sensitivity and specificity, which significantly reduce background noise and interference - common issues in the detection of nitrosamines.
Incorporating the GC-TEA system into pharmaceutical testing protocols provides a robust mechanism for adhering to safety regulations and safeguarding public health. By offering detailed and reliable methods for analysing volatile nitrosamines, Ellutia reinforces the pharmaceutical industry’s dedication to drug safety and efficacy.
More information online:
ilmt.co/PL/1ANm 62525pr@reply-direct.com
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