3
to offer early identifi cation of an underlying problem like a sticking check-valve or a bearing with a micro-leakage. Adding pre-emptive service measures will lead to less equipment downtime and higher HPLC/uHPLC user satisfaction.
Looking to the future, permanently connecting a non-invasive fl owmeter to an HPLC/ uHLPC system, and storing real-time fl ow data along with chromatographic data, offers the potential for a fi eld service engineer to access the full history of pump performance since the last validation.
In conclusion, Field Service Engineers are vital for assuring the quality of performance of all HPLC/uHPLC systems. The best available tool for HPLC / uHPLC pump validation, fl ow measurement and fl uidic troubleshooting today is undoubtedly a non-invasive real- time liquid fl owmeter. For further information please visit:
https://www.testa-analytical.com/
hplc-chromatography.html
The author: Carlo Dessy is Managing Director of Testa Analytical Solutions eK, a respected international developer and supplier of instruments, innovative detectors and software for chromatography applications and molecular weight determination. He may be contacted on
cdessy@testa-analytical.com
Read, Share and Comment on this Article, visit:
www.labmate-online.com Figure 3: Saving HPLC fl ow and chromatographic data in real time
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 specifi c 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 identifi cation and quantifi cation of these contaminants are vital, as demonstrated by the NDMA fi ndings 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 quantifi cation of the nitrosamines present.
To prepare pharmaceutical samples for analysis, a process involving methanol extraction, centrifugation, and fi ltration is employed. This preparation is essential for obtaining accurate and reliable results. Notably, the TEA by Ellutia is recognised for its sensitivity and specifi city, which signifi cantly 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 effi cacy.
More information online:
ilmt.co/PL/1ANm 62525pr@reply-direct.com New HPLC system enhances biopharma QC effi ciency
Waters has introduced the Alliance iS Bio HPLC System, a revolutionary solution tailored to address the unique operational and analytical hurdles encountered by biopharma quality control (QC) labs. Engineered to optimise effi ciency, ensure compliance, and accelerate product delivery, this system is poised to meet the stringent requirements of the biopharma industry.
With a focus on enhancing productivity, the Alliance iS Bio HPLC System targets common errors, aiming to eliminate up to 40% of these occurrences. By minimising the time spent on investigating failed runs and out-of-specifi cation results, QC analysts can streamline their workfl ow and expedite sample analysis.
Featuring a bio-inert design in critical internal components, including the system fl ow path, this innovative solution mitigates unwanted interactions from metal- adsorbing analytes. This safeguard ensures the integrity of the analysis, providing reliable and accurate results.
The system offers the fl exibility to leverage platform methods with confi dence, reducing the need for extensive column conditioning and method development. This capability not only saves time but also enhances the effi ciency of the QC process.
Complementing the Alliance iS Bio HPLC System is the integration with Waters Empower Chromatography Software. This seamless collaboration facilitates data collection, management, and reporting of chromatography test results. Compatible with both Waters and third-party liquid chromatography instruments, this integration empowers high-volume QC labs to effi ciently manage operational risks, overcome disruptions, and optimise overall productivity.
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ilmt.co/PL/7nv1 62639pr@reply-direct.com
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is a next generation refractive index detector purpose built for modern HPLC analysis. offers unmatched baseline stability. Unlike traditional RI detectors that may take up to 1 hour to be fully stable – the is ready to deliver reliable, reproducible results in just a couple of minutes from turning on. Its sensitivity makes it the perfect RI detector to integrate with any modern HPLC system
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