3
Figure 3. Reproducibility of the fl ow rate profi le in comparison to the UV Absorbance. Conclusion
This experimental study demonstrates the ability of modern non-invasive fl owmeters to be valuable tools for validating and monitoring gradient in HPLC systems in a way which was impossible until now. By accurately monitoring apparent fl ow rates in real- time and enabling data logging, these fl owmeters ensure that programmed gradient is faithfully reproduced, facilitating precise and consistent separation in HPLC. This enables the use of gradient HPLC with a higher degree of confi dence.
Testa Analytical LC Flowmeters are the perfect tool for labs where higher confidence in HPLC results is desired or necessary. The flexibility and advantages of these non-invasive flowmeters as monitoring device for eluent composition in gradient HPLC systems, has been confirmed in comparison to the traditional UV detection techniques.
Reference 1 See
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www.labmate-online.com Robust bioinert columns for a new level of recovery
Ion exchange chromatography (IEX) is widely used for Bio QC methods, especially for charged variant analyses. Sensitive substances like oligonucleotides tend to interact with column hardware, even with quite inert IEX standard hardware made of PEEK. Adsorption of the analytes on the surfaces lead to peak tailing, carryover, and reduced recovery.
YMC meets this special challenge with the recently launched YMC Accura columns. They feature a bioinert surface coating of the column body and frits. The robust bioinert coating used on YMC Accura hardware is 130 to 320-fold thicker compared to similar hardware concepts. Permanent inertness against sensitive substances is ensured. Therefore, YMC Accura columns can even be used for the analysis of sensitive substances without pre-conditioning.
The non-porous hydrophilic polymer beads of the BioPro IEX stationary phases enable exceptionally high efficiencies and high throughput
analyses. Even small sample variations can be easily separated and detected. The superior lot-to-lot reproducibility guarantees highly reliable results. BioPro IEX SF with its strong cation exchanger functionality is particularly ideal for analysing charge variants of monoclonal antibodies (mAbs) or other proteins. The strong anion exchanger BioPro IEX QF is the first choice for high-resolution analysis of oligonucleotides of different lengths as well as mAbs with lower pI.
The combination of the bioinert coated column hardware and the high efficiency stationary phases of YMC Accura BioPro IEX columns provide excellent peak shapes for sensitive compounds. They ensure high recovery from the very first injection and prevent carry-over. YMC Accura BioPro IEX columns are not only very inert, but are also available with smaller column IDs, making them ideal for use in native IEX-MS analysis.
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ilmt.co/PL/34j1 62489pr@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 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 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 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.
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