Vials have more of an impact on biomolecule analysis than you would think, and thus selecting the right vial for your application is important. Oligonucleotides, proteins, and peptides typically stick to the glass of regular vials, which can cause challenges with method robustness and recovery.
May 24, 2018 · An appropriate control strategy may comprise one or more elements of raw material, in-process and manufacturing controls. Additionally, understanding the role, if any, polysorbates play during stability will require knowledge of the criticality of the excipient, based upon its impact on CQAs due to variations in concentration and degradation level.
VanGuard Pre-Columns are uniquely designed to protect and prolong ACQUITY UPLC column performance while contributing minimal chromatographic effects. `. Discover Waters Chromatography Column Particle Technologies, including Ethylene-Bridged Hybrid (BEH), Charged-Surface Hybrid (CSH), and High-Strength Silica (HSS) column options.
Mar 22, 2023 · The use of chromatography vials in food analysis is critical in ensuring the quality and safety of food products. They prevent contamination and ensure accurate and reliable results. High-quality
The analyses of drugs and metabolites in biological fluids, particularly plasma, serum or urine is one of the most demanding but one of the most common uses of high performance of liquid chromatography. Blood, plasma or serum contains numerous endogenous compounds often present in concentrations much greater than those of analyte.
Nov 25, 2015 · 1 What Validation Is? The purpose of any analytical method is to provide consistent, reliable, and accurate data. For this reason, the performances and the limitations of the method, as well as the external influences which may modify these features, must be determined prior to its use. Validation plays a major role in achieving this goal [ 1, 2].
Typical method-related risks associated with vial quality include adsorption of analyte, appearances of unexpected or “ghost” peaks, ionic effects such as ion suppression or pH changes, mechanical effects (e.g., septa blocking the autosampler needle), and evaporation and chemical incompatibility caused by interactions between the septa/caps and
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Jan 1, 2022 · Traditional ion exchange (AEX or CEX) chromatography, which uses packed bed resin, relies on an understanding of the pI of the target protein as well as impurities. Ion exchange chromatography can be performed in either B/E or FT mode, depending on the net-charge of the target product, which in turn is influenced by the selected buffers.
Nov 1, 2021 · Toxicology-Based Risk Assessments. Toxicology-based risk assessments were conducted based on the extractable profiles of the rubber-stoppered glass vials for the purpose of extractable compounds evaluation, selection, qualification, and finally determining the targeted compounds of toxicological concern as well as the concentration limits for leachables testing of the drug products.
Aug 30, 2021 · In conclusion, this method is sensitive and reliable to compare the quality variance of commercial P188 and is suitable for routine quality control purposes. The application of this method could help in further understanding the Critical Material Attributes (CMA) that may affect the quality attributes of proteins in formulations.
Practically, it is easily done. Start with the smallest volume that your injector can reproducibly inject and keep doubling it until a max 3% of your column’s volume is reached. Then calculate the limit of detection and resolution dependence on injection volume. Be prepared for the need to accept a compromise between detection limit and
Apr 11, 2021 · Timely investment in the development and implementation of continuous biomanufacturing can increase the production of consistent-quality drugs at a lower cost and a faster pace, to meet growing demand. Efficient use of equipment, manufacturing footprint, and labor also offer the potential to improve drug accessibility.
In 2004, separation science was revolutionized with the introduction of Ultra-Performance Liquid Chromatography [UPLC Technology]. Significant advances in instrumentation and column technology were made to achieve dramatic increases in resolution, speed and sensitivity in liquid chromatography. For the first time, a holistic approach involving
weldment can become contaminated from either poor quality gas or graphite/dirty samples. As the temperature in the oven increases, the makeup gas supply tube in the GC oven heats up and condensed material can be liberated into the detector. Normally makeup gas contamination shows up as a broad hump on the baseline.
Aug 20, 2020 · Chromatographic analytical results can be affected by various factors associated with the chromatographic system. Requirements for system suitability testing (SST) are introduced to minimize the risk of such factors having a critical influence on the results. This review covers the chromatographic parameters for SST and their recommended values and categorizes them into five groups depending