Results 11 to 20 of about 529 (166)
Quality by design‐guided development of a capillary electrophoresis method for the simultaneous chiral purity determination and impurity profiling of tamsulosin [PDF]
Journal of Separation Science, Volume 46, Issue 24, December 2023., 2023 Analytical Quality by Design principles using the design of experiments were applied for the development of a capillary electrophoresis method for the determination of enantiomeric purity and chemically related impurities of tamsulosin.
Hancu, Gabriel +3 more
core +2 more sources
A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development. [PDF]
ElectrophoresisABSTRACT The ICH Q14 guideline introduces a structured framework for analytical method development based on Analytical Quality by Design (AQbD) principles, aiming to ensure robust, reliable, and fit‐for‐purpose methods throughout the product lifecycle.
Tricht EV, Sänger-van de Griend CE.
europepmc +2 more sources
Green RP-UPLC Method for Simultaneous Determination of Cyclopentolate and Organic Impurities Using DoE and Sustainability Metrics. [PDF]
Int J Anal ChemA significant improvement in sustainability and efficiency is achievable through green and white chemistry. As part of this study, sustainability assessment tools were used to assess the environmental impact and practicality of an innovative, straightforward RP‐UPLC method to analyze cyclopentolate (CLO) and its organic impurities simultaneously in ...
Alsehli BR +5 more
europepmc +2 more sources
ELECTROPHORESIS, Volume 44, Issue 17-18, Page 1279-1341, September 2023., 2023 Abstract This review is in support of the development of selective, precise, fast, and validated capillary electrophoresis (CE) methods. It follows up a similar article from 1998, Wätzig H, Degenhardt M, Kunkel A. “Strategies for capillary electrophoresis: method development and validation for pharmaceutical and biological applications,” pointing out ...
Finja Krebs +11 more
wiley +1 more source
Journal of Chemical Technology &Biotechnology, Volume 97, Issue 9, Page 2347-2364, September 2022., 2022 Abstract The transition to continuous biomanufacturing is considered the next step to reduce costs and improve process robustness in the biopharmaceutical industry, while also improving productivity and product quality. The platform production process for monoclonal antibodies (mAbs) is eligible for continuous processing to lower manufacturing costs ...
Mariana N São Pedro +3 more
wiley +1 more source
Sixteen capillary electrophoresis applications for viral vaccine analysis
ELECTROPHORESIS, Volume 43, Issue 9-10, Page 1068-1090, May 2022., 2022 Abstract A broad range of CE applications from our organization is reviewed to give a flavor of the use of CE within the field of vaccine analyses. Applicability of CE for viral vaccine characterization, and release and stability testing of seasonal influenza virosomal vaccines, universal subunit influenza vaccines, Sabin inactivated polio vaccines ...
Lars Geurink +6 more
wiley +1 more source
International Journal of Analytical Chemistry, Volume 2022, Issue 1, 2022., 2022 Quality‐by‐design (QbD) is defined as a systematic approach to design and develop a product/service based on sound science and quality risk management. It is already frequently applied in the pharmaceutical industry mainly in the development of pharmaceutical products and analytical methods but is not well established in the setup of facilities like ...
Sultan Suleman +9 more
wiley +1 more source
Analytical Science Advances, Volume 2, Issue 1-2, Page 2-14, February 2021., 2021 Abstract The aim of this work was to develop a supercritical fluid chromatographic method to study the applicability of this emerging technique to cannabinoid analysis and showcase its advantages. During method development, the authors focused on nine phyto‐cannabinoids to assess the selectivity needed to potentially perform the quantitation of each ...
Riccardo Deidda +7 more
wiley +1 more source
ELECTROPHORESIS, Volume 42, Issue 1-2, Page 10-18, January 2021., 2021 Abstract Vaccines against infectious diseases are urgently needed. Therefore, modern analytical method development should be as efficient as possible to speed up vaccine development. The objectives of the study were to identify critical method parameters (CMPs) and to establish a set of steps to efficiently develop and validate a CE‐SDS method for ...
Lars Geurink +4 more
wiley +1 more source
Method operable design region obtained with a partial least squares model inversion in the determination of ten polycyclic aromatic hydrocarbons by liquid chromatography with fluorescence detection [PDF]
, 2021 A chromatographic method with the Analytical Quality by Design (AQbD) methodology is developed for the simultaneous determination by HPLC-FLD of ten PAHs (naphthalene, phenanthrene, anthracene, flu- oranthene, pyrene, chrysene, benzo[a]anthracene ...
Arce Antón, Mar +5 more
core +1 more source