Results 11 to 20 of about 329 (162)

Characterisation of Antisense Oligonucleotides by Ion-Pair Reversed-Phase UHPLC-HRMS: Method development using Design of Experiments. [PDF]

J Mass Spectrom
ABSTRACT The quality control of therapeutic antisense oligonucleotides (ASOs) poses significant analytical challenges due to the complexity of their synthesis and degradation processes and the need to ensure the safety and efficacy of active pharmaceutical ingredients (APIs).
Triolo A, Tavani F, Barnini P, Furlanetto S, Orlandini S.   +4 more
europepmc   +2 more sources

AQbD-driven development of a green RP-HPLC method for nirogacestat with LC–MS structural elucidation [PDF]

BMC Chemistry
Nirogacestat (NGT), a recently approved γ-secretase inhibitor for desmoid tumors, requires sensitive and sustainable analytical methods for impurity profiling.
Jayanthi Sabi, Kanaka Parvathi Kannaiah, Hemanth Kumar Chanduluru, Srinivas Nakka, Samar H. Elagamy, Reem H. Obaydo   +5 more
doaj   +2 more sources

Integrating green analytical chemistry and analytical quality by design: an innovative approach for RP-UPLC method development of ensifentrine in bulk and inhalation formulations [PDF]

BMC Chemistry
Background Chronic obstructive pulmonary disease (COPD) is a significant global health issue, worsened by pollution and modernisation. Ensifentrine (EFT), a new dual inhibitor of phosphodiesterase PDE3 and PDE4, is being developed for inhalation to ...
Mohan Goud Vanga, Sarad Pawar Naik Bukke, Praveen Kumar Kusuma, Bayapa Reddy Narapureddy, Chandrashekar Thalluri   +4 more
doaj   +2 more sources

AQbD-Based UPLC-ELSD Method for Quantifying Medium Chain Triglycerides in Labrafac™ WL 1349 for Nanoemulsion Applications [PDF]

Molecules
In response to recent regulatory guidelines, including ICH (International Council for Harmonisation) Q2 (R2) and Q14, we developed a UPLC-ELSD method to quantify Medium-Chain Triglycerides (MCTs) in Labrafac™ WL 1349 for nanoemulsion applications.
Alessio Gaggero, Viktoria Marko, Dalibor Jeremic, Carolin Tetyczka, Philippe Caisse, Jesús Alberto Afonso Urich   +5 more
doaj   +2 more sources

New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis Methods [PDF]

Molecules, 2022
Capillary electrophoresis (CE) is a potent method for analyzing chiral substances and is commonly used in the enantioseparation and chiral purity control of pharmaceuticals from different matrices.
Serena Orlandini, Gabriel Hancu, Zoltán-István Szabó, Adriana Modroiu, Lajos-Attila Papp, Roberto Gotti, Sandra Furlanetto   +6 more
doaj   +2 more sources

Green RP-UPLC Method for Simultaneous Determination of Cyclopentolate and Organic Impurities Using DoE and Sustainability Metrics. [PDF]

Int J Anal Chem
A 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, Alluhayb AH, Al-Khateeb LA, Saleh SM, Binsaleh AY, Mohamed MA.   +5 more
europepmc   +2 more sources

Green UHPLC approach for the quantitative determination of tiopronin residues in cleaning validation processes [PDF]

BMC Chemistry
This study presents the development and validation of a novel reverse-phase ultra-high-performance liquid chromatography (UHPLC) method for quantifying tiopronin residues on manufacturing equipment surfaces as part of cleaning validation.
Jagdish Gohel, Ajay Patel, Rajendra Kotadiya   +2 more
doaj   +2 more sources

Development and validation of a novel isocratic RP-HPLC method using AQbD approach for the quantification of favipiravir [PDF]

European Journal of Pharmaceutical Sciences
In this study, the analytical quality by design (AQbD) approach was used to develop an eco-friendly reversed-phase high-performance liquid chromatography (RP-HPLC) method to identify and quantify favipiravir (FAV).A risk assessment identified factors significantly impacting method performance. Three high level risk factors (X1: ratio of solvent, X2: pH
Balázs Volk, Ildikó Csóka, Gabor Katona   +2 more
exaly   +3 more sources

Standardized neutralization antibody analytical procedure for clinical samples based on the AQbD concept. [PDF]

Signal Transduct Target Ther, 2023
Liu J, Bai Y, Liu M, Tan D, Li J, Wang Z, Liang Z, Xu M, Wang J, Mao Q.   +9 more
europepmc   +4 more sources

PDA-CAD method for the determination of magnesium, pyridoxine and thiamine in a dietary supplement supported by analytical quality by design methodology [PDF]

Arhiv za farmaciju, 2021
In this research, Analytical Quality by Design (AQbD) methodology was used to develop the HILIC-PDA-CAD method for the determination of magnesium, pyridoxine and thiamine content in a dietary supplement. Experiments were conducted on the Dionex Ulitimate
Rmandić Milena, Rađenović Miloš, Stanković Jovana, Protić Ana, Otašević Biljana, Malenović Anđelija   +5 more
doaj   +1 more source