Results 21 to 30 of about 796 (185)

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

Definições e escopo dos elementos-chave do Analytical Quality by Design (AQbD) para o desenvolvimento de métodos na indústria farmacêutica

Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia, 2023
Introdução: O setor farmacêutico está em constante evolução e é altamente regulado com normas para garantir eficácia, segurança e qualidade dos medicamentos.
Rosemberg Bernardez Moure, Flávia Furtado de Mendonça de Sousa, Diogo Dibo do Nascimento, Jorge Lima de Magalhães, Camila Areias de Oliveira, Livia Deris Prado   +5 more
doaj   +1 more source

Perspectives in modeling and model validation during analytical quality by design chromatographic method evaluation: a case study

AAPS Open, 2021
Design of experiments (DOE)-based analytical quality by design (AQbD) method evaluation, development, and validation is gaining momentum and has the potential to create robust chromatographic methods through deeper understanding and control of ...
Yongzhi Dong, Zhimin Liu, Charles Li, Emily Pinter, Alan Potts, Tanya Tadey, William Weiser   +6 more
doaj   +1 more source

Development of a Unified Reversed-Phase HPLC Method for Efficient Determination of EP and USP Process-Related Impurities in Celecoxib Using Analytical Quality by Design Principles

Molecules, 2020
This article presents the development of a reversed-phase (RP) high-performance liquid chromatographic (HPLC) method for determination of process-related impurities in a celecoxib drug substance following Analytical Quality by Design (AQbD) principles ...
Tim Tome, Zdenko Časar, Aleš Obreza
doaj   +1 more source

AQbD-Oriented UHPLC/MS/MS Method Development for Glycopeptides Assessment in Pharmaceutical Forms

Journal of Chromatographic Science, 2021
Abstract Vancomycin and teicoplanin are glycopeptide antibacterials that inhibit the bacteria cell wall synthesis showing activity against gram-positive bacteria. Development of the sensitive method is of great importance for quality control of these drugs that are fermentation products.
A, Stajić, J, Janković-Maksić, B, Jančić-Stojanović, M, Medenica   +3 more
openaire   +2 more sources

Quality by Design‐Based Development of a Robust LC Method for Simultaneous Estimation of Process‐ and Degradation‐Related Impurities in Rifapentine Drug Product for the Treatment of Active and Latent Tuberculosis [PDF]

Biomed Chromatogr
ABSTRACT A precise, robust, and stability‐indicating liquid chromatographic (LC) method coupled with a photodiode array (PDA) detector was developed and validated for the quantitative estimation of rifapentine, an essential therapeutic agent for both active and latent tuberculosis (TB).
Korikana S, Battula S, Konduru N, Kurnool A, Vemuri D, Dantinapalli V.   +5 more
europepmc   +2 more sources

An analytical quality by design (aQbD) approach for a l -asparaginase activity method [PDF]

Journal of Pharmaceutical and Biomedical Analysis, 2016
L-asparaginase is an effective anti-tumor agent for acute lymphoblastic leukemia. This work presents the development of an activity determination of L-ASNase preparations for pharmaceutical quality control purposes, in accordance with analytical Quality by Design principles.
Han Yao, Jochem Vancoillie, Matthias D’Hondt, Evelien Wynendaele, Nathalie Bracke, Bart De Spiegeleer   +5 more
openaire   +3 more sources

Quality by Design (QbD) Based Method for Estimation of Xanthohumol in Bulk and Solid Lipid Nanoparticles and Validation

Molecules, 2023
The analytical quality by design (AQbD) approach is utilized for developing and validating the simple, sensitive, cost-effective reverse-phase high performance liquid chromatographic method for the estimation of xanthohumol (XH) in bulk and ...
Vancha Harish, Waleed Hassan Almalki, Ahmed Alshehri, Abdulaziz Alzahrani, Madan Mohan Gupta, Sami I. Alzarea, Imran Kazmi, Monica Gulati, Devesh Tewari, Gaurav Gupta, Kamal Dua, Sachin Kumar Singh   +11 more
doaj   +1 more source

Quality by design‐guided development of a capillary electrophoresis method for the simultaneous chiral purity determination and impurity profiling of tamsulosin

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. From initial scouting experiments, a dual cyclodextrin (CD) system composed of sulfated β‐CD and carboxymethyl‐α‐CD ...
Adriana Modroiu, Sulaiman Krait, Gabriel Hancu, Gerhard K. E. Scriba   +3 more
wiley   +1 more source

Strategies for capillary electrophoresis: Method development and validation for pharmaceutical and biological applications—Updated and completely revised edition

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, Holger Zagst, Matthias Stein, Ratih Ratih, Robert Minkner, Mais Olabi, Sophie Hartung, Christin Scheller, Blanca H. Lapizco‐Encinas, Cari Sänger‐van de Griend, Carlos D. García, Hermann Wätzig   +11 more
wiley   +1 more source