Results 101 to 110 of about 459 (187)

AQbD-guided stability indicating HPLC method for azelnidipine and chlorthalidone fixed-dose combination tablet: a green approach

Journal of Taibah University for Science
This study developed a stability-indicating RP-HPLC method for quantifying azelnidipine and chlorthalidone in fixed-dose formulations using Analytical Quality by Design (AQbD) principles.
Rajvi Agrawal, Rajendra Kotadiya
doaj   +1 more source

International Approaches to the Development, Validation, and Change Management of Analytical Procedures (Review)

Регуляторные исследования и экспертиза лекарственных средств
INTRODUCTION. In 2023, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published a new Guideline on Analytical Procedure Development (ICH Q14) and a revised version of the Guideline on ...
A. V. Fetisova, Zh. I. Aladysheva, N. V. Pyatigorskaya, O. A. Zyryanov, M. M. Marshalova   +4 more
doaj   +1 more source

A comprehensive RP-HPLC technique for analyzing disodium edetate and its degradation products in eye drops using AQbD and Six Sigma perspective

Reviews in Analytical Chemistry
The study presents the development of a novel, sustainable, and analytical quality by design (AQbD) driven RP-HPLC method to simultaneously identify disodium edetate in eye drops and its degradation products.
Alanazi Tahani Y. A., Alluhayb Abdullah H., Alsehli Bandar R., Binsaleh Ammena Y., Saleh Sayed M., Mohamed Mahmoud A.   +5 more
doaj   +1 more source

Analytical Quality by Design (AQbD): Principles, Tools and Case Studies

Quality by Design is a systematic approach used in pharmaceutical development that builds product quality into the formulation and manufacturing processes from the outset. Although its adoption is increasing within the generic drug industry, many professionals are still not deeply familiar with its principles or terminology.
openaire   +1 more source

Analytical Quality by Design (AQbD): A Contemporary Framework for Pharmaceutical Analytical Development

Analytical Quality by Design (AQbD) is a systematic, science- and risk-based approach for developing robust, reliable, and regulatory-compliant analytical methods in the pharmaceutical industry. Unlike traditional trial-and-error approaches, AQbD builds quality into the method from the beginning through predefined objectives, scientific understanding ...
openaire   +1 more source

ANALYTICAL QUALITY BY DESIGN (AQBD) APPROACH FOR LIFECYCLE MANAGEMENT OF PHARMACEUTICAL ANALYTICAL METHODS

The pharmaceutical industry has increasingly adopted science- and risk-based approaches to ensure the quality, safety, and efficacy of pharmaceutical products. One of the most widely implemented strategies is Quality by Design (QbD), which emphasises systematic product and process understanding during drug development.
openaire   +1 more source

ICH Q14-Based Development of a Chaotropic Chromatography Method for the Determination of Olanzapine and Its Two Oxidative Degradation Products in Tablets

Analytica
Impurity profiling is of significant analytical and regulatory importance, particularly in the context of lifecycle quality management. A robust chaotropic chromatography method was developed for the determination of olanzapine and its two oxidative ...
Milena Rmandić, Marija Rašević, Kostas Gkountanas, Ana Protić, Anđelija Malenović, Yannis Dotsikas   +5 more
doaj   +1 more source

Analytical Quality By Design To Characterize Inhalation Products [PDF]

, 2018
Dissertação de Mestrado em Biotecnologia Farmacêutica apresentada à Faculdade de FarmáciaO presente trabalho foi baseado no desenvolvimento de um método analítico utilizando a abordagem de Analytical Quality by Design (AQbD).
Gaspar, Joana Rita Mendes
core  

Sustainable RP-UPLC analysis of Nirogacestat for desmoid tumors using quality-by-design and green analytical chemistry

Green Chemistry Letters and Reviews
Quality-by-Design (QbD) and Green Analytical Chemistry (GAC) are used to develop a sustainable RP-UPLC method for detecting Nirogacestat hydrobromide (NGS) in bulk and pharmaceutical formulations.
Vanga Mohan Goud, Sarad Pawar Naik Bukke, Praveen Kumar Kusuma, Bayapa Reddy Narapureddy, Chandrashekar Thalluri   +4 more
doaj   +1 more source

RP-HPLC method development and validation of Abacavir, Lamivudine and Zidovudine in combined pharmaceutical dosage by analytical QbD

Discover Chemistry
An accurate, precise, robust, and green RP-HPLC method was developed for assessment of three antiviral medications, namely Abacavir (ABA), Lamivudine (LAMI), and Zidovudine (ZIDO) in combined pharmaceutical dosage form by Analytical Quality by Design ...
Divyesh Vanparia, Ronak R. Dedania, Zarna R. Dedania   +2 more
doaj   +1 more source