Results 31 to 40 of about 299 (155)

Quality‐by‐Design Principles Applied to the Establishment of a Pharmaceutical Quality Control Laboratory in a Resource‐Limited Setting: The Lab Water

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, Sileshi Belew, Dereje Kebebe, Markos Duguma, Henok Teshome, Gemmechu Hasen, Evelien Wynendaele, Luc Duchateau, Bart De Spiegeleer, Eladia M. Pena Mendez   +9 more
wiley   +1 more source

The analysis of cannabinoids in cannabis samples by supercritical fluid chromatography and ultra‐high‐performance liquid chromatography: A comparison study

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, Cédric Schelling, Jean‐Marc Roussel, Amandine Dispas, Charlotte De Bleye, Éric Ziemons, Philippe Hubert, Jean‐Luc Veuthey   +7 more
wiley   +1 more source

Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

International Journal of Analytical Chemistry, 2015
Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach.
Ramalingam Peraman, Kalva Bhadraya, Yiragamreddy Padmanabha Reddy   +2 more
doaj   +1 more source

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

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

Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing

Journal of Chemistry, 2015
Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and PAT
N. V. V. S. S. Raman, Useni Reddy Mallu, Hanimi Reddy Bapatu   +2 more
doaj   +1 more source

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

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   +1 more source

Software-assisted analytical Quality by Design for stability-indicating method development: integration of DoE and predictive retention modeling using MODDE® and DryLab® [PDF]

Makedonsko Farmacevtski Bilten
In modern pharmaceutical development, the increasing complexity of drug substances, formulations, and regulatory expectations has rendered traditional one-factor-at-a-time (OFAT) approaches to analytical method development inefficient and increasingly ...
Dino Karpicarov, Ivana Mitrevska, Blagica Manchevska, Paulina Apostolova, Jasmina Tonic Ribarska, Biljana Gjorgjeska   +5 more
doaj   +1 more source

Development and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles

Molecules, 2021
A novel and efficient stability-indicating, reverse phase ultra-performance liquid chromatographic (UPLC®) analytical method was developed and validated for the determination of hexoprenaline in an injectable dosage form.
Jesús Alberto Afonso Urich, Viktoria Marko, Katharina Boehm, Raymar Andreína Lara García, Dalibor Jeremic, Amrit Paudel   +5 more
doaj   +1 more source

Experimental design in HPLC separation of pharmaceuticals [PDF]

Arhiv za farmaciju, 2021
Design of Experiments (DoE) is an indispensable tool in contemporary drug analysis as it simultaneously balances a number of chromatographic parameters to ensure optimal separation in High Pressure Liquid Chromatography (HPLC).
Stojanović Jevrem, Krmar Jovana, Protić Ana, Svrkota Bojana, Đajić Nevena, Otašević Biljana   +5 more
doaj   +1 more source