Results 81 to 90 of about 833 (196)

Potency Assay Variability Estimation in Practice

Pharmaceutical Statistics, Volume 24, Issue 1, January/February 2025.
Abstract During the drug development process, testing potency plays an important role in the quality assessment required for the manufacturing and marketing of biologics. Due to multiple operational and biological factors, higher variability is usually observed in bioassays compared with physicochemical methods.
Hang Li, Tomasz M. Witkos, Scott Umlauf, Christopher Thompson   +3 more
wiley   +1 more source

Selectivity study on thermochemical conversion of fruit residues (Plums) to platform chemicals (HMF) [PDF]

, 2023
5-hydroxymethylfurfural (HMF) is one of the versatile platform compounds derived from the dehydration of carbohydrates originating from biomass. However, the non-selective production of HMF from carbohydrates and its subsequent separation from the ...
Bebizuh, Dawit Firemichael
core  

Isolation, Identification, and Characterization of Forced Degradation Products of Bosentan by Using Advanced Analytical Techniques

SEPARATION SCIENCE PLUS, Volume 7, Issue 10, October 2024.
ABSTRACT The present study explains the degradation behavior of bosentan (BOS), active pharmaceutical ingredient (API) (BOS monohydrate), a Food and Drug Administration (FDA)–approved drug used for the treatment of chronic heart failure, subarachnoid hemorrhage, and Raynaud's syndrome pulmonary hypertension. The stress study was performed under various
Rajesh Kanagaddi, Satya Sree Nannapaneni, Jayaprakash Kanijam Raghupathi, Naresh Kumar Katari, Suresh Salakolusu, J. N. S. R. C. Murty, Mahesh Ranga, Muralidharan Kaliyaperumal   +7 more
wiley   +1 more source

DEVELOPMENT OF UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF BENIDIPINE HYDROCHLORIDE BY USING QUALITY BY DESIGN (QbD) APPROACH [PDF]

, 2018
Objective: To develop a simple, rapid, accurate, robust and inexpensive spectrophotometric method for the estimation of benidipine hydrochloride by using quality by design (QbD)†approach.Methods: A UV spectrophotometric method was developed on Shimadzu
Bishnoi, Ram Singh, Jain, C. P., Kumar, Manish, Shukla, Ajay Kumar   +3 more
core   +3 more sources

Analytical quality by design (AQbD) assisted RP-HPLC technique for quantification of Picroside II in bulk and pharmaceutical dosage form

Future Journal of Pharmaceutical Sciences
Background Quality by design (QbD) adverts toward gaining of few expected quality with predetermined and desired specifications. Analytical quality by design (AQbD) approach toward the development of analytical method can significantly lead toward the ...
Sharib Raza Khan, Shailesh Dadge, Shivam Rathaur, Jiaur R. Gayen   +3 more
doaj   +1 more source

Analytical Quality by Design approach in the development of a green reversed-phase ultra-high performance liquid chromatography/high-resolution time-of-flight mass spectrometry method for the simultaneous analysis of synthetic antimicrobial and hypotensive peptides

Journal of Chromatography Open
The growing therapeutic interest in peptides from Tityus stigmurus scorpion venom and their analogues highlights the need for the development of robust analytical methods for these compounds.
Ana Roberta Pereira Johnson dos Anjos, Márcia Natália da Silveira Pinto, Dayanne Lopes Porto, Fabio Santos de Souza, Rui Oliveira Macedo, Matheus de Freitas Fernandes Pedrosa, Cícero Flávio Soares Aragão   +6 more
doaj   +1 more source

Implementation of Quality by Design (QbD) approach to the analytical method development and validation for the estimation of Remogliflozin Etabonate in tablet dosage form by HPLC [PDF]

Analytical Quality by Design is a recent concept related to the development and validation of the analytical procedures (AQbD). This is done in analytical QbD by defining quality targets which enable the performance of the analytical procedure within the
Yash M. Phulwani, Shankar S. Yelmame, Laxmikant B. Borse
core   +2 more sources

A sustainable AQbD-based UHPLC–MS/MS method for the determination of hallucinogenic phenethylamines in urine

Open Chemistry
A systematic Analytical Quality by Design (AQbD) approach was applied to the development and validation of a UHPLC–MS/MS method for the determination of hallucinogenic phenethylamine-derived novel psychoactive substances in urine. Owing to the continuous
Kostić Emilija, Milosavljević Biljana, Simić Jovana, Vujović Maja   +3 more
doaj   +1 more source

IMPLEMENTING OF ANALYTICAL QUALITY BY DESIGN FOR HIGH QUALITY PHARMACEUTICAL PRODUCTS [PDF]

The quality in the pharmaceutical industry has become a very important topic. Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy.
P. Abhinandana1.2*, Ramarao Nadendla2
core   +1 more source

A-QbD-based green RP-HPLC method for estimation of rivaroxaban in pharmaceutical dosage forms

Discover Chemistry
This work reports the Analytical Quality by Design (AQbD) based green RP-HPLC method for Rivaroxaban, aimed at delivering a sustainable and robust analytical approach.
Yukta Vijay Kotecha, Dinesh Dattatray Rishipathak, Rakesh Uttamrao Shelke, Vijay Arjun Bagul, Anand Radheshyam Tiwari, Suryakant D. Bhosle   +5 more
doaj   +1 more source