Results 51 to 60 of about 529 (166)

Analytical Quality by Design (AQbD) for Quality and Risk Assessment of Pharmaceuticals to Immunomarkers

Journal of Pharmaceutical and Biopharmaceutical Research
Using advanced scientific and risk-based approaches for analytical methods offers significant benefits. Quality by Design (QbD) is a systematic framework that emphasizes understanding and controlling both product and process elements. Adhering to the principles outlined in the ICH guidelines can considerably improve the quality of drug substances ...
Vivekanandan Kalaiselvan, Meenakshi Dahiya, Gaurav Sanjay Mahalpure, Ritu Tiwari   +3 more
openaire   +1 more source

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 and Validation of a Stability Indicating Analytical Method for the Estimation of Gliclazide and Sitagliptin in Bulk Drugs and Tablet Dosage Forms by RP-UPLC: An Application of the Quality-by-Design Approach [PDF]

Sitagliptin and gliclazide are the active ingredients in OpdualagTM. A highly selective DPP-4 inhibitor, sitagliptin is thought to work in type 2 diabetics by delaying the inactivation of incretin hormones, which increases their concentration and ...
Nunsavathu, Sambasiva Naik, Rajaganapathy, Dr. K.   +1 more
core   +2 more sources

Analytical Lifecycle Management (ALM) and Analytical Quality by Design (AQbD) based Analytical Method Development for Separation of Related Substances in Amodiaquine Hydrochloride along with its Degradation Products and Structural Elucidation by LC-Quadrupole-Time of Flight-Tandem Mass Spectrometry

Asian Journal of Chemistry, 2023
The current study aimed to develop a robust, regulatory-flexible, stability-indicating ultra high performance liquid chromatography (UHPLC) analytical procedure compatible with mass spectrometry for the determination of impurities in amodiaquine hydrochloride using analytical lifecycle management (ALM) and analytical quality by design (AQbD) principles.
Jaya Raju Cheerla, T. Bhaskara Rao, P. Sanath Kumar Goud   +2 more
openaire   +1 more source

OPTIMIZING RP-HPLC TECHNIQUES FOR RELIABLE ANALYSIS OF DIABETES MEDICATIONS [PDF]

Introduction: A robust and precise RP-HPLC method was developed for the simultaneous quantification of Metformin, Vildagliptin, and Remogliflozin in pharmaceutical formulations, essential for managing Type 2 Diabetes Mellitus (T2DM).
Venkata sai suresh kumar sista* , Anjali jha, V LNSH Hari Haran. A, R S K Sharma , Anindita Chatterjee, G V Siva Prasad, K. Satyam Naidu, R. Sarada
core   +2 more sources

Developing health service delivery in a poor and marginalised community in North West Pakistan [PDF]

, 2018
Objective: To improve maternal health and reduce child mortality through developing health service delivery in a poor and marginalised community in North West Pakistan.
Bingley, Helen, Lowe, Nicola M, Medhi, Rashid, Ohly, Heather, Ul Haq, Zia, Zaman, Mukhtiar   +5 more
core   +1 more source

Analytical Quality by Design (AQbD) of the TLCScanner Method for the Determination of Radiochemical Purity of the Radiopharmaceutical Sodium Iodide 131I Oral Solution

, 2023
The objective of the study was to apply the principles of analytical quality by design (AQbD) to the analytical method for the determination of the radiochemical purity (PQR) of the radiopharmaceutical sodium iodide 131I oral solution, by means of thin layer chromatography (TLC) with a Radio-TLC scanner, the same one that allows to evaluate the quality
Miguel Vasquez, Américo Castro-Luna, Norma Julia Ramos-Cevallos, Donald Ramos-Perfecto, Mario Alcarraz-Curi, Jacqueline Segura-Vasquez, Danny Cáceres-Antaurco   +6 more
openaire   +1 more source

Implementation of Analytical Quality by Design (AQbD) approach to RP-HPLC method for dissolution testing

, 2015
Quality by Design (QbD) principles were implemented in RP-HPLC method development for the analysis of dissolution samples of immediate release film-coated tablets. Critical method variables and critical method attributes were identified. After the initial risk assessment, a DoE (design of experiments) study was performed to investigate the impact of ...
Pranjić, Josip, Radošević, Senka, Lusina Kregar, Maja   +2 more
openaire   +2 more sources

An analytical quality by design approach towards a simple and novel HPLC-UV method for quantification of the antifibrotic peptide N-acetyl-seryl-aspartyl-lysyl-proline [PDF]

, 2022
N-acetyl-seryl-aspartyl-lysyl proline (Ac-SDKP) is a tetrapeptide possessing anti-fibrotic, angiogenic, anti-inflammatory, anti-apoptotic, and immunomodulatory properties. Currently, the main method to quantify the peptide is liquid chromatography-tandem
Abukhamees, Shorooq, Craig, Duncan QM, Day, Richard M, Kenneth Ho, Hei Ming, Sembi, Satinder   +4 more
core  

Implementation of at-line capillary zone electrophoresis for fast and reliable determination of adenovirus concentrations in vaccine manufacturing [PDF]

, 2019
A CZE method was validated and implemented for fast and accurate in-process determination of adenovirus concentrations of downstream process samples obtained during manufacturing of adenovirus vector-based vaccines.
Backus, Harold, Galindo Garre, Francisca, Germano, Marta, Geurink, Lars, Schenning, Martijn, Somsen, Govert W., Sänger – van de Griend, Cari E., van Tricht, Ewoud   +7 more
core   +3 more sources