Impurities in Active Pharmaceutical Ingredients and Drug Products: A Critical Review

C Finotti Cordeiro, L Lopardi Franco… - Critical Reviews in …, 2024 - Taylor & Francis
The presence of impurities in active pharmaceutical ingredients (APIs) and drug products
represents a risk to patients' health. Such substances are related to diverse side effects and …

Recent Progresses in analytical perspectives of degradation studies and impurity profiling in pharmaceutical developments: An updated review

M Jahani, BS Fazly Bazzaz, M Akaberi… - Critical Reviews in …, 2023 - Taylor & Francis
Forced degradation studies have been used to simplify analytical methodology development
and achieve a deeper knowledge about the inherent stability of active pharmaceutical …

Identification and characterization of forced degradation products of sertraline hydrochloride using UPLC, ultra-high-performance liquid chromatography-quadrupole …

P Grover, M Bhardwaj, D Mukherjee - Journal of Pharmaceutical and …, 2022 - Elsevier
The present study focused on the forced degradation behavior of sertraline hydrochloride
(SRT), selective serotonin reuptake inhibitor (SSRI). The drug was exposed to different …

LC-MS/MS studies for identification and characterization of new forced degradation products of dabrafenib and establishment of their degradation pathway

P Grover, M Bhardwaj, L Mehta - Journal of Pharmaceutical and Biomedical …, 2021 - Elsevier
Dabrafenib (Tafinlar) is used for the treatment of patients with BRAF V600 mutation positive
unresectable or metastatic melanoma. Forced degradation study of the drug product and …

Identification and characterization of new degradation products of belinostat using UHPLC-Q-TOF-MS/MS and in silico toxicity prediction

L Mehta, T Naved, P Grover, M Bhardwaj… - Journal of Liquid …, 2021 - Taylor & Francis
Belinostat is a histone deacetylase inhibitor used for the management of hematological
malignancies and solid tumors. In the current study, stability-indicating ultra-performance …

In-vivo pharmacokinetic study of ibrutinib-loaded nanostructured lipid carriers in rat plasma by sensitive spectrofluorimetric method using harmonized approach of …

P Prajapati, A Patel, A Desai, P Shah, VS Pulusu… - … Acta Part A: Molecular …, 2024 - Elsevier
Ibrutinib, an antineoplastic agent tackling chronic lymphocytic leukemia, mantle cell
lymphoma, and Waldenstrom's Macroglobulinemia, falls under the category of BCS class II …

Selection of appropriate post-harvest processing methods based on the metabolomics analysis of Salvia miltiorrhiza Bunge

S Qiu, Y Tu, D Huang, Z Dong, M Huang… - Food Research …, 2021 - Elsevier
Post-harvest processing is a leading cause of metabolic changes and quality loss in food
products. An untargeted metabolomics approach based on UHPLC-QTOF-MS was …

LC and LC-MS/MS studies for identification and characterization of degradation products of d-tubocurarine chloride

P Grover, S Maheshwari, K Nagarajan, L Mehta… - … of Pharmaceutical and …, 2023 - Elsevier
Forced degradation studies of d-tubocurarine (DTC) was carried out in hydrolytic (acidic,
alkaline and neutral), thermal, photolytic and oxidative degradation conditions as per …

[PDF][PDF] Development and validation of novel and highly sensitive stability-indicating reverse phase ultra performance liquid chromatography method for quantification …

L Mehta, T Naved, P Grover, M Bhardwaj… - Indian Journal of …, 2020 - academia.edu
In present study, a novel, simple, robust, stability-indicating, highly sensitive and specific
reverse phase ultra-performance liquid chromatographic method was established and …

[PDF][PDF] Development and validation of novel and highly sensitive stability-indicating reverse phase UPLC method for quantification of Dabrafenib and its ten …

P Grover, M Bhardwaj, L Mehta… - Indian Journal of …, 2022 - pdfs.semanticscholar.org
Objectives: Dabrafenib is used as an active pharmaceutical ingredient acts as an inhibitor of
the associated enzyme B-Raf, which plays a role in the regulation of cell growth. In the …