Critical review on establishment and availability of impurity and degradation product reference standards, challenges faced by the users, recent developments, and …
The reference standards of impurities (IMPs) and degradation products (DPs) are required
by pharmaceutical industry and quality testing laboratories the world over to comply with …
by pharmaceutical industry and quality testing laboratories the world over to comply with …
Mechanochemical Oxidative Degradation of Thienopyridine Containing Drugs: Toward a Simple Tool for the Prediction of Drug Stability
EF Krake, L Backer, B Andres, W Baumann… - ACS Central …, 2023 - ACS Publications
The long-term stability of an active-pharmaceutical ingredient and its drug products plays an
important role in the licensing process of new pharmaceuticals and for the application of the …
important role in the licensing process of new pharmaceuticals and for the application of the …
Study of degradation behaviour of montelukast sodium and its marketed formulation in oxidative and accelerated test conditions and prediction of physicochemical …
Study of oxidative stability of pharmaceutical actives and formulations is important as
oxidation pathway is the second most significant route for the decay of pharmaceuticals …
oxidation pathway is the second most significant route for the decay of pharmaceuticals …
Overview on Development and Validation of Force degradation studies with Stability Indicating Methods.
K Chandramore, S Sonawane - … Biotechnology Research Asia, 2022 - biotech-asia.org
This article provides an overview on Development and Validation of Force degradation
study with Stability Indicating Methods (SIMs) for drug substances. Different stress conditions …
study with Stability Indicating Methods (SIMs) for drug substances. Different stress conditions …
Stability behaviour of antiretroviral drugs and their combinations. 10: LC-HRMS, LC-MSn, LC-NMR and NMR characterization of fosamprenavir degradation products …
The present study focused upon the forced degradation behaviour of fosamprenavir (FPV),
an antiretroviral drug. A total of six degradation products (DPs) were separated on a non …
an antiretroviral drug. A total of six degradation products (DPs) were separated on a non …
Characterization of stress degradation products of amodiaquine dihydrochloride by liquid chromatography with high‐resolution mass spectrometry and prediction of …
V Dhiman, DK Singh, MK Ladumor… - Journal of separation …, 2017 - Wiley Online Library
The degradation behavior of amodiaquine dihydrochloride, an antimalarial drug, was
investigated in solution as well as solid states. The drug was subjected to hydrolytic …
investigated in solution as well as solid states. The drug was subjected to hydrolytic …
Implementation of design of experiments for optimization of forced degradation conditions and development of a stability‐indicating high‐performance liquid …
Sepiwhite is a novel anti‐pigmenting agent that is derived from fatty acid and phenylalanine
and used for hyperpigmentation induced by light exposure or inflammation. In this study, a …
and used for hyperpigmentation induced by light exposure or inflammation. In this study, a …
Insights into the degradation chemistry of tazarotene, a third generation acetylenic retinoid: LC-HRMS (Orbitrap), LC-MSn and NMR characterization of its degradation …
Tazarotene is a prodrug that belongs to the acetylenic class of retinoids. The drug was
subjected to hydrolytic, oxidative and photolytic stress testing to establish its comprehensive …
subjected to hydrolytic, oxidative and photolytic stress testing to establish its comprehensive …
Potential degradation products of abemaciclib: Identification and structural characterization employing LC-Q/TOF-MS and NMR including mechanistic explanation
Degradation products are the potential drug impurities that can be generated during
transport and storage of pharmaceuticals. Before this study, degradation chemistry and …
transport and storage of pharmaceuticals. Before this study, degradation chemistry and …
Identification, characterization, and high‐performance liquid chromatography quantification of process‐related impurities in vonoprazan fumarate
L Liu, N Cao, X Ma, K Xiong, L Sun… - Journal of Separation …, 2016 - Wiley Online Library
High‐performance liquid chromatography analysis of vonoprazan fumarate, a novel proton
pump inhibitor drug revealed six impurities. These were identified by liquid chromatography …
pump inhibitor drug revealed six impurities. These were identified by liquid chromatography …