A steady increase of product titers and the corresponding change in impurity composition
represent a challenge for development and optimization of antibody production processes …

A forced degradation study is an essential step in the design of a regulatory compliant
stability program for both drug substances and products, and was formalized as a regulatory …

With ever increasing regulatory and compendial stringency on the control of impurities
(IMPs) and degradation products (DPs)(including genotoxic impurities) in drug substances …

The analysis of host cell proteins (HCPs) is one of the most important analytical
requirements during bioprocess development of therapeutic moieties. In this review, we …

Drug impurity and degradation profiling mean the detection, structure elucidation and
quantitative determination of impurities and degradation products in bulk drug materials and …

Liquid chromatography–mass spectrometry (LC–MS) is considered today as a mainstay tool
for the structure characterization of minor components like impurities (IMPs) and degradation …

Clopidogrel bisulfate (CB) is a golden antiplatelet treatment, yet its benefits are limited by its
low bioavailability (< 50%) caused by poor intestinal solubility and absorption. The present …

Biosynthesis of nanoparticles is increasingly becoming popular due to the demand for
sustainable technologies worldwide. In the present investigation, Acmella oleracea plant …

Reactive impurities, such as hydrogen peroxide in excipients, raise a great concern over the
chemical stability of pharmaceutical products. Traditional screening methods of spiking …

The present study aimed to investigate methods for accelerating autoxidation of crystalline
drugs in the solid-state that can potentially predict real− time stability. Solid droperidol (DPD) …