Impurity profiling includes a description of the identified and unidentified impurities present in new drug substances or drug products. Isolation and elucidation of the structures of degradation products are typically collaborative research involving knowledge of analytical, organic and physical chemistry with spectroscopic information. Stability testing guidelines issued by International Conf...

Pharmaceutical drugs are available to astronauts to help them overcome the deleterious effects of weightlessness, sickness and injuries. Unfortunately, recent studies have shown that some of the drugs currently used may degrade more rapidly in space, losing their potency before their expiration dates. To complicate matters, the degradation products of some drugs can be toxic. Here, we present a...

In this paper, an application of Quality by Design (QbD) concepts to the development of a stability indicating HPLC method for a complex pain management drug product containing drug substance, two preservatives, and their degradants is described. The QbD approach consisted of (i) developing a full understanding of the intended purpose, (ii) developing predictive solutions, (iii) designing a mea...

A new degradant of Nafcillin Sodium was found at a level of 1.8% w/w during the gradient reversed-phase HPLC analysis in stability storage samples. This impurity was identified by LC-MS and was characterized by (1)H-NMR, (13)C-NMR, LC/MS/MS, elemental analysis, and IR techniques. Based on the structural elucidation data, this impurity was named as N-[(2S)-2-carboxy-2-{[(2-ethoxynaphthalen-1-yl)...

In this study, PP films were modified with an organic pro-degradant in different concentrations (1, 2 and 3 wt.%), exposed in the first step of degradation to natural ageing for 100 days followed by biodegradation in simulated soil in the respirometric test for 100 days. At the end of the combined degradation process the PP samples were characterized according to their morphological and physica...

DOI: 10.1002/sscp.202100018 The cover picture shows a densitogram of base hydrolyzed sample Ibrutinib that has well separated drug and degradant peak.

Olanzapine (OLZ) is amongst the most commonly prescribed antipsychotic drugs and is associated with substantial instability. The aim of this study was to investigate the instability of OLZ and to identify the degradants formed from its breakdown. Three experiments were conducted to monitor the degradation of OLZ and the formation of degradants in blood (1), water (2), and post-extraction at 4 °...

in this study, pp films were modified with an organic pro-degradant in different concentrations (1, 2 and 3wt.%), exposed in the first step of degradation to natural ageing for 100 days followed by biodegradation insimulated soil in the respirometric test for 100 days. at the end of the combined degradation process the pp sampleswere characterized according to their morphological and physical p...

The objective of this two-part review article is to provide guidance for isolating and identifying process related impurities and degradation products from pharmaceutical drug candidates. The identification of degradation products can provide an understanding of impurity formation and define degradation mechanisms. If the identification process is performed at an early stage of drug development...

Three competing mathematical fitting models (a point-by-point estimation method, a linear fit method, and an isoconversion method) of chemical stability (related substance growth) when using high temperature data to predict room temperature shelf-life were employed in a detailed comparison. In each case, complex degradant formation behavior was analyzed by both exponential and linear forms of t...