Analytical chemistry in pharmaceutical analysis deals with the investigation of bulk drug materials, active pharmaceutical ingredients, intermediates, drug products, including their impurities and degradation products, to address the different qualitative and quantitative descriptors of medicines. This task falls in the overarching concept of quality, which is crucial to ensure that safe and effective drugs are released to the market. Analytical chemistry plays a fundamental role in supporting the thorough characterisation of medicines used in the toxicological/clinical studies and in the market. The recent outbreak of nitrosamines impurities highlighted the challenges of measuring minute concentrations at low detection limits in complex matrices.

Recently, several approaches have been developed to address the multifaceted features of the quality of medicines as structural analysis, content, impurity profile -including stereochemical impurities- suitability of the container closure systems and degradation patterns. However, new challenges continue to emerge and a number knowledge gaps are still at the forefront of the scientific and regulatory community.

The analytical needs are multifaceted. In pharmaceutical research the characterisation and monitoring of impurities including polymorphic forms, stereoisomers are in focus of the quality domain being the latter difficult to address due to structural similarities with the active substance. Furthermore, the control of small amounts of potentially toxic impurities in finished products is often challenging and requires specific and sensitive analytical methods. The application of nanotechnologies in drug development may require complementary techniques to address nanospecific issues. On the regulatory side, the annual marketing surveillance programmes for human and veterinary medicines entail high throughput techniques to screen the ever-increasing number of samples with variable compositions. The substandard production and falsification of human and veterinary medicines are still on the increase, therefore fast and reliable screening tools for the unambiguous identification and quantitation of declared or undeclared active substances are necessary. In all cases, untargeted analytical approaches could show unexpected impurities at undue level. Therefore, advances in hyphenated techniques such as gas (GC) and liquid (LC) chromatography coupled to mass spectrometry (MS), nuclear magnetic resonance (NMR), Fourier transform infrared (FTIR), Inductively Coupled Mass Spectrometry (ICP-MS), Raman spectroscopy, to name the most common, are promising areas of research.

The goal of this Research Topic is to explore major breakthroughs and novel applications of analytical chemistry to address new challenges and recent advances in pharmaceutical analysis. Different analytical methodologies encompassing innovative, and suitable chemical approaches will be gathered to support optimized sample preparation protocols, detection, quantification, data processing and statistical analysis. Special attention will be paid to inorganic and organic mass spectrometry, spectroscopy (e.g NMR, IR, Raman) and chromatography in order to build knowledge on chemical medicines, peptides, polysaccharides and herbal products. The proposed research will have the potential to be recognised as a scientific benchmark for assessing the quality of medicines.

This Research Topic collection will cover chromatographic, fractionation, spectroscopic, spectrometric, -omic sciences, elemental analysis, multivariate statistical and chemometric tools applied in the analysis of pharmaceuticals. Quantitative and qualitative analyses that include sample preparation, analytical instrumentation, and data processing will also be considered. Lastly, applications to case studies and market surveillance studies are in the scope of the topic collection. Biological methods are out of scope for this Research Topic.

We welcome Original Research, Review, Mini Review and Perspective articles on themes including, but not limited to:

• Spectroscopy and Spectrometry techniques for the quantitative and qualitative characterisation of active pharmaceutical ingredients and medicinal products.

• Sample preparation

• Surveillance studies encompassing newly developed analytical methods

• Falsification of medicines

• Detection and quantification of chemical impurities (organic, stereochemical and elemental)

• Chemical characterisation of nanomedicines

Submit your idea

Impact

Frontiers in Chemistry

Submit your idea

Impact