Analytical Methods for Nitrosamines and NDSRIs in Pharmaceuticals
A special issue of Separations (ISSN 2297-8739). This special issue belongs to the section "Analysis of Natural Products and Pharmaceuticals".
Deadline for manuscript submissions: 20 March 2027 | Viewed by 91
Editors
Interests: bioactive peptides; peptidomimetics; small-molecule organic synthesis; mycotoxin analysis; proteomics; nanoparticles; drug delivery; polymers
Special Issues, Collections and Topics in MDPI journals
Interests: forensic and clinical toxicology; pharmaceutical analysis; metabolomics; therapeutic drug monitoring; chemometrics; mass spectrometry
Special Issue Information
Dear Colleagues,
Nitrosamine drug substance-related impurities (NDSRIs) have emerged as one of the most critical challenges in pharmaceutical quality control due to their genotoxic and potentially carcinogenic properties. Following regulatory alerts from agencies such as the FDA and EMA, the pharmaceutical industry and academic research community have intensified efforts to develop sensitive, selective, and robust analytical methods capable of detecting and quantifying these impurities at trace levels in active pharmaceutical ingredients and drug products. This Special Issue aims to bring together original research articles, reviews, and short communications focused on analytical strategies for the detection, quantification, and structural characterization of nitrosamines and NDSRIs. Topics of interest include, but are not limited to, chromatographic and mass spectrometric techniques (LC-MS/MS, GC-MS/MS, and high-resolution mass spectrometry (HRMS)), method development and validation according to ICH guidelines, trace-level quantitation approaches, novel sample preparation and extraction techniques, structural elucidation of unknown nitrosamine impurities, stability and formation monitoring studies, and analytical approaches supporting nitrosamine elimination and mitigation strategies. Contributions presenting innovative technologies, green analytical chemistry approaches, or comparative method evaluations are particularly encouraged. We welcome submissions from both academic and industrial researchers working in pharmaceutical analysis, quality control, and impurity profiling.
Dr. Yiannis Sarigiannis
Guest Editor
Dr. Georgios N. Rallis
Guest Editor Assistant
Manuscript Submission Information
Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 250 words) can be sent to the Editorial Office for assessment.
Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-anonymized peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Separations is an international peer-reviewed open access monthly journal published by MDPI.
Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.
Keywords
- nitrosamines
- NDSRIs
- LC-MS/MS
- GC-MS/MS
- HRMS
- pharmaceutical analysis
- impurity profiling
- method validation
- AQbD
Benefits of Publishing in a Special Issue
- Ease of navigation: Grouping papers by topic helps scholars navigate broad scope journals more efficiently.
- Greater discoverability: Special Issues support the reach and impact of scientific research. Articles in Special Issues are more discoverable and cited more frequently.
- Expansion of research network: Special Issues facilitate connections among authors, fostering scientific collaborations.
- External promotion: Articles in Special Issues are often promoted through the journal's social media, increasing their visibility.
- Reprint: MDPI Books provides the opportunity to republish successful Special Issues in book format, both online and in print.
Further information on MDPI's Special Issue policies can be found here.
