Relevant bibliographies by topics / High-Resolution Mass Spectrometry (HRMS) degradation impurities. pharmaceutical applications

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Academic literature on the topic 'High-Resolution Mass Spectrometry (HRMS) degradation impurities. pharmaceutical applications'

Author: Grafiati
Published: 7 June 2025
Last updated: 2 August 2025

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Journal articles on the topic "High-Resolution Mass Spectrometry (HRMS) degradation impurities. pharmaceutical applications"

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P., Chandrashekhar Reddy*1 2. G. Sampath Kumar Reddy3 and B. Jainendra Kumar 4. "Advancements in HPLC Techniques for Detecting and identification of Process-Related and Degradants Impurities in Pharmaceutical Compounds." International Journal of Pharmaceutical Sciences 3, no. 2 (2025): 527–46. https://doi.org/10.5281/zenodo.14834264.

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Advancements in High-Performance Liquid Chromatography (HPLC) have significantly improved the detection, identification and quantification of process-related impurities and degradants in pharmaceuticals. Key innovations include Ultra-High-Performance Liquid Chromatography (UHPLC), which provides enhanced resolution and sensitivity, and multi-dimensional chromatography for better separation of complex mixtures. The integration of HPLC with Mass Spectrometry, particularly LC-MS/MS and High-Resolution Mass Spectrometry (HRMS), enables precise identification and quantification of impurities at tra
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Bosc-Bierne, Gaby, and Michael G. Weller. "Investigation of Impurities in Peptide Pools." Separations 12, no. 2 (2025): 36. https://doi.org/10.3390/separations12020036.

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Peptide pools are important research tools in different biomedical fields. They consist of a complex mixture of defined peptides, which places high demands on the production and quality control of these products. Previously it has been shown that the combination of UHPLC with high-resolution mass-spectrometry (HRMS) is a fast and powerful method to confirm the relative concentration and the structural identity of all peptides expected to be in the pool. In this work, the additional information contained in the UV chromatograms and mass spectra is used to search for impurities due to synthesis
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Sharavanan, Selliamman Palaniyandi Nallusamy, Chidambaram Subramanian Venkatesan, Singaram Sathiyanarayanan, and Senthamaraikannan Kabilan. "Potential Impurities of Tigecycline: Synthesis, Isolation, Characterization and In Vitro Pharmacological Evaluation." Current Pharmaceutical Analysis 16, no. 6 (2020): 730–42. http://dx.doi.org/10.2174/1573412915666190225160030.

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Background: Tigecycline is a known antibiotic in the tetracycline family and a chemical analog of minocycline. It may be used for the treatment against drug-resistant bacteria. Methods: HPLC method was used for related substance analysis. The degraded impurities during the process were isolated and characterized by IR, HRMS (High Resolution Mass Spectrometry) and NMR spectral analysis. Results: Four impurities of tigecycline, a broad spectrum antibacterial agent, were identified, synthesized and characterized. The in vitro biological evaluation of the isolated compounds showed significant anti
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Liana, Aleksandra, Adam Hałuszczuk, Andrzej Gawor, and Ewa Bulska. "Identification and Structural Characterization of Degradation Products of Linagliptin by Mass Spectrometry Techniques." International Journal of Molecular Sciences 25, no. 5 (2024): 2591. http://dx.doi.org/10.3390/ijms25052591.

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As part of the development and production of pharmaceuticals, the purity of Active Pharmaceutical Ingredients stands as a fundamental parameter that significantly influences the quality, safety, and efficacy of the final drug product. Impurities in Active Pharmaceutical Ingredients are various unwanted substances that can appear during the whole manufacturing process, from raw materials to the final product. These impurities can stem from multiple sources, including starting materials, intermediates, reagents, solvents, and even degradation products resulting from exposure to environmental fac
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Harshad, Tanpure* Dr. Vishwas Bahgat Dr. Deepak Kardile Dr. Rajkumar Shete M. M. Karne. "Revolutionizing Stability-Indicating Analysis: Advanced RP-HPLC Strategies for Pharmaceutical Excellence." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 4466–89. https://doi.org/10.5281/zenodo.15522235.

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Stability-indicating analysis is vital to pharmaceutical quality control for establishing the safety, efficacy, and quality of pharmaceutical drug products until their expiration date. Reversed-phase high-performance liquid chromatography (RP-HPLC) has recently become an important tool in stability testing because of its high selectivity, sensitivity, and robustness. Abstract/Short: This review focused on recent developments in RP-HPLC approaches for stability-indicating analysis to emphasize their importance in pharmaceutical excellency. Abstract The principles of stability-ind
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Upadhyay, Kalpesh, Jaswandi Mehetre, Vimal Kumar, Tushar Mehta, Anirban Roy Chowdhury, and Keyur Ahir. "Various Analytical Techniques used for Nitrosamine impurities in Pharmaceutical Dosage Forms: A Comprehensive Review." Asian Journal of Pharmaceutical Analysis, May 10, 2025, 131–36. https://doi.org/10.52711/2231-5675.2025.00021.

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Nitrosamine impurities are a class of substances formed from the reaction of a nitroso compound and secondary or tertiary amines under acidic conditions. The detection of nitrosamine impurities in Active Pharmaceutical Ingredients (APIs) and Finished Pharmaceuticals (FP) has raised significant health concerns due to their potent genotoxic carcinogenic properties. The presence of low concentration levels of nitrosamine impurities has led to drug withdrawals and extensive investigations into their formation. For the estimation of such low level of impurities led to development of highly sensitiv
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Xia, Jiaxuan, Yibao Jin, Yanjun Hong, et al. "Application of Advanced High‐Resolution Mass Spectrometric Techniques for the Analysis of Losartan Potassium Drug Substance Degradation Products: From Nontargeted to Targeted Screening." Journal of Separation Science 47, no. 23 (2024). https://doi.org/10.1002/jssc.70027.

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ABSTRACTAdvances in techniques for quality analysis allow for a more detailed examination of drug impurities. High‐resolution mass spectrometry (HRMS) contributes to detecting both known and unknown impurities. In this study, a combination of a nontargeted and targeted screening approach was established and applied to the detailed degradation profile of the losartan potassium (LP) drug substance. Through general unknown comparative screening (GUCS), 35 degradation products (DPs) were detected; of these, 10 DPs were confirmed with reference substances. DP‐1, DP‐2, DP‐3, and DP‐6 were the first
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8

Huang, Tyler C., Ayesha Nisathar, and Frank Rinaldi. "Identification and Characterization of Acidic Degradation Products of Moxidectin Drug Substance Including Degradation Pathways Using LC, HRMS, and NMR." Journal of AOAC International, December 3, 2024. https://doi.org/10.1093/jaoacint/qsae096.

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Abstract Background Moxidectin is an active pharmaceutical ingredient (API) extensively used in various drug products within the pharmaceutical and animal health sectors. Despite its widespread use, the analytical methods prescribed by the United States Pharmacopeia (USP) and European Pharmacopoeia (EP, Ph. Eur.) exhibit significant limitations. These methods fail to adequately separate key impurities of (23Z)-moxidectin (EP impurity L) and 3,4-epoxy-moxidectin, potentially affecting the quality control, purity assessment, and safety of moxidectin-containing products. Objective The objective w
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