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

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

Author: Grafiati

Published: 7 June 2025

Last updated: 16 July 2025

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

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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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2

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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3

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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4

Maganti, Sivaji, Suryakala Duvvuri, Srivathsa Degekar Gouni, Pavani Kadupu, and M. Bhaskara Praveen Varma. "RP-HPLC Method for the Quantification of Impurities in Etelcalcetide Injection and a Comparative Characterization Study of In-House Samples of Etelcalcetide Injection with Reference-Listed Drug Samples." Asian Journal of Chemistry 37, no. 4 (2025): 968–74. https://doi.org/10.14233/ajchem.2025.33486.

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In present study, an accurate and simple reversed phase-high performance liquid chromatography (RP-HPLC) method for the determination of potential impurities resulting from etelcalcetide injection was validated. An Ace Excel 3 C18 amide column with 100% 0.1 M sodium perchlorate (pH 2.0) buffer (100%) was used as mobile phase A and a 60:10 (%v/v) ratio of acetonitrile and 0.1 M sodium perchlorate (pH 2.0) was used as mobile phase B. The wavelength detection performed at 210 nm. Etelcalcetide injection was subjected to thermal, photolytic, acid, base, and peroxide degradation conditions, which w

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Gao, Shenghua, Lili Meng, Chunjie Zhao, Tao Zhang, Pengcheng Qiu, and Fuli Zhang. "Identification, Characterization and Quantification of Process-Related and Degradation Impurities in Lisdexamfetamine Dimesylate: Identifiction of Two New Compounds." Molecules 23, no. 12 (2018): 3125. http://dx.doi.org/10.3390/molecules23123125.

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Twelve impurities (process-related and degradation) in lisdexamfetamine dimesylate (LDX), a central nervous system (CNS) stimulant drug, were first separated and quantified by high-performance liquid chromatography (HPLC) and then identified by liquid chromatography mass spectrometry (LC-MS). The structures of the twelve impurities were further confirmed and characterized by IR, HRMS and NMR analyses. Based on the characterization data, two previously unknown impurities formed during the process development and forced degradation were proposed to be (2S)-2,6-di-(lysyl)-amino-N-[(1S)-1-methyl-2

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Zhang, Dandan, Weijian Wang, Haiyun Zhao, et al. "Structural Identification of Impurities in Pioglitazone Hydrochloride Preparations by 2D-UHPLC-Q-Exactive Orbitrap HRMS and Their Toxicity Prediction." International Journal of Analytical Chemistry 2023 (October 17, 2023): 1–12. http://dx.doi.org/10.1155/2023/2096521.

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Pharmaceutical companies and regulatory agencies have more and more concerns for impurities in pharmaceuticals and their toxicity. In this work, heart-cutting two-dimensional ultrahigh-performance liquid chromatography (2D-UHPLC) in combination with high-resolution mass spectrometry (HRMS) was used, setting HRMS as positive mode of electrospray ionization to identify five impurities in pioglitazone hydrochloride preparations. With the heart-cutting 2D-UHPLC and online desalting technique, the structures of five impurities were deduced in an analysis of MSn data. And three of them, Impurity-2,

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Hong, Junting, Nadia Boussetta, Gérald Enderlin, Nabil Grimi, and Franck Merlier. "Real-Time Monitoring of the Atrazine Degradation by Liquid Chromatography and High-Resolution Mass Spectrometry: Effect of Fenton Process and Ultrasound Treatment." Molecules 27, no. 24 (2022): 9021. http://dx.doi.org/10.3390/molecules27249021.

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High resolution mass spectrometry (HRMS) was coupled with ultra-high-performance liquid chromatography (uHPLC) to monitor atrazine (ATZ) degradation process of Fenton/ultrasound (US) treatment in real time. Samples were automatically taken through a peristaltic pump, and then analysed by HPLC-HRMS. The injection in the mass spectrometer was performed every 4 min for 2 h. ATZ and its degradation metabolites were sampled and identified. Online Fenton experiments in different equivalents of Fenton reagents, online US experiments with/without Fe2+ and offline Fenton experiments were conducted. Hig

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Meijer, Nils W. F., Susan Zwakenberg, Johan Gerrits, et al. "Direct Infusion Mass Spectrometry to Rapidly Map Metabolic Flux of Substrates Labeled with Stable Isotopes." Metabolites 14, no. 5 (2024): 246. http://dx.doi.org/10.3390/metabo14050246.

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Direct infusion–high-resolution mass spectrometry (DI-HRMS) allows for rapid profiling of complex mixtures of metabolites in blood, cerebrospinal fluid, tissue samples and cultured cells. Here, we present a DI-HRMS method suitable for the rapid determination of metabolic fluxes of isotopically labeled substrates in cultured cells and organoids. We adapted an automated annotation pipeline by selecting labeled adducts that best represent the majority of 13C and/or 15N-labeled glycolytic and tricarboxylic acid cycle intermediates as well as a number of their derivatives. Furthermore, valine, leuc

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Gandhi, Santosh Kumar, and Badal Kumar Mandal. "Identification and Structural Characterization of Forced Degradation Impurities of Sacubitril by HRMS – Development and Validation of a Stability indicating RP-HPLC method." Research Journal of Chemistry and Environment 27, no. 12 (2023): 169–79. http://dx.doi.org/10.25303/2712rjce1690179.

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The current work identifies and characterises the stress degradation products of the anti-hypertensive drug sacubitril. The stability profile of sacubitril was evaluated under several stress settings including hydrolytic, oxidative, thermal and photolytic conditions in accordance with ICH recommendations. The degradation products of sacubitril were separated using reverse phase liquid chromatography and structural characterization was carried out using HRMS. The chromatographic separation was carried out by Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) using a Fortis C18 colum

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Mesonzhnik, Natalia, Anton Belushenko, Polina Novikova, Alexey Kukharenko, and Mikhail Afonin. "Enhanced N-Glycan Profiling of Therapeutic Monoclonal Antibodies through the Application of Upper-Hinge Middle-Up Level LC-HRMS Analysis." Antibodies 13, no. 3 (2024): 66. http://dx.doi.org/10.3390/antib13030066.

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Therapeutic monoclonal antibodies (mAbs) are crucial in modern medicine due to their effectiveness in treating various diseases. However, the structural complexity of mAbs, particularly their glycosylation patterns, presents challenges for quality control and biosimilarity assessment. This study explores the use of upper-hinge middle-up (UHMU)-level ultra-high-performance liquid chromatography–high-resolution mass spectrometry (LC-HRMS) analysis to improve N-glycan profiling of mAbs. Two specific enzymes, known as IgG degradation enzymes (IGDEs), were used to selectively cleave therapeutic mAb

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Book chapters on the topic "High-Resolution Mass Spectrometry (HRMS) degradation impurities"

1

Chen, Guodong, and Birendra N. Pramanik. "Structural Characterization of Impurities and Degradation Products in Pharmaceuticals Using High-Resolution LC-MS and Online Hydrogen/Deuterium Exchange Mass Spectrometry." In Characterization of Impurities and Degradants Using Mass Spectrometry. John Wiley & Sons, Inc., 2011. http://dx.doi.org/10.1002/9780470921371.ch5.

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