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Journal articles on the topic 'Characterization of impurities'

Author: Grafiati

Published: 4 June 2021

Last updated: 25 July 2025

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1

Reddy, Nandyala Malyadri, K. R. S. Prasad, Ravi Sekhar Reddy Nandipati, et al. "Identification, Synthesis and Characterization of Novel Palbociclib Impurities." Asian Journal of Chemistry 37, no. 3 (2025): 698–706. https://doi.org/10.14233/ajchem.2025.33265.

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Palbociclib is used for breast cancer treatment along with letrozole. Five major impurities were observed during the synthesis as well as in forced degradation studies, out of which, three impurities were identified during the penultimate step of palbociclib API synthesis. These three impurities were confirmed as palbociclib desacetyl impurity (PDA impurity), palbociclib desacetyl hydroxy impurity (PDH impurity) and palbociclib desacetyl hydroxyl methyl impurity (PDHM impurity). These impurities were formed due to the usage of palladium catalyst during the pre-final reaction between 1 and 2. T

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2

Prajapati, Pintu B., Navneet Wankhed, and Priti J. Mehta. "A Review on Multi Approaches for Impurity Isolation and its Characterization." Journal of Drug Delivery and Therapeutics 9, no. 4-A (2019): 793–802. http://dx.doi.org/10.22270/jddt.v9i4-a.3627.

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International Conference on Harmonization (ICH) has formulated different guideline regarding the control of impurities. In this review, the impurity sources, classification, isolation, detection and characterization methods are described. The some impurities are unavoidable and will be present in trace amounts hence ICH guidelines frame the different policies and establish the specification limits, isolation and characterization is necessary for evaluation and control of impurities. The other regulatory bodies and drug development authorities look up to these guidelines for launching a quality

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3

Krishna, Singamsetty Radha, Mandava Venkata Naga Brahmeshwar Rao, Tirmalaraju Satyanaryana Raju, Vurimidi Himabindu, and Ghanta Mahesh Reddy. "Isolation, Synthesis and Characterization of Rosiglitazone Maleate Impurities." E-Journal of Chemistry 5, no. 3 (2008): 562–66. http://dx.doi.org/10.1155/2008/308724.

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Three unknown impurities in rosiglitazone maleate 1 bulk drug at level below 0.1% (ranging from 0.05 to 0.1%) were detected by simple reverse phase high performance liquid chromatography. These impurities were preliminarily identified with LC-MS and characterized by the mass number of the impurities. Different experiments were conducted and finally synthesized and characterized the unknown impurities.

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4

LAZĂR, LILIANA, (BĂLUȘESCU) GEORGIANA MARDARE, and DUMITRU COMAN. "Qualitative And Quantitative Analysis of Impurities in Chlorocholine Chloride: A Review." Buletinul Institutului Politehnic din Iași, Secția Chimie și Inginerie Chimică 70, no. 2 (2024): 77–91. https://doi.org/10.5281/zenodo.13308330.

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This study provides an overview of impurities in an active substance / active ingredient and selective analytical methods of impurities for their identification in chlorocholine chloride with applications and literature references. Moreover, its reviews the importance to understanding what determinates an impurity and identification of potential sources of this impurity is discussed. The analytes include 1,2-dichloroethane and trimethylamine which are relevant impurities acceptable by Food and Agriculture Organization of the United Nations and World Health Organization. After a concise resume

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5

Sharma, Yogesh Kumar, Dau Dayal Agarwal, Sudesh Bhure, Sanjay Singh Rathore, Chakravir Rawat, and Rajendranath Mukharjee. "Synthesis, Isolation and Characterization of Process-Related Impurities in Oseltamivir Phosphate." E-Journal of Chemistry 9, no. 1 (2012): 113–20. http://dx.doi.org/10.1155/2012/327351.

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Three known impurities in oseltamivir phosphate bulk drug at level 0.1% (ranging from 0.05-0.1%) were detected by gradient reverse phase high performance liquid chromatography. These impurities were preliminarily identified by the mass number of the impurities. Different experiments were conducted and finally the known impurities were synthesized and characterized.

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6

Sethi, Madhuresh Kumar, Vijendra Singh Rawat, Jayaprakash Thirunavukarasu, Rajakrishna Yerramalla, and Anish Kumar. "Synthesis and Characterization of Tolvaptan Impurities." Advances in Chemistry 2014 (July 10, 2014): 1–13. http://dx.doi.org/10.1155/2014/471950.

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Twenty-six possible as well as observed impurities during the preparation of Tolvaptan have been identified, prepared, and characterized by HPLC (high performance liquid chromatography), NMR (nuclear magnetic resonance), and mass spectra. Control of these impurities, formed during various stages of Tolvaptan preparation, has been mentioned in this paper.

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7

Srinivasachary, Katuroju, Chennuri Rajesh, Shashikant Tiwari, et al. "Synthesis and Characterization of Potential Impurities of Eltrombopag Olamine." Asian Journal of Chemistry 33, no. 1 (2020): 97–102. http://dx.doi.org/10.14233/ajchem.2021.22951.

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This work reports the feasibility of recently developed industrial viable process for eltrombopag olamine starting from 2-bromo-6-nitro phenol and reports the identification of four potential impurities related to eltrombopag olamine, namely eltrombopag olamine ester (1), 2-aminophenol analogue of eltrombopag (2), 3,3′-(2-amino-3-oxo-3H-phenoxazine-4,6-diyl dibenzoic acid (3), 2′-hydroxy[1,1- biphenyl]-3-carboxylic acid (4). These impurities are the crucial components in determining the quality of the drug substance, eltrombopag olamine during its manufacturing. These impurities have impact on

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8

Venkanna, G., G. Madhusudhan, K. Mukkanti, A. Sankar, Y. Sampath Kumar, and G. Venakata Narayana. "Synthesis and Characterization of Process-Related Impurities of Antihypertensive Drug Olmesartan Medoxomil." Journal of Chemistry 2013 (2013): 1–8. http://dx.doi.org/10.1155/2013/516459.

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Olmesartan medoxomil(1)is the latest angiotensin receptor antagonist approved by the FDA for the treatment of hypertension. During the process development of olmesartan medoxomil, three process-related impurities were observed along with the final API. These impurities were identified as isopropyl olmesartan (12), dimedoxomil olmesartan (19), dibiphenyl olmesartan (17). The present work describes the synthesis and characterization of all these three impurities.

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9

Cockayne, Eric. "Characterization of Impurities in Bilayer Graphene." ECS Transactions 28, no. 5 (2019): 87–94. http://dx.doi.org/10.1149/1.3367939.

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10

Beni, Szabolcs, John F. K. Limtiaco, and Cynthia K. Larive. "Analysis and characterization of heparin impurities." Analytical and Bioanalytical Chemistry 399, no. 2 (2010): 527–39. http://dx.doi.org/10.1007/s00216-010-4121-x.

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11

Sati, Bhawana, Hemlata Sati, Sarla Saklani, Prakash Chandra Bhatt, and Ravinesh Mishra. "Synthesis of the impurities during the manufacture of bulk drug midazolam and separation of these impurities by HPLC." Acta Pharmaceutica 63, no. 3 (2013): 385–96. http://dx.doi.org/10.2478/acph-2013-0025.

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Abstract During the manufacture of bulk drug midazolam various impurities arised that can be the related products or degradation products. Structures of eight impurities that can arise during the manufacture of bulk drug midazolam were proposed. In the present work, synthesis of these impurities and their characterization by different spectroscopic techniques have been done. HPLC method was developed for the separation of impurities from the bulk drug. The developed method separates midazolam from its eight impurities/degradation products within a run time of 45 min.

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12

Sharma, Yogesh Kumar, Dau Dayal Agarwal, Sudesh Bhure, Rajendra Nath Mukharjee, Pramod Kumar Sahu, and Santosh Bhardwaj. "Synthesis, Isolation and Characterization of Process-Related Impurities in Salbutamol Sulphate." E-Journal of Chemistry 8, no. 4 (2011): 1720–27. http://dx.doi.org/10.1155/2011/230231.

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Three known and one unknown impurities in salbutamol sulphate bulk drug at level 0.1% (ranging from 0.05-0.1%) were detected by gradient reverse phase high performance liquid chromatography. These impurities were preliminarily identified by the mass number of the impurities. Different experiments were conducted and finally synthesized and characterized the known and unknown imputities.

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13

Dai, Zuocai, Sha Zhou, Zhiliang Huang, and Hao Li. "Nanoscale Characterization and Impurities of Fused Silica Optical Surfaces." Advances in Materials Science and Engineering 2022 (July 16, 2022): 1–8. http://dx.doi.org/10.1155/2022/8308746.

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Fused silica is produced by melting high-purity silica and then rapidly cooling it. It has good physical and chemical properties, which also make it the raw material for most components in the optical industry, and is widely used in optical fiber communications, semiconductors, and aerospace. The content of SiO2 in fused silica is as high as 99.995% or more, but some impurities will still be generated during production and processing. The impurity elements of its optical curved surface can induce damage to the fused silica and adversely affect its performance, thereby affecting the performance

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14

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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15

Yasin, Sahl. "Ionic Liquids Nitrogen-Based, Preparation, Characterization, and Application." Pharmaceutics and Pharmacology Research 5, no. 6 (2022): 01–05. http://dx.doi.org/10.31579/2693-7247/083.

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Nowadays Ionic Liquids (ILs) salts becomes a major class of attention due to their numerous industrial applications in various fields such as softest solvents, catalysts, batteries, wastewater treatment…etc. In this review, we highlight and present ionic liquid nitrogen-based in both aliphatic and aromatic compounds. Aliphatic based nitrogen ionic liquids are prepared from different sources like trimethylamine, diethylamine, triethylamine, -tripropylamine, iso-propylamine, n-tributylamine, and n-butylamine. However, to prepare aromatic based nitrogen ionic liquids, it’s better to use amidazole

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16

Feng, Wei-Dong, Song-Ming Zhuo, and Fu-Li Zhang. "Synthesis and characterization of new impurities in obeticholic acid." Journal of Chemical Research 43, no. 11-12 (2019): 522–30. http://dx.doi.org/10.1177/1747519819875858.

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Novel and efficient synthetic strategies are developed for the first synthesis of two new impurities found in obeticholic acid. The synthetic routes to the impurities are designed without column purification using 4-nitrobenzoyl chloride as a selective protecting group. The impurities, which are obtained in good yields and high purity, are identified and characterized using high-resolution mass spectrometry, Fourier transform infrared, one-dimensional nuclear magnetic resonance (1H, 13C, distortionless enhancement by polarization transfer), and two-dimensional nuclear magnetic resonance (Corre

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17

Sunil Kumar, I. V., G. S. R. Anjaneyulu, and V. Hima Bindu. "Identification and synthesis of impurities formed during sertindole preparation." Beilstein Journal of Organic Chemistry 7 (January 7, 2011): 29–33. http://dx.doi.org/10.3762/bjoc.7.5.

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Sertindole (1), an atypical anti-psychotic drug is used for the treatment of schizophrenia. During the laboratory optimization and later during its bulk synthesis the formation of various impurities was observed. The impurities formed were monitored and their structures were tentatively assigned on the basis of their fragmentation patterns in LC-MS. Most of the impurities were synthesized and their assigned constitutions confirmed by co-injection in HPLC. We describe herein the formation, synthesis and characterization of these impurities. Our study will be of immense help to others to obtain

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18

Xiong, Kaihe, Xingling Ma, Na Cao, et al. "Identification, characterization and HPLC quantification of impurities in apremilast." Analytical Methods 8, no. 8 (2016): 1889–97. http://dx.doi.org/10.1039/c5ay01759a.

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A new compound Imp-F was obtained and the structures were elucidated by using spectral data (NMR, MS, and IR); the potential process-related impurities were speculated in the apremilast drug; LC conditions were optimized and an effective HPLC method for the quantitative determination of the potential process-related impurities in apremilast was developed.

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19

Reddy Gopa, Sudheer Kumar, Pradeep Kumar Brahman, and Usenireddy Mallu. "Synthesis and Structural Characterization of Process Related Impurities of Mirabegron: A Beta-3 Adrenergic Agonist Drug." Asian Journal of Chemistry 34, no. 11 (2022): 3026–32. http://dx.doi.org/10.14233/ajchem.2022.23986.

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In the synthesis of active pharmaceutical ingredient and the development of pharmaceutical products, the impurities profiling plays a significant role. The control of impurities is essential for producing the quality, safe and efficient drug products for therapeutic use. Few works reported for the synthesis of potential impurities and further characterized to support the synthesis route and purity of the synthesized compound. Hence in present study, five impurities of mirabegron such as impurity 3, 4, 6, 8 and 9 were synthesized and structural characterization was carried using NMR, IR and mas

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20

Reddy, T. Purendar, Nageshwar Dussa, Srinivas Mamidi, Mahesh Panasa, Ramadas Chavakula, and M. Padma. "Identification, Isolation and Origin of Potential Dimer Impurities of Dichlorphenamide: A Carbonic Anhydrase Inhibitor Drug (Antiglaucoma)." Asian Journal of Chemistry 33, no. 6 (2021): 1249–52. http://dx.doi.org/10.14233/ajchem.2021.23166.

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Present work describes the identification, isolation and characterization of two new process related dimeric impurities of dichlorphenamide (1). During the synthesis of dichlorphenamide, the formation of two new dimeric impurities namely 2,3-dichloro-5-(3,4-dichloro-5-sulfamoyl-phenyl)sulfonylbenzenesulfonamide (2) (1,1Œ-dichlorphenamide dimer) and 2,3-dichloro-5-(2,3-dichloro-5-sulfamoylphenyl) sulfonyl-benzenesulfonamide (3) (1,3Œ-dichlorphenamide dimer) was observed. In addition, origin and the strategies adapted to control these potential dimer impurities were also described. These impur

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21

Vasu Dev, R., J. Moses Babu, K. Vyas, et al. "Isolation and characterization of impurities in docetaxel." Journal of Pharmaceutical and Biomedical Analysis 40, no. 3 (2006): 614–22. http://dx.doi.org/10.1016/j.jpba.2005.10.037.

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22

Guo, Fujiang, Huijin Feng, Youfu Wang, Chune Zhang, and Yuanchao Li. "Characterization of related impurities in megestrol acetate." Journal of Pharmaceutical and Biomedical Analysis 41, no. 4 (2006): 1418–22. http://dx.doi.org/10.1016/j.jpba.2006.02.048.

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23

Filip, Katarzyna, Krzysztof Bańkowski, Katarzyna Sidoryk, et al. "Physicochemical characterization of ezetimibe and its impurities." Journal of Molecular Structure 991, no. 1-3 (2011): 162–70. http://dx.doi.org/10.1016/j.molstruc.2011.02.020.

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24

Ferraboschi, Patrizia, Diego Colombo, Maria De Mieri, and Paride Grisenti. "Evaluation, synthesis and characterization of tacrolimus impurities." Journal of Antibiotics 65, no. 7 (2012): 349–54. http://dx.doi.org/10.1038/ja.2012.28.

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25

Li, Wei, Fuzhong Wu, Huixin Jin, and Shuie Li. "Analysis of Fe and Mn impurities in Chinese sponge titanium enterprise using an input-output model." Metallurgical Research & Technology 117, no. 4 (2020): 401. http://dx.doi.org/10.1051/metal/2020031.

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The impurity content is an important index reflecting the quality of sponge titanium, especially Fe and Mn impurities. However, at present, only qualitative research has been conducted on the input of impurities, and no quantitative research has been conducted on the input and output of impurities. Therefore, based on the input-output model, this study analyzes the input and output of typical impurities in the magnesiothermic reduction-vacuum distillation process, product sorting process, and magnesium processing process, respectively. Quantitative characterization of the input and output of i

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26

Losic, Dusan, Farzaneh Farivar, and Pei Lay Yap. "Refining and Validating Thermogravimetric Analysis (TGA) for Robust Characterization and Quality Assurance of Graphene-Related Two-Dimensional Materials (GR2Ms)." C 10, no. 2 (2024): 30. http://dx.doi.org/10.3390/c10020030.

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Graphene-related two-dimensional materials available on the global market are manufactured using various production methods, with significant variations in properties and qualities causing serious concerns for the emerging multi-billion graphene industry. To address the limitations of conventional characterization methods probing the properties of individual graphene particles which may overlook the presence of non-graphene carbon impurities at a large (bulk) scale, this paper presents the refining thermogravimetric analysis as a complementary method for the reliable chemical characterization

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27

Westwood, Glenn. "Nuclear Magnetic Resonance Spectroscopy of Trace Organic Impurities Extracted from a Corrosion Inhibitor and a Semiaqueous Residue Remover." Solid State Phenomena 219 (September 2014): 284–87. http://dx.doi.org/10.4028/www.scientific.net/ssp.219.284.

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Within the next ten years, advanced semiconductor manufacturing will move into the sub-10 nm regime [1]. At these dimensions, there is concern that molecular scale impurities (≤ 1 nm diameter) within cleaning chemistries will have an increasing impact on wafer cleanliness, device yield, and performance. Considering that these impurities may be on the same size scale as some of the active ingredients, this will raise significant challenges for solution developers in terms of impurity identification and prevention. Herein, we will describe our efforts to better understand the impurities within a

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28

Sandström, Karin, Markus Carlborg, Matias Eriksson, and Markus Broström. "Characterization of Limestone Surface Impurities and Resulting Quicklime Quality." Minerals 14, no. 6 (2024): 608. http://dx.doi.org/10.3390/min14060608.

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Quicklime, rich in CaO(s), is generated by calcining limestone at high temperatures. Parallel-flow regenerative lime kilns are the most energy-effective industrial method available today. To prevent major disruptions in such kilns, a high raw material quality is necessary. Under some conditions, impurity-enriched material may adhere to limestone pebbles and enter the kiln. In this study, limestone and corresponding quicklime were analyzed to evaluate the extent and composition of surface impurities and assess the effect on quicklime product quality, here defined as free CaO. This was performed

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29

Pandurang, Panchabhai Prasad, and Kailas Narayan Sonune. "An Improved Synthesis of Teriflunomide and Identification, Synthesis and Characterization of Its Critical Process Impurities." Journal of Pharmaceutical Research International 36, no. 7 (2024): 205–19. http://dx.doi.org/10.9734/jpri/2024/v36i77551.

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Teriflunomide has an impeccable drug used to treat multiple sclerosis. Ample of literature is available for its synthesis, however, it does not reveals the potential impurities formation during synthesis, The chief intent of the article is to highlight the key impurities formation in Teriflunomide synthesis that yet to have to be documented in the literature and are not mentioned in any monograph. It also provides an overview of the process flow for the formation of new contaminants and their fate in the carryover study. The generation of corresponding impurities from impurity-I, i.e. ((Z)-4-A

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30

Singaram, Sathiyanarayanan, Venkatesan Chidambaram Subramanian, Senthamaraikannan Kabilan, and Dandu Bhaskara Suresh Raju. "Identification, Synthesis, Characterization and Quality Control Strategy of New Process-Related Impurities in Fosphenytoin Sodium." Asian Journal of Chemistry 32, no. 8 (2020): 1881–85. http://dx.doi.org/10.14233/ajchem.2020.22669.

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Fosphenytoin sodium is a water dissolvable phenytoin prodrug that is directed intravenously to convey phenytoin, conceivably more securely than intravenous phenytoin. It is most ordinarily utilized in the intense treatment of convulsive status epileptics. The examination of the procedure-related contaminants will not help exclusively to advance the process parameters yet additionally to create sensible analytical methods and set the quality standard for a quality control system in pharmaceutical manufacturing. During the production of fosphenytoin sodium, all the process-related impurities are

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31

Zou, Liang, Lili Sun, Hui Zhang, Wenkai Hui, Qiaogen Zou, and Zheying Zhu. "Identification, Characterization, and Quantification of Impurities of Safinamide Mesilate: Process-Related Impurities and Degradation Products." Journal of AOAC INTERNATIONAL 100, no. 4 (2017): 1029–37. http://dx.doi.org/10.5740/jaoacint.16-0218.

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Abstract The characterization of process-related impurities and degradation products of safinamide mesilate (SAFM) in bulk drug and a stability-indicating HPLC method for the separation and quantification of all the impurities were investigated. Four process-related impurities (Imp-B, Imp-C, Imp-D, and Imp-E) were found in the SAFM bulk drug. Five degradation products (Imp-A, Imp-C, Imp-D, Imp-E, and Imp-F) were observed in SAFM under oxidative conditions. Imp-C, Imp-D, and Imp-E were also degradation products and process-related impurities. Remarkably, one new compound, identified as (S)-2-[4

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32

Prasad Ketha, Naga Venkata Durga, and Deepti Kolli. "USING PREPARATIVE CHROMATOGRAPHY AND NMR/LCMS/FT-IR, ISOLATION, IDENTIFICATION, AND CHARACTERIZATION OF POSACONAZOLE OXIDATIVE DEGRADATION IMPURITIES." Rasayan Journal of Chemistry 15, no. 01 (2022): 619–27. http://dx.doi.org/10.31788/rjc.2022.1516707.

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Posaconazole is a pharmacological ingredient that is used to treat fungal infections. It comes in the form of delayedrelease tablets. During the forced degradation studies of Tablets, two unknown oxidative degradation impurities were discovered. The impurities were made from Posaconazole using meta-Chloroperoxybenzoic acid as an oxidant in the degradation process. Preparative chromatography was used to separate impurities, and spectroscopic techniques such as IR, NMR, and MS were used to deduce the structures. For the measurement of the total of six associated impurities of Posaconazole in Del

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33

Soni, Zinal, Santosh Patil, Santhosh Koppula, and Poonam Koppula. "Ultrasound-assisted efficient synthesis of 3-[4-(2-methoxyethyl) phenoxy] propane -1,2 -diol (Metoprolol EP impurity D)." Organic Communications 14, no. 1 (2021): 92–96. http://dx.doi.org/10.25135/acg.oc.98.20.10.1844.

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Safety of the drug molecule is dependent on the various impurities formed during chemical transformation which may cause drug product instability, decreased product performance, loss in potency, and/or formation of potentially genotoxic impurities. Therefore, it is essential to identify and quantify the impurities generated during the drug development stage. Herein, we describe the synthesis and characterization of Impurity D of Metoprolol, 3-[4-(2-methoxyethyl)phenoxy]propane-1,2-diol (1), reported in European Pharmacopeia. The synthesis of impurity D has been accomplished in two steps; start

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34

Callahan, Daniel, and G. Thomas. "CBED analysis of impurity distributions in AlN." Proceedings, annual meeting, Electron Microscopy Society of America 48, no. 4 (1990): 214–15. http://dx.doi.org/10.1017/s0424820100174205.

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Oxygen impurities may significantly influence the properties of nitride ceramics with a strong dependence on the microstructural distribution of the impurity. For example, amorphous oxygen-rich grain boundary phases are well-known to cause high-temperature mechanical strength degradation in silicon nitride whereas solutionized oxygen is known to decrease the thermal conductivity of aluminum nitride. Microanalytical characterization of these impurities by spectral methods in the AEM is complicated by reactions which form oxygen-rich surface phases not representative of the bulk material. Furthe

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35

Silva Elipe, Maria Victoria, Zhixin Jessica Tan, Michael Ronk, and Tracy Bostick. "A Multidisciplinary Investigation to Determine the Structure and Source of Dimeric Impurities in AMG 517 Drug Substance." International Journal of Analytical Chemistry 2009 (2009): 1–12. http://dx.doi.org/10.1155/2009/768743.

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In the initial scale-up batches of the experimental drug substance AMG 517, a pair of unexpected impurities was observed by HPLC. Analysis of data from initial LC-MS experiments indicated the presence of two dimer-like molecules. One impurity had an additional sulfur atom incorporated into its structure relative to the other impurity. Isolation of the impurities was performed, and further structural elucidation experiments were conducted with high-resolution LC-MS and 2D NMR. The dimeric structures were confirmed, with one of the impurities having an unexpected C-S-C linkage. Based on the synt

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36

Sathiyanarayanan, Singaram, Chidambaram Subramanian Venkatesan, and Senthamaraikannan Kabilan. "Synthesis and Characterization of Potential and Degraded Impurities of Regadenoson." Current Pharmaceutical Analysis 16, no. 8 (2020): 1130–39. http://dx.doi.org/10.2174/1573412915666190819095255.

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Background: Regadenoson is an A2A adenosine receptor agonist that is a coronary vasodilator and commonly used as a pharmacologic cardiac stressing agents. Methods: HPLC method was used for the analysis of related substances. The degraded impurities during the process were isolated and characterized by IR, Mass and NMR spectral analysis. Results: Forced degradation study of regadenoson under conditions of hydrolysis (neutral, acidic and alkaline) and oxidations suggested in the ICH Q1A(R2) was accomplished. The drug showed significant degradation under all the above conditions. On the whole, fi

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37

Pritesh Kardile, Dattatray Chadar, Gorakshanath Shinde, Dilip R. Birar, and Prashant A. Patil. "Synthesis and Characterization of Chiral Impurities of Edoxaban Tosylate Monohydrate, Used As an Anticoagulant Drug." International Research Journal on Advanced Engineering and Management (IRJAEM) 3, no. 03 (2025): 569–75. https://doi.org/10.47392/irjaem.2025.0091.

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The present invention relates to identified and prepared chiral impurities in Edoxaban Tosylate monohydrate (1). This work describes the synthesis of chiral impurities of each intermediate, including KSM and its drug substance and their characterization by spectral data (IR, MS,1H-NMR, and 13C-NMR). During the process development of Edoxaban Tosylate monohydrate (1) several unknown peaks were detected by high performance liquid column chromatography (HPLC) using chiral column. Edoxaban Tosylate monohydrate is the Tosylate salt form of edoxaban with binding one water molecule, an orally active

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38

Mount, Dwight L., James W. Miles, and Frederick C. Churchill. "Liquid Chromatographic and Spectroscopic Characterization of Pentamidine Isethionate and Impurities in Bulk Drug and Injectables." Journal of AOAC INTERNATIONAL 69, no. 4 (1986): 624–29. http://dx.doi.org/10.1093/jaoac/69.4.624.

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Abstract A liquid chromatographic (LC) method is described for evaluating purity of pentamidine isethionate (PI), a life-saving drug used in the treatment of Pneumocystis carinii pneumonia, which is a leading cause of death in persons with acquired immunodeficiency syndrome (AIDS). Six potential impurity compounds were synthesized to test the selectivity of the chromatographic system and to permit quantitation of impurities in various lots of PI products. The drug and impurities were separated with gradient elution on a cyano-bonded LC column. The analytic system provided information on the id

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Maruthi R, Chandan R S, and Anand Kumar Tengli. "Characterization of Impurities in Acarbose Hydrate by using LCMS/MS and NMR." International Journal of Research in Pharmaceutical Sciences 11, no. 4 (2020): 8124–29. http://dx.doi.org/10.26452/ijrps.v11i4.4885.

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An accurate and lively LC-MS/MS and NMR analytical methods have been developed for the recognition and characterization of key impurities in Acarbose. Acarbose is a diabetic medication used to treat Diabetes mellitus Type II and prediabetes in certain countries. Three unknown impurities were detected in Acarbose hydrate bulk drug substance using RP-HPLC method at RT 17.65 min, 18.4 min and 25.85 min. Such impurities have been separated by HPLC and are further characterized by the use of techniques LC-MS / MS and NMR. The C18 reverse phase column and Methanol and Ammonium Type analysis (80:20)

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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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Zhang, Chaowei, Chengqun Han, Lili Sun, Jinlong Yu, and Qiaogen Zou. "Identification, Characterization and HPLC Quantification of Process-Related Impurities in Bepotastine Besilate Bulk Drug." Drug Research 70, no. 01 (2019): 12–22. http://dx.doi.org/10.1055/a-0831-2401.

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AbstractBepotastine besilate (here after referred to as BTST), chemically known as ({d(S)4[4[(4chlorophenyl) (2pyridyl) methoxy] piperidino} butyric acid monobenzene sulphonate), is a second-generation antihistamine drug. To the best of our knowledge, no studies concerning the isolation or identification of process-related impurities have been reported so far. The current study reports the development and validation of a stability-indicating RP-HPLC method for the separation and identification of 5 potential impurities in bepotastine besilate. In this experiment, the structures of 3 process-re

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Saravanan, S., and A. Taminum Ansari. "LC-MS/MS STUDY OF THE TRACE LEVEL IMPURITIES OF IRBESARTAN AN ANGIOTENSIN II RECEPTOR ANTAGONIST MOLECULE TO ITS ORIGIN THROUGH nMS2 TECHNIQUE." International Journal of Pharmacy and Pharmaceutical Sciences 11, no. 1 (2019): 38. http://dx.doi.org/10.22159/2019v11i1.29037.

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Objective: The mass characterization of five trace level related impurities of Irbesartan was performed through the “nMS2” technique of triple quadrupole mass spectrometer and also to Correlated to the impurity origin.Methods: A simple & effective patented process was applied to get the impurity profile, and mass characterization was performed through the “nMS2” technique of triple quadrupole mass spectrometer analyser.Results: The simple production scan in differential collision energies is coined as “nMS2” technique of the triple quadrupole analyzer. The molecular ion fragmentation occur

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CHANG, SHIN S. "Analysis and Characterization of Some Cane Sugar Impurities." Journal of Food Science 50, no. 3 (1985): 823–24. http://dx.doi.org/10.1111/j.1365-2621.1985.tb13804.x.

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Treberspurg, Wolfgang, Thomas Bergauer, Marko Dragicevic, Manfred Krammer, and Manfred Valentan. "Characterization of irradiation induced deep and shallow impurities." Nuclear Instruments and Methods in Physics Research Section A: Accelerators, Spectrometers, Detectors and Associated Equipment 732 (December 2013): 173–77. http://dx.doi.org/10.1016/j.nima.2013.08.025.

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Goverdhan, Gilla, Anumula Raghupathi Reddy, Kurella Srinivas, Vurimidi Himabindu, and Ghanta Mahesh Reddy. "Identification, characterization and synthesis of impurities of zafirlukast." Journal of Pharmaceutical and Biomedical Analysis 49, no. 4 (2009): 895–900. http://dx.doi.org/10.1016/j.jpba.2009.01.023.

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Kumar, Y. Ravindra, V. V. N. K. V. Prasad Raju, R. Rajesh Kumar, et al. "Structural identification and characterization of impurities in moxifloxacin." Journal of Pharmaceutical and Biomedical Analysis 34, no. 5 (2004): 1125–29. http://dx.doi.org/10.1016/j.jpba.2003.11.012.

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Krishna Reddy, K. V. S. R., J. Moses Babu, P. Anil Kumar, et al. "Identification and characterization of potential impurities of donepezil." Journal of Pharmaceutical and Biomedical Analysis 35, no. 5 (2004): 1047–58. http://dx.doi.org/10.1016/j.jpba.2004.03.022.

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Weldon, Stephen T., Susan I. Williams-Van Alstyne, A. Jay Gandolfi, and Casey D. Blitt. "Production and Characterization of Impurities in Isoflurane Vaporizers." Anesthesia & Analgesia 64, no. 6 (1985): 634???639. http://dx.doi.org/10.1213/00000539-198506000-00012.

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Occelli, M. L., F. E. Huggins, J. M. Dominguez, J. M. Stencel, and S. A. C. Gould. "Characterization of iron impurities in pillared rectorite catalysts." Microporous Materials 4, no. 4 (1995): 291–300. http://dx.doi.org/10.1016/0927-6513(95)00015-2.

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Moreno, Miguel. "Microscopic characterization of impurities in insulators through EPR." Journal of Physics and Chemistry of Solids 51, no. 7 (1990): 835–59. http://dx.doi.org/10.1016/0022-3697(90)90152-6.

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