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Relevant bibliographies by topics / Chromatographic impurity

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Academic literature on the topic 'Chromatographic impurity'

Author: Grafiati

Published: 4 June 2025

Last updated: 1 August 2025

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Journal articles on the topic "Chromatographic impurity"

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Nakov, Natalija, Rumenka Petkovska, Liljana Ugrinova, Suzana Trajkovic-Jolevska, and Aneta Dimitrovska. "Determination of Rocuronium bromide by hydrophilic interaction liquid chromatography (HILIC)." Macedonian Pharmaceutical Bulletin 57 (2001): 17–24. http://dx.doi.org/10.33320/maced.pharm.bull.2011.57.002.

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A new method involving hydrophilic interaction liquid chromatography (HILIC) has been developed for determination of rocuronium bromide in presents of its main impurities (impurity A and impurity C), which are also its main degradation products, in solution for injection. The influence of the critical chromatographic parameters such as content of acetonitrile in the mobile phase, ionic strength and pH value of the buffer used in the mobile phase were investigated using the Design of experiments approach (DoE). The mechanism of retention of rocuronium bromide on bare silica column was also inve

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Mule, Kishorkumar L., and Dnyandeo B. Pathare. "DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ISOSULFAN BLUE BY LIQUID CHROMATOGRAPHY." International Journal of Applied Pharmaceutics 9, no. 2 (2017): 42. http://dx.doi.org/10.22159/ijap.2017v9i2.16904.

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Objective: To develop and validate new, simple and rapid analytical method for determination of related impurities in isosulfan blue drug substances by the liquid chromatographic method as per ICH guidelines.Methods: The chromatographic separation obtained between drug substance i.e. isosulfan blue and its related impurities (Impurity-A, Impurity-B and Impurity-C) on C18 (100 x 2.00 mm) 1.9µ UPLC column using a mobile phase system containing 0.1 % perchloric acid in water (Mobile phase A) and 0.1 % perchloric acid in mixture of 30 volumes of water and 70 volumes of acetonitrile (Mobile Phase B

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Bor Fuh, C., and M. L. Wu. "Impurity analysis of methamidophos with chromatographic methods." Analytica Chimica Acta 395, no. 3 (1999): 257–63. http://dx.doi.org/10.1016/s0003-2670(99)00330-x.

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Lawande, Appasaheb Bajirao. "SEPARATION AND DETERMINATION OF THE R-ISOMER OF KETOPROFEN IN A BULK DRUG SUBSTANCE BY NORMAL PHASE LIQUID CHROMATOGRAPHY." Asian Journal of Pharmaceutical and Clinical Research 10, no. 1 (2016): 302. http://dx.doi.org/10.22159/ajpcr.2017.v10i1.15318.

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ABSTRACTObjective: The objective is defined to develop and validate simple, rapid, precise, and accurate for separation and determination of R-isomer impurityof ketoprofen bulk drug material by the normal phase high-performance liquid chromatographic method as per the International Conference ofHarmonization Guideline (ICH) guidelines.Methods: The R-isomer and S-isomer were baseline resolved on a Chiralcel OJ-H, 150 mm × 4.6 mm, and 5 µm stationary phase column. Mobile phasesystem containing n-hexane:isopropyl alcohol:glacial acetic acid (50:50:0.1 v/v.). The detector wavelength has been selec

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S., Mohan, Srinivasarao N., and Lakshmi K. "Development and Validation of a Stability indicating Related Substances of Baricitinib by RP-HPLC and its Degradation." International Journal of Management and Humanities (IJMH) 4, no. 2 (2019): 4–9. https://doi.org/10.35940/ijmh.A0369.104219.

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Reverse phase high performance liquid chromatography method, for estimation of related substances or chromatographic impurities of Barcitinib was developed and validated. Baricitinib was developed by separating its degradation products on a X-Terra RP18 (150x4.6mm, 5.0 µm) column using 0.1% Tri ethyl amine in water adjusted pH-2.5 with OPA and Acetonitrile in simple gradient at a flow rate 1.0 ml/min. The column effluents were monitored by a photodiode array detector set at 224nm. The method was validated in terms of specificity, linearity, accuracy, precision, detection limit, quantific

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Najana, Sanni Babu, and Bala Murali Krishna Khandapu. "Quantification of Impurity-E in Voriconazole Powder for Solution for Infusion (200 mg/vial) by using High Performance Liquid Chromatography." Caribbean Journal of Science and Technology 10, no. 02 (2022): 01–09. http://dx.doi.org/10.55434/cbi.2022.20101.

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A novel stability indicating liquid chromatographic method was developed and validated for the quantification of impurity-E((±)-βCamphorsulfonic acid, (±)-Camphor-10-sulfonic acid)in Voriconazole powder for solution for infusion formulation. The separation was achieved on Novapak (150 x 3.9 mm, 4 μm) column using a movable segment consisting of pH 5.0 acetate buffer and acetonitrile gradient elution mode, at a flow rate of 1.0 ml/min. Column oven maintained at 35°C, inoculation quantity 50 µl, sample cooler temperature 5 °C and detection wavelength 286 nm. Chromatographic resolution between im

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Raja, K. Durga, V. Saradhi Venkata Ramana, K. Raghu Babu, et al. "Development and Validation of UPLC-ESI-MS/MS Technique for the Determination of 2-Isopropyl-4-(chloromethyl)thiazole in Ritonavir." Asian Journal of Chemistry 32, no. 7 (2020): 1733–40. http://dx.doi.org/10.14233/ajchem.2020.22677.

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The objective of this work was to develop and validate a rapid, highly sensitive ultra performance liquid chromatography-tandem mass spectrometry (UPLC-ESI-MS/MS) method for the quantification of 2-isopropyl-4-(chloromethyl)thiazole in ritonavir. Chromatographic conditions of this impurity were achieved on an AQUITY UPLC column HSS (high strength silica) T3 column (100 mm long, 2.1 mm internal diameter, 1.8 μm diameter) using a gradient elution with 0.1% formic acid in water and methanol at a flow rate of 0.3 mL/min. LCMS/MS was operated under the multiple reaction mode (MRM) using electrospra

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Ronowicz, Joanna, Bogumiła Kupcewicz, Joanna Mydłowska, and Elżbieta Budzisz. "Impurity profile analysis of drug products containing acetylsalicylic acid: a chemometric approach." Open Chemistry 11, no. 7 (2013): 1091–100. http://dx.doi.org/10.2478/s11532-013-0243-2.

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AbstractIn this work attention is focused on impurity profile analysis in combination with infrared spectroscopy and chemometric methods. This approach is considered as an alternative to generally complex and time-consuming classic analytical techniques such as liquid chromatography. Various strategies for constructing descriptive models able to identify relations among drug impurity profiles hidden in multivariate chromatographic data sets are also presented and discussed. The hierarchical (cluster analysis) and non-hierarchical segmentation algorithms (k-means method) and principal component

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Boyd, Willard G. "Impurity Problems in Chromatographic Method Studies for Fenthion Formulations." Journal of AOAC INTERNATIONAL 68, no. 5 (1985): 925–29. http://dx.doi.org/10.1093/jaoac/68.5.925.

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Abstract Several gas chromatographic (GC) methods for analyzing fenthion were studied, and flame ionization detection, a glass column packed with SE-52 on Chromosorb GHP, and on-column injection were selected as parameters. No suitable internal standard was found because of coeluting, bias-producing impurities in fenthion. Several liquid chromatographic (LC) methods were also studied, and UV detection, a Zorbax ODS column, and a methanol-water-H3P04 mobile phase were finally selected as parameters. Dipentyl phthalate was selected as internal standard. After testing, this LC method was submitte

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Nawale, Rajesh, Shankar Pol, Prashant Puranik, Anwar Daud, and Vishal Rajkondawar. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DABIGATRAN ETEXILATE RELATED SUBSTANCE IN PHARMACEUTICAL DOSAGE FORM BY REVERSE‑PHASE – HIGH‑PERFORMANCE LIQUID CHROMATOGRAPHY." Asian Journal of Pharmaceutical and Clinical Research 11, no. 10 (2018): 357. http://dx.doi.org/10.22159/ajpcr.2018.v11i10.27043.

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Objective: The objective of the study was to develop and validate new, simple, and selective reverse-phase–high-performance liquid chromatography (RP-HPLC) method for the quantitative determination of Dabigatran Etexilate (DE) and its impurities in pharmaceutical dosage form as per the International Conference on Harmonization guidelines.Method: Chromatographic analysis was performed on Princeton SPHER-l00 C18 (250 × 4.6 mm, 5 μm) HPLC column, maintained at 50°C column temperatures, 6°C sample tray temperature, and detection monitored at 225 nm. The mobile phase consisted of acetonitrile:phosp

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Dissertations / Theses on the topic "Chromatographic impurity"

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Denk, Oliver Matthias. "Impurity studies of bulk drug substances by capillary electrophoresis and high performance liquid chromatography." Thesis, University of Strathclyde, 2000. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.248566.

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Eldridge, Stacie Liane. "Development of analytical methods for trace impurity analysis and structure determination of heparin/heparan sulfate-derived oligosaccharides." Diss., [Riverside, Calif.] : University of California, Riverside, 2009. http://proquest.umi.com/pqdweb?index=0&did=1899476621&SrchMode=2&sid=2&Fmt=2&VInst=PROD&VType=PQD&RQT=309&VName=PQD&TS=1269284173&clientId=48051.

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Thesis (Ph. D.)--University of California, Riverside, 2009.<br>Includes abstract. Available via ProQuest Digital Dissertations. Title from first page of PDF file (viewed March 10, 2010). Includes bibliographical references. Also issued in print.

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Wahl, Oliver. "Impurity Profiling of Challenging Active Pharmaceutical Ingredients without Chromophore." Doctoral thesis, 2016. https://nbn-resolving.org/urn:nbn:de:bvb:20-opus-137205.

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The impurity profiling of pharmaceutical ingredients can oppose many challenges. The best part of active pharmaceutical ingredients (APIs) and the related substances are detectable by UV detection, a very common detection principle. However, if an API lacks a suitable chromophore other means of detection are necessary. The corona charged aerosol detector (CAD) is a detector capable of detecting substances independent of their chemical structure. This “universal” detector has only one limitation: The analyte has to have a sufficiently low vapor pressure. Another important challenge that comes o

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Book chapters on the topic "Chromatographic impurity"

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Ilko, David, Robert C. Neugebauer, Sophie Brossard, Stefan Almeling, Michael Türck, and Ulrike Holzgrabe. "Impurity Control in Topiramate with High Performance Liquid Chromatography." In Charged Aerosol Detection for Liquid Chromatography and Related Separation Techniques. John Wiley & Sons, Inc., 2017. http://dx.doi.org/10.1002/9781119390725.ch11.

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Zeng, Kui, Michael T. Boyne, Tim K. Toby, and Connie Ruzicka. "Chapter 9. Impurity Characterization and Quantification by Liquid Chromatography–High-resolution Mass Spectrometry." In Peptide Therapeutics. Royal Society of Chemistry, 2019. http://dx.doi.org/10.1039/9781788016445-00313.

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Konarachapalle, Nagalakshmi. "Chromatographic Techniques." In Analytical Methods for Drug Development. THINKPLUS PHARMA PUBLICATIONS, 2025. https://doi.org/10.69613/j49f3p67.

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Chromatographic methods separate complex pharmaceutical mixtures based on differential interactions between components, mobile phases, and stationary phases. HPLC techniques utilize diverse separation mechanisms, stationary phases, mobile phase compositions, and detection systems for pharmaceutical assays, impurity profiling, and stability studies. Gas chromatography analyzes volatile compounds, residual solvents, and headspace samples with temperature programming, specialized columns, and various detection systems. Ion chromatography quantifies counterions, ionic impurities, and ionic formula

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Arji, Sravani Ratnam, Vyshnavi K, Prakash Nathaniel Kumar Sarella, and Vinny Therissa Mangam. "CHROMATOGRAPHIC TECHNIQUES FOR PHARMACEUTICAL ANALYSIS." In Futuristic Trends in Pharmacy & Nursing Volume 3 Book 19. Iterative International Publisher, Selfypage Developers Pvt Ltd, 2024. http://dx.doi.org/10.58532/v3bgpn19p2ch1.

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This chapter serves as a comprehensive review of various chromatographic techniques employed in pharmaceutical analysis. It delves into the principles, instrumentation, and factors influencing separation for essential chromatographic methods, including High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Thin Layer Chromatography (TLC), and other significant techniques like Size Exclusion Chromatography, Ion Exchange Chromatography, Supercritical Fluid Chromatography, and Chiral Chromatography. Emphasizing the importance of HPLC and GC, the chapter explores their extensive a

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Rajasekhar, K., Ch Gangu Naidu, Ch Naga Sesha Sai Pavan Kumar, K. Varaprasada Rao, and Y. Srinivasa Rao. "Development and Validation of A RP-HPLC Method for the Simultaneous Determination of Twenty Related Substances of Sulfamethoxazole and Trimethoprim in Injection Dosage Form." In Current Trends in Drug Discovery, Development and Delivery (CTD4-2022). Royal Society of Chemistry, 2023. http://dx.doi.org/10.1039/9781837671090-00246.

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A simple, robust and for the quantification of experimentally 20 related impurities of sulfamethoxazole (SM) and trimethoprim (TM) in liquid pharmaceutical dosage form, a novel RP-HPLC method was developed. Utilizing gradient elution on a Kromasil 100-5-C18; 5.0 m, (4.0x250) mm, column, chromatographic separation was accomplished. Solvent A (solution of 0.08% orthophosphoric acid in water) and Solvent B (mixture of acetonitrile and methanol, 80:20 v/v), given at a flow rate of 0.8 ml/min, respectively, make up the mobile phase. Using a photodiode array (PDA) detector, the analytes were identif

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"Real-time Analysis." In Green Chemistry: Principles and Case Studies. The Royal Society of Chemistry, 2019. http://dx.doi.org/10.1039/bk9781788017985-00321.

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Real-time analysis may be the most underappreciated Principle of Green Chemistry, yet its importance cannot be ignored. Every chemical process requires analysis, whether before, during, or after. Continuous-flow processes offer opportunities for real-time analysis just about anytime and anywhere during the process. Performing analysis in real-time requires consideration of what parameters are appropriate to monitor. Physical parameters include temperature, pressure, heat, pH, or light. Chemical parameters include reactants, intermediates, products, or by-products. Soltex developed a continuous

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Subash, Paranthaman, K. K. Senthil Kumar, Kareti Srinivasa Rao, and Sulekha Khute. "Advanced Chromatography Analytical Methods for the Isolation and Identification of Natural Drug Molecules." In Advances in Analytical and Coordination Chemistry - Applications and Innovations [Working Title]. IntechOpen, 2025. https://doi.org/10.5772/intechopen.1007501.

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The creation of stability-indicating analytical methods, phytoconstituent identification, and validation for content and impurity estimation in pharmaceutical drug products and drug substances using high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), liquid chromatography-mass spectrometry (LC-MS), gas chromatography-mass spectrometry (GC-MS), and supercritical fluid chromatography (SFC) employing contemporary analytical techniques are the primary topics of this chapter. The intricacy and diversity of herbal components provide the most analytical hurd

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Mercado, Roberto, Silvia Lagos, and Ethel Velásquez. "Radiochemical Purity and Identity in Radiopharmaceuticals: Design and Improvement of Quality Control Methods by HPLC." In Advances in Dosimetry and New Trends in Radiopharmaceuticals. IntechOpen, 2023. http://dx.doi.org/10.5772/intechopen.112355.

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The radiopharmaceutical supply chain involves rigorous quality control tests to assure products are safe and effective to use in the clinic. However, one of the key challenges for analytical methods in radiopharmacy is the narrow time frame where the analysis must be completed due to the limited half-life of radiomolecules. Radiochemical purity and identity are critical tests to control the success of radiolabeling. These parameters are easily determined by thin-layer chromatography methods (TLC) in some widely used molecules such as [18F]FDG. However, for new diagnostic and therapeutic agents

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Ahmed, Feruza, Tadele Eticha, Ariaya Hymete, and Ayenew Ashenef. "Principles and Applications of Ultra-High-Performance Liquid Chromatography." In High Performance Liquid Chromatography - Recent Advances and Applications [Working Title]. IntechOpen, 2023. http://dx.doi.org/10.5772/intechopen.110540.

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The science of separation had advanced significantly with the development of ultra-high-performance liquid chromatography (UHPLC), a brand-new type of liquid chromatography. The need for the evolution of HPLC into UHPLC has been driven by the continuously evolving of packing material modifications that affect the separation of mixtures. The separation process of analytes is completed in a substantially decreased amount of time due to the lower particle sizes, which increases surface area of interaction allowing reduction of column length to one-third; thus, shorter columns are employed in UHPL

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Conference papers on the topic "Chromatographic impurity"

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Yang, Li-ling, and Qin Zhan. "Analysis of Trace Components in Neon by Gas Chromatography." In 2022 29th International Conference on Nuclear Engineering. American Society of Mechanical Engineers, 2022. http://dx.doi.org/10.1115/icone29-92413.

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Abstract In order to complete the test of trace concentrations in neon carrier gas of solid tritium breeder system for fusion reactor, it is very necessary to establish a high precision analytical system and develop a method of Gas Chromatography (GC). The GC system was composed of three detectors and five separated columns and other auxiliary systems, meanwhile it has established analysis methods of testing trace He, H2 and impurity components in Ne carrier gas. The results showed that the Relative Standard Deviation (RSD) values of the concentration and peak area of each component were less

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Pusfitasari, Eka Dian, Hendris Hendarsyah, Salahuddin, and Novita Ariani. "Identification of di(ethylhexyl) phthalate as impurity in the analysis by using chromatography gas tandem mass spectrometry." In INTERNATIONAL SYMPOSIUM ON APPLIED CHEMISTRY (ISAC) 2016. Author(s), 2017. http://dx.doi.org/10.1063/1.4973186.

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Mokhtari, R., K. Ghahramani, S. Khojamli, D. Mihrin, and K. L. Feilberg. "Experimental Investigation of the Effect of Major Impurities in the CO2 Stream on Carbon Storage in Chalk Reservoirs." In SPE Europe Energy Conference and Exhibition. SPE, 2024. http://dx.doi.org/10.2118/220099-ms.

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Abstract Depleted oil and gas reservoirs in the Danish sector of the North Sea are predominantly composed of chalk, characterized by high porosity, low permeability, and reactivity. While storing CO2 in these reservoirs presents challenges, due to the reactivity of calcium carbonate and the low permeability, mitigating the risks could unlock substantial CO2 storage capacity. This study specifically investigates the impact of major reactive impurities such as H2S, NO2, and SO2 in the injected CO2 stream on calcite dissolution and its implications for rock integrity. These impurities can be pres

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