Relevant bibliographies by topics / Genotoxic impurities and Method validation

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  1. Journal articles
  2. Dissertations / Theses
  3. Book chapters
  4. Conference papers

Academic literature on the topic 'Genotoxic impurities and Method validation'

Author: Grafiati
Published: 5 June 2025
Last updated: 1 August 2025

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Journal articles on the topic "Genotoxic impurities and Method validation"

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Siva, Krishna Nachaka, Babu Kodavati Ramesh, Vaidyanathan Gopal, Paila Sattibabu, and Palnati Narmada. "Quantitative Determination of Trace Levels of Nitromethane and Its Analog Impurities by Using HS-GC-MS." American Journal of PharmTech Research 12, no. 4 (2022): 48–64. https://doi.org/10.5281/zenodo.7124322.

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ABSTRACT A specific HS-GC-MS method has been developed, optimized and validated for the determination of five genotoxic impurities namely Nitromethane, Nitroethane, 2-Nitropropane, 1-Nitropropane and 1-Nitrobutane in TRB-G, intermediate of Trabectedin drug substance. Chromatographic separation of five genotoxic impurities was achieved on Capillary GC column (Rtx-1701. Fused silica capillary column; 30 m length; 0.25mm internal diameter. coated with 14% Cyanopropylphenyl and 86% dimethyl polysiloxane stationary phase of 1.0 µm film thickness) and passing helium carrier gas with Electron I
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N, Balaji, and Sayeeda Sultana. "ULTRA-HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC DETERMINATION OF GENOTOXIC IMPURITIES IN FEBUXOSTAT DRUG SUBSTANCE AND PRODUCTS." Asian Journal of Pharmaceutical and Clinical Research 10, no. 1 (2016): 324. http://dx.doi.org/10.22159/ajpcr.2017.v10i1.15381.

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ABSTRACTObjective: An efficient ultra-high performance liquid chromatographic (UHPLC or Infinity LC 1290) method has been developed and validated for thequantification of possible carcinogenic or genotoxic impurities in febuxostat drug substances and drug products at 18 µg/ml level.Methods: This method includes the conclusion of four potential genotoxic impurities in febuxostat. The mobile phase is trifluoroacetic acid,acetonitrile, and water with linear gradient elution. The UHPLC column used for the analysis was zorbax RRHD eclipse plus C18 with a length of100 mm, internal diameter of 2.1 mm
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Balaji, N., and Sayeeda Sultana. "TRACE LEVEL DETERMINATION AND QUANTIFICATION OF POTENTIAL GENOTOXIC IMPURITIES IN DASATINIB DRUG SUBSTANCE BY UHPLC/INFINITY LC." International Journal of Pharmacy and Pharmaceutical Sciences 8, no. 10 (2016): 209. http://dx.doi.org/10.22159/ijpps.2016v8i10.14020.

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<p class="Default"><strong>Objective: </strong>A simple, cost-effective and mass compatible ultra-high fast performance liquid chromatographic (Agilent-Infinity LC 1290) method has been developed and validated for the determination of potentially genotoxic impurities in dasatinib active pharmaceutical ingredients.</p><p class="Default"><strong>Methods: </strong>This method comprises the determination of three possible genotoxic impurities in dasatinib. The mobile phase is trifluoroacetic acid, acetonitrile and water with linear gradient elution curve n
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M. Manivannan, P. Ilayaraja, and P. Parthiban. "GC-MS METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF GENOTOXIC TOSYLATES IN TENELIGLIPTIN." RASAYAN Journal of Chemistry 18, no. 03 (2025): 1696–703. https://doi.org/10.31788/rjc.2025.1839365.

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In this study, a specific and robust Gas Chromatography-Mass Spectrometry (GC-MS) method was meticulously developed, optimized, and validated for the precise determination of the genotoxic tosylate impurities in Teneligliptin. The method was optimized on an Agilent 5977B GC/MSD system equipped with a capillary column (HP-5MS, 30 m × 0.32 mm x 1.0 μm) using helium as the carrier gas. Detection of the impurities was achieved using selective ion monitoring mode at specific mass-to-charge ratios. The method excelled in validation for various parameters, including specificity, sensitivity, precisio
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Patel, Haresh B., Rohit H. Dave, Sandip Vadariya, Hitin Hirpara, and Trushar Patel. "Development and Validation of HPLC Method for the Quantification of Impending Genotoxic Impurities in Dapson Drug Substances." Biotechnology Journal International 28, no. 4 (2024): 1–17. http://dx.doi.org/10.9734/bji/2024/v28i4724.

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The assessment of toxicological concentrations of possible genotoxic contaminants in drug substances was regarded as an important and challenging discipline . The International Conference and Harmonization (ICH) recommended that most pharmaceutical products be allowed to include 1.5 μg/day of a genotoxic contaminant. The goal study was to develop a quick and accurate HPLC method for measuring potential genotoxic impurities (PGIs) in Dapson drug substances. The chromatographic conditions were appropriately optimized with the Phosphate and Acetate buffer on C18 & C8 columns to achieve a dece
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Rao P.Y.G, Sreenivasa Rao B, Suresh Reddy K.V.N, and Sudhakar Ch. "A Selective and Sensitive Method for Simultaneous Quantification of Genotoxic Impurities in Penciclovir drug substance and its dosage forms using UPLC-MS/MS." International Journal of Research in Pharmaceutical Sciences 11, no. 4 (2020): 5772–76. http://dx.doi.org/10.26452/ijrps.v11i4.3224.

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A selective, rapid and sensitive method was developed for the determination of genotoxic impurities (2-Amino-6-chloro purine and Bromo compound) in Penciclovir drug substance using RPUPLC-MS/MS. The chromatographic separation was performed on Kromasil C8 column (150 mm x 4.6 mm, 5 μm) maintained at 45°C using 0.1%formic acids in water as buffer and acetonitrile through gradient programme. The flow rate was maintained at 0.5mL/min with an injection volume of 10 μL. For the quantification of genotoxic impurities, positive-electrospray ionisation (ESI) mode was selected. Penciclovir and its impur
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Suresh Kumar and Akash Singh Pawar. "Formation of nitrosamine impurities: Discussion and advanced method development and validation using LC-MS/MS for their detection." World Journal of Biology Pharmacy and Health Sciences 20, no. 3 (2024): 385–89. https://doi.org/10.30574/wjbphs.2024.20.3.1016.

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Nitrosamine impurities, known for their genotoxic and carcinogenic potential, have emerged as critical concerns in pharmaceutical manufacturing. Their presence in various drug substances and products has led to stringent regulatory actions globally. This report explores the formation mechanisms of nitrosamine impurities, including the subset of nitrosamine drug substance-related impurities (NDSRIs), which arise from API-specific interactions. Advanced analytical techniques such as LC-MS/MS, GC-MS/MS, and HRMS are reviewed for their efficacy in detecting and quantifying these impurities. The re
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Mohan, Bavireddi, Ramayanam Siva Kameswara Sharma, Devarakonda Ravi Kumar, Seshagiri Vijaya Murali Mohan Rao, and Nutulapati Venkata Satya Venugopal. "Determination of Genotoxic alkyl p-toluene Sulfonates in Cabazitaxel using LC-MS Method." Current Pharmaceutical Analysis 15, no. 7 (2019): 753–61. http://dx.doi.org/10.2174/1573412915666190522085818.

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Introduction: A suitable LC-MS method for the quantitative determination of genotoxic impurities such as alkyl p-toluene sulfonates in Cabazitaxel was developed. Alkyl p-toluene sulfonates were estimated by LC-MS method using Waters Symmetry C18 (75×4.6 mm), 3.5 µ column. Materials and Methods: Column temperature was maintained 40 °C. Injection volume was 10 µL and flow rate was set as 0.8 mL/min. Sampler temperature was maintained to 25 °C and run time was set as 25 minutes. The mobile phase was a mixture of ammonium acetate buffer and acetonitrile in 70:30(v/v) was used. Results: The method
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Vadlamani, Annapoorna, K. Ravindhranath, and B. Sreenivasa Rao. "Detection and Quantification of Two Potential Genotoxic Impurities in Telbivudine Active Pharmaceutical Ingredient by Targeted Ultra Performance LC-MS/MS Analysis." Asian Journal of Chemistry 34, no. 12 (2022): 3383–90. http://dx.doi.org/10.14233/ajchem.2022.26905.

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A new selective, rapid and highly sensitive method using reversed-phase ultra-performance liquid chromatography (RP-UPLC) coupled with mass analyzer was developed for the detection and quantification of two genotoxic impurities viz. 4-dimethyl aminopyridine (GTI-1) and 2-bromo-3,5-diacetyl thymidine (GTI-2) in Telbivudine drug substance. The separation of two genotoxic impurities was accomplished using Kromasil C8 column (100 mm × 4.6 mm, 3.5 μm) maintained at 45 ºC using formic acid (0.1%) as buffer solution and gradient grade acetonitrile with 0.5 mL/min flow rate. Both GTIs were quantified
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M., Manivardhan Reddy*1 G. Sampath Kumar Reddy2 and K. Ramadevi3. "Comprehensive Insights into High-Performance Liquid Chromatography for Pharmaceutical Analysis: Focus on Genotoxic Impurities." International Journal of Pharmaceutical Sciences 3, no. 1 (2025): 2031–46. https://doi.org/10.5281/zenodo.14729254.

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High-Performance Liquid Chromatography (HPLC) is a crucial analytical technique widely employed in the pharmaceutical industry for the identification, quantification, and control of genotoxic impurities (GTIs). These impurities, such as nitrosamines, pose significant public health risks due to their carcinogenic potential, necessitating precise detection and stringent regulatory control. This review explores the fundamentals of HPLC, including its principles, instrumentation, operational methodologies, and various applications in pharmaceutical analysis. It emphasizes the development and valid
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Dissertations / Theses on the topic "Genotoxic impurities and Method validation"

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Rodrigues, Cristina Dara Velho. "Do generic pharmaceutical drugs contain more impurities?" Master's thesis, 2019. http://hdl.handle.net/10773/27812.

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Generic drugs are currently sold all over European union presenting a much more appealing price than their corresponding pharmaceutical drugs from other brands, which frequently influence the consumer regarding the choice of the drug brand. The lower prices are mostly due to the fact that the legislation applied to the generic drugs is currently simplified comparatively to the respective reference pharmaceutical drugs legislation, allowing that the pharmaceutical industry produce generic drugs at a lower cost. In order to reduce production costs even more, are often use different excipients an
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Book chapters on the topic "Genotoxic impurities and Method validation"

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Kleinschmidt, Gerd. "Case Study: Validation of An HPLC-Method for Identity, Assay, and Related Impurities." In Method Validation in Pharmaceutical Analysis. Wiley-VCH Verlag GmbH & Co. KGaA, 2005. http://dx.doi.org/10.1002/3527604685.ch3.

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Riley, Christopher M., A. M. Clarke, and E. Kikovska-Stojanovska. "Assay and impurities: method validation." In Specification of Drug Substances and Products. Elsevier, 2020. http://dx.doi.org/10.1016/b978-0-08-102824-7.00011-7.

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Hertzler, Russell L., Mark D. Johnson, Teodora Moldovan, et al. "Small-Molecule Pharmaceutical Impurities Test Method Validation: Precision Acceptance Criterion." In Chromatographic Method Development. Jenny Stanford Publishing, 2019. http://dx.doi.org/10.1201/9780429201721-14.

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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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Bilone, O. S., P. O. Bilone, A. P. Dewani, N. I. Kochar, and A. V. Chandewar P. "ANALYTICAL QUALITY BY DESIGN." In Futuristic Trends in Pharmacy & Nursing Volume 3 Book 4. Iterative International Publishers, Selfypage Developers Pvt Ltd, 2024. http://dx.doi.org/10.58532/v3bipn4p5ch1.

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Analytical development is considered as an integral part of the pharmaceutical product life-cycle, where establishment of an effective, cost-effective, robust, sensitive, and specific analytical methods are always required for analysis of drug(s), degradation product(s), and impurities in dosage forms. As analytical method development involves a series of factors that are critically responsible for attributing variability in the method performance; thus implication of systematic analytical development practices such as quality by design (QbD) is very useful for optimizing the method performanc
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Conference papers on the topic "Genotoxic impurities and Method validation"

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Kaminski, Martin. "MCPD and glycidyl esters - presentation of a modular analysis method for oils and fats as well as compound foods." In 2022 AOCS Annual Meeting & Expo. American Oil Chemists' Society (AOCS), 2022. http://dx.doi.org/10.21748/fplf3753.

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3-Monochloropropane-1,2-diol (3-MCPD) esters (3-MCPDE) and glycidyl esters (GE) are processing contaminants mainly formed during the deodorization of refined vegetable and fish oils and pose a serious health risk due to their potential genotoxic and carcinogenic properties. In recent years, numerous standards have been published to analyze these contaminants by robust and accurate analytical methods in oils and fats (seven AOCS methods, four ISO standards), oil-based emulsions (one AOCS method), and infant formula (two AOAC first action methods). In addition, more and more additional food cate
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Kuhlmann, Jan, and Nicolaus von Mouillard. "Solutions for modern routine analysis of mycotoxins in edible oils." In 2022 AOCS Annual Meeting & Expo. American Oil Chemists' Society (AOCS), 2022. http://dx.doi.org/10.21748/pbep9435.

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Mycotoxins are a large and heterogenic group of biogenic organic compounds that can impact the quality and safety of foods. Due to the diversity of fungi, different kinds of foods are affected by different mycotoxins. Some of them have received special attention due to their high frequency of occurrence or due to their toxicity. For example, aflatoxin B1 is genotoxic and one of the most carcinogenic biogenic compounds known so far. Hence, it is not surprise that several authorities worldwide have set maximum levels for this compound as well as for the most relevant further mycotoxins in certai
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