Relevant bibliographies by topics / ICH Guidelines Impurity profiling

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Academic literature on the topic 'ICH Guidelines Impurity profiling'

Author: Grafiati
Published: 3 June 2025
Last updated: 1 August 2025

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Journal articles on the topic "ICH Guidelines Impurity profiling"

1

Yash, B. Pokiya *1 Vaishali V. Karkhanis2. "Impurity Profiling of Anti-Malarial Drugs." International Journal in Pharmaceutical Sciences 2, no. 8 (2024): 3963–89. https://doi.org/10.5281/zenodo.13619629.

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Impurities are the unwanted materials which can interact with the pharmaceutical product and affects the quality of the product or the formulation. According to ICH guidelines, impurity is the part of the drug substance which affects the quality and purity of the active ingredients. Therefore, its identification and control is the major issue in the formulation industries. For the control and the limits of the impurity in the pharmaceutical dosage form, International Conference on Harmonization (ICH) formulated the guidelines for the impurity control and management. In this review, list of the
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2

Mansi, Rana*1 Vikram Pandya2. "Overview On Impurity Profiling For Pharmaceutical Drug Candidates." International Journal in Pharmaceutical Sciences 2, no. 4 (2024): 586–93. https://doi.org/10.5281/zenodo.10955539.

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Impurity profiling plays a crucial role in the pharmaceutical industry to ensure the safety, efficacy, and quality of drug products. This review provides an overview of impurity profiling methodologies, focusing on pharmaceutical drug candidates. It begins with an introduction to impurities, including their classification and sources. Moreover, the importance of impurity thresholds and regulatory guidelines established by organizations like the International Council for Harmonisation (ICH) and the United States Pharmacopeia (USP) is highlighted. Furthermore, strategies for impurity control dur
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3

Gogna, Kunal. "Regulatory aspects of Impurity profiling." International Journal of Drug Regulatory Affairs 8, no. 4 (2020): 45–54. http://dx.doi.org/10.22270/ijdra.v8i4.433.

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Quality, safety and efficacy of pharmaceuticals play an important role in drug therapy. The safety attribute of drug is established by its pharmacological or toxicological profile along with adverse effects caused by impurities in bulk and dosage form. Impurities present in drug often possess undesired pharmacological or toxicological effects which outweighs the benefits of drug therapy. Recently, many impurity cases have been reported for e.g. NDMA (N-nitroso dimethylamine) impurity in drug product Ranitidine. This may be due to inappropriate follow of impurity related regulatory guidelines o
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B, Bhagwat Ashlesha, and Khedkar K. M. "Impurity Profiling: A Review." Asian Journal of Pharmaceutical Research and Development 10, no. 2 (2022): 135–43. http://dx.doi.org/10.22270/ajprd.v10i2.1052.

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Impurities are any substances, such as starting materials or intermediates, that coexist with the parent drug or arise from side reactions. Interest in impurities present in APIs continues to grow. Nowadays, not only purity profile but also impurity profile is mandated by various regulatory agencies. Impurity profiling is a generic name for a group of analytical working groups such as describing, quantifying and characterizing identified and unidentified impurities present in a new drug substance. Impurity profiling is a novel approach aimed at detecting, identifying, structuring and quantifyi
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Swati, Dubey Ravindra Kumar Pandey Shiv Shankar Shukla*. "IMPURITY PROFILING AND DRUG CHARACTERIZATION: BACKDROP AND APPROACH." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 04 (2018): 2499–515. https://doi.org/10.5281/zenodo.1218717.

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Impurities are always an ‘essential evil’, that will however be present with the drug products with but with the dawn of more safety based limits for controlling the related impure substances (ICH Q3A-D and M7) it can be relied that such controlling authorities will better comprehend the course of action and consent to an appropriate tolerable limits to possibility (commercial and patient needs).Impurity produced either through formulation or in the lead ageing of both API’s and formulated products in medicines. These unwanted chemicals, present even in small amount, may infl
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6

Phuge, Ashish, Rekha Bhalerao, and Vijaya Barge. "A Review On Chromatographic Method Development And Impurity Profiling." PDEAS International Journal of Research in Ayurved and Allied Sciences 1, no. 1 (2019): 28–32. https://doi.org/10.63778/pdeasijraas-arjcpl/2019_21530.

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Stability indicating assay method (SIAM) is a validated quantitative analytical procedure that can detect changes with time in the properties of the drug substance and drug product under defined storage conditions. It accurately measures the API without interference from other substances and is sensitive enough to detect and quantify even small amounts of degradation products/impurities. To develop a SIAM, stress testing in the form of forced degradation should be carried out as per International Conference On Harmonization (ICH) Guidelines at an early stage so that impurities and degradation
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7

Orlandini, Serena, Gabriel Hancu, Zoltán-István Szabó, et al. "New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis Methods." Molecules 27, no. 20 (2022): 7058. http://dx.doi.org/10.3390/molecules27207058.

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Capillary electrophoresis (CE) is a potent method for analyzing chiral substances and is commonly used in the enantioseparation and chiral purity control of pharmaceuticals from different matrices. The adoption of Quality by Design (QbD) concepts in analytical method development, optimization and validation is a widespread trend observed in various analytical approaches including chiral CE. The application of Analytical QbD (AQbD) leads to the development of analytical methods based on sound science combined with risk management, and to a well understood process clarifying the influence of met
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8

Bhole, R. P., S. R. Jagtap, C. G. Bonde, and Y. B. Zambare. "Development and validation of stability indicating HPTLC method for estimation of pirfenidone and characterization of degradation product by using mass spectroscopy." Bulletin of the Karaganda University. "Chemistry" series 99, no. 3 (2020): 51–60. http://dx.doi.org/10.31489/2020ch3/51-60.

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Pirfenidone is used as a novel antifibrotic agent approved for mild-to-moderate idiopathic pulmonary fibrosis. An extensive literature search revealed that, method validation by high-performance thin-layer chromatography (HPTLC) and structural determination by tandem mass spectrometry (MS/MS) method was not reported till date. Precoated silica gels plates were used as a stationary phase. Methanol: ethyl acetate: toluene (1:2:7 v/v) was delivered best separation at 315 nm (Rf 0.49±0.03) by densitometry analysis. Degradation analysis was performed as per ICH guidelines Q2 (R1). Isolation of degr
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9

Peddi, Pavani, P. T. S. R. K. Prasada Rao, Chebolu Naga Sesha Sai Pavan Kumar, Nannapaneni Usha Rani, and S. Lakshmi Tulasi. "Impurity Profiling and a Stability Indicating Advanced Liquid Chromatographic Method Development and Validation for the Estimation of Related Impurities of Anagrelide." Asian Journal of Chemistry 36, no. 2 (2024): 325–30. http://dx.doi.org/10.14233/ajchem.2024.30785.

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A novel, streamlined and highly selective isocratic liquid chromatographic method has been developed for the quantification of impurities present in anagrelide. Exceptional resolution between anagrelide and its impurities was accomplished utilizing a Waters Nova Pack C18 column (250 mm × 4.6 mm, 4 µm), employing a phosphate buffer with a pH of 4.4 as mobile phase A and a blend of acetonitrile and methanol with buffer in a 30:40:30 v/v/v ratio as mobile phase B. The column oven was maintained at 35 ºC and the mobile phase flowed at a constant rate of 1.0 mL/min, while detection was set at 254 n
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10

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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Book chapters on the topic "ICH Guidelines Impurity profiling"

1

Saha, Gourab. "Introduction to Pharmaceutical Analysis." In Analytical Methods for Drug Development. THINKPLUS PHARMA PUBLICATIONS, 2025. https://doi.org/10.69613/mg7y6110.

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Pharmaceutical analysis serves as the cornerstone of drug development, providing critical tools for quality assessment throughout product lifecycles. Analytical chemistry principles establish the scientific foundation for identifying, quantifying, and characterizing drug substances and products. These methods fulfill essential functions from early discovery through commercialization, including impurity profiling, stability determination, and quality control. Current FDA, EMA, and ICH guidelines create a regulatory framework that governs analytical procedures globally. The pharmaceutical indust
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2

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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