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Relevant bibliographies by topics / Drug forced degradation

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Journal articles

Academic literature on the topic 'Drug forced degradation'

Author: Grafiati

Published: 4 June 2021

Last updated: 15 February 2022

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Journal articles on the topic "Drug forced degradation"

1

Yulianita, Rini, Iyan Sopyan, and Muchtaridi Muchtaridi. "FORCED DEGRADATION STUDY OF STATINS: A REVIEW." International Journal of Applied Pharmaceutics 10, no. 6 (2018): 38. http://dx.doi.org/10.22159/ijap.2018v10i6.29086.

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Forced degradation study is the degradation of new drug substances and drug products in more severe conditions than accelerated conditions. Forced degradation study were conducted to demonstrate the specificity of stability-indicating methods, providing insight into degradation pathways and drug degradation products, assisting in the elucidation of degradation product structures, identifying degradation products that could be spontaneously generated during storage and use of drugs and to facilitate improvement in manufacturing process and formulation corresponding with accelerated stability st

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2

Bhaskar, Rajveer, Monika Ola, Vinit Agnihotri, Arjun Chavan, and Harpalsing Girase. "Current Trend in Performance of Forced Degradation Studies for Drug Substance and Drug Product’s." Journal of Drug Delivery and Therapeutics 10, no. 2-s (2020): 149–55. http://dx.doi.org/10.22270/jddt.v10i2-s.4040.

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The stability of a new drug substances and new drug products is a vital parameter which may affect purity, safety & potency. Changes in drug stability can threat patient safety by formation of toxic degradation products or deliver to lower dose than expected. Therefore it is to know the purity profile & behaviour of a drug substances under the various environmental condition. Forced Degradation studies show the chemical behavior of the molecule which in turn helps in the development of new formulation & package . Degradation study is required to the design of a regulatory compliant

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3

Mladenovic, Aleksandar, Milka Jadranin, Aleksandar Pavlovic, et al. "Liquid chromatography and liquid chromatography-mass spectrometry analysis of donepezil degradation products." Chemical Industry and Chemical Engineering Quarterly 21, no. 3 (2015): 447–55. http://dx.doi.org/10.2298/ciceq141023047m.

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This study describes the investigation of degradation products of donepezil (DP) using stability indicating RP-HPLC method for determination of donepezil, which is a centrally acting reversible acetylcholinesterase inhibitor. In order to investigate the stability of drug and formed degradation products, a forced degradation study of drug sample and finished product under different forced degradation conditions has been conducted. Donepezil hydrochloride and donepezil tablets were subjected to stress degradation conditions recommended by International Conference on Harmonization (ICH). Donepezi

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4

Mehta, Tushar N., Atul K. Patel, Gopal M. Kulkarni, and Gunta Suubbaiah. "Determination of Rosuvastatin in the Presence of Its Degradation Products by a Stability-Indicating LC Method." Journal of AOAC INTERNATIONAL 88, no. 4 (2005): 1142–47. http://dx.doi.org/10.1093/jaoac/88.4.1142.

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Abstract A forced degradation study was successfully applied for the development of a stability-indicating assay method for determination of rosuvastatin Ca in the presence of its degradation products. The method was developed and optimized by analyzing the forcefully degraded samples. Degradation of the drug was done at various pH values. Moreover, the drug was degraded under oxidative, photolytic, and thermal stress conditions. Mass balance between assay values of degraded samples and generated impurities was found to be satisfactory. The proposed method was able to resolve all of the possib

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5

Jaya P. Ambhore, Vaibhav S. Adhao, Rameshwar S. Cheke, Rameshwar S. Cheke, Ritesh R. Popat, and Shital J. Gandhi. "Futuristic review on progress in force degradation studies and stability indicating assay method for some antiviral drugs." GSC Biological and Pharmaceutical Sciences 16, no. 1 (2021): 133–49. http://dx.doi.org/10.30574/gscbps.2021.16.1.0172.

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Force degradation studies of drug substance give perceptive knowledge about the intrinsic stability of the molecule as well as possible degradants which formed during the shelf life of drug and thus, aid within the successive development of its stable formulation. A number of analytical methods with hyphenated techniques are required for the identification, determination and characterization of degraded product and impurities produce during different conditions of stress studies; Chromatographic methodology play a vital role in the field of impurity and degradation profiling .This review summa

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6

CARLSON, E., W. CHANDLER, I. GALDO, T. KUDLA, and C. TA. "Automated Integrated Forced Degradation and Drug-Excipient Compatibility Studies." Journal of the Association for Laboratory Automation 10, no. 6 (2005): 374–80. http://dx.doi.org/10.1016/j.jala.2005.09.005.

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7

Bansal, Gulshan, Manjeet Singh, Kaur Chand Jindal, and Saranjit Singh. "Ultraviolet-Photodiode Array and High-Performance Liquid Chromatographic/Mass Spectrometric Studies on Forced Degradation Behavior of Glibenclamide and Development of a Validated Stability-Indicating Method." Journal of AOAC INTERNATIONAL 91, no. 4 (2008): 709–19. http://dx.doi.org/10.1093/jaoac/91.4.709.

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Abstract A forced degradation study on glibenclamide was performed under conditions of hydrolysis, oxidation, dry heat, and photolysis and a high-performance column liquid chromatographic-ultraviolet (HPLC-UV) method was developed to study degradation behavior of the drug under the forced conditions. The degradation products formed under different forced conditions were characterized through isolation and subsequent infrared/nuclear magnetic resonance/mass spectral analyses, or through HPLC/mass spectrometric (HPLC/MS) studies. The drug degraded in 0.1 M HCl and water at 85C toamajor degradati

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8

Roberto de Alvarenga Junior, Benedito, and Renato Lajarim Carneiro. "Chemometrics Approaches in Forced Degradation Studies of Pharmaceutical Drugs." Molecules 24, no. 20 (2019): 3804. http://dx.doi.org/10.3390/molecules24203804.

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Chemometrics is the chemistry field responsible for planning and extracting the maximum of information of experiments from chemical data using mathematical tools (linear algebra, statistics, and so on). Active pharmaceutical ingredients (APIs) can form impurities when exposed to excipients or environmental variables such as light, high temperatures, acidic or basic conditions, humidity, and oxidative environment. By considering that these impurities can affect the safety and efficacy of the drug product, it is necessary to know how these impurities are yielded and to establish the pathway of t

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9

Michail, Karim, Hoda M. Daabees, Youssef Beltagy, Magdi Abdel-Khalek, and Mona M. Khamis. "Stress Degradation Assessment of Lamotrigine Using a Validated Stability-Indicating HPTLC Method." Journal of Chemistry 2013 (2013): 1–6. http://dx.doi.org/10.1155/2013/608196.

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In this work, a sensitive and stability-indicating HPTLC method for the determination of lamotrigine is presented. According to the International Conference on Harmonization guidelines Q1A, lamotrigine was exposed to a variety of stress conditions; these include heating in acidic, basic and neutral media. Its stability towards oxidative stress, humidity, high temperature and direct sunlight was also examined. Separation of the drug from its forced degradation impurities was achieved using TLC silica gel plates and a mobile phase composed of ethyl acetate: methanol: ammonia. The linear regressi

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10

Sharma, Ritesh, and Shyam Pancholi. "RP-HPLC-DAD method for determination of olmesartan medoxomil in bulk and tablets exposed to forced conditions." Acta Pharmaceutica 60, no. 1 (2010): 13–24. http://dx.doi.org/10.2478/v10007-010-0010-2.

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RP-HPLC-DAD method for determination of olmesartan medoxomil in bulk and tablets exposed to forced conditionsA simple, sensitive and precise RP-HPLC-DAD method was developed and validated for the determination of olmesartan medoxomil (AT-II receptor blocker) in the presence of its degradation products. Olmesartan medoxomil and all the degradation products were resolved on a C18column with the mobile phase composed of methanol, acetonitrile and water (60:15:25,V/V/V, pH 3.5 by orthophosphoric acid) at 260 nm using a photodiode array detector. The method was linear over the concentration range o

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