Author
Monika Bakshi
Bio: Monika Bakshi is an academic researcher. The author has contributed to research in topics: Terazosin & Doxazosin. The author has an hindex of 9, co-authored 10 publications receiving 1287 citations.
Topics: Terazosin, Doxazosin, Secnidazole, Ornidazole
Papers
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TL;DR: This write-up provides a review on the development of validated stability-indicating assay methods (SIAMs) for drug substances and products and the shortcomings of reported methods with respect to regulatory requirements are highlighted.
694 citations
01 Jan 2000
TL;DR: In this paper, the authors proposed a classification system for categorization of drugs based on their inherent stability behavior, and flow charts have been drawn that are suggested to be followed for determining the stress test conditions for hydrolysis (under neutral, acid and alkaline conditions), oxidation, and photolysis.
Abstract: he International Conference on Harmonization (ICH) guideline entitled ‘Stability Testing of New Drug Substances and Products’ (Q1A) requires that stress testing be carried out to elucidate the inherent stability characteristics of the active substance (1). It suggests that the degradation products that are formed under a variety of conditions should be identified and degradation pathways established. It is stated that the testing should include the effect of temperature, humidity where appropriate; oxidation, photolysis and susceptibility to hydrolysis across a wide range of pH values. In the guideline, the study of the effect of temperature is suggested to be done in 10 C increments above the accelerated temperature test condition (e.g. 50 C, 60 C, etc.) and that of the humidity at a level of 75 percent or greater. No details are, however, provided for the study of oxidation, photolysis and hydrolysis at different pH values. In the absence of guidance, difficulties are faced by practitioners to decide on the stress conditions to be employed for a new drug at the time of initiation of forced decomposition studies. In this write-up the authors propose a classification system for categorization of drugs based on their inherent stability behaviour. Flow charts have been drawn that are suggested to be followed for determining the stress test conditions for hydrolysis (under neutral, acid and alkaline conditions), oxidation, and photolysis.
269 citations
TL;DR: The purpose of this two-part review is to provide a broad overview of the development of quantitative structure-property relationships (QSPR) and review the applications in pharmaceutical research.
118 citations
TL;DR: Degradation of ornidazole under different ICH prescribed stress conditions (hydrolysis, oxidation and photolysis), and establishment of a stability-indicating reversed-phase HPLC assay are described.
80 citations
TL;DR: This two-part review described the advantages and limitations of quantitative structure-property relationships (QSPR), and offered an overview of the components involved in the development of correlations1.
70 citations
Cited by
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TL;DR: This write-up provides a review on the development of validated stability-indicating assay methods (SIAMs) for drug substances and products and the shortcomings of reported methods with respect to regulatory requirements are highlighted.
694 citations
TL;DR: The current trends in performance of forced degradation studies are discussed by providing a strategy for conducting studies on degradation mechanisms and the analytical methods helpful for development of stability indicating method are described.
626 citations
01 Mar 2012
TL;DR: Stability studies ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as pre-requisite for the acceptance and approval of any pharmaceutical product.
Abstract: Stability studies ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as pre-requisite for the acceptance and approval of any pharmaceutical product These studies are required to be conducted in a planned way following the guidelines issued by ICH, WHO and or other agencies Importance of various methods followed for stability testing of pharmaceutical products, guidelines issued for stability testing and other aspects related to stability of pharmaceutical products have been presented in a concise manner in the present review
330 citations
TL;DR: This technique presents advantages such as the complete release of protein bound MDA with the alkaline hydrolysis step, the removal of interferents with n-butanol extraction, mobile phase without phosphate buffer and rapid analytical processes and run times.
285 citations