Development of validated stability-indicating assay methods--critical review.
15 Jun 2002-Journal of Pharmaceutical and Biomedical Analysis (Elsevier)-Vol. 28, Iss: 6, pp 1011-1040
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.
About: This article is published in Journal of Pharmaceutical and Biomedical Analysis.The article was published on 2002-06-15. It has received 694 citations till now.
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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
Cites background from "Development of validated stability-..."
...Also a sufficient run time after the drug peak is to be allowed to obtain the degradants peak eluting after the drug peak [19]....
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...Log P and solubility helps select mobile phase and sample solvent while pKa value helps determine the pH of the mobile phase [19]....
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...Bakshi and Singh [19] discussed some critical issues about developing stability indicating methods....
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...Both these reasons are strong enough to suggest that as normal as possible conditions should be used for causing the decomposition of the drug [19]....
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...Singh and Rehman [45] discussed the role of hyphenated systems for the isolation of degradants and impurities....
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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
TL;DR: This study demonstrated the suitability of filter paper blood spots paper for collection of serum antibodies, and provided clear guidelines for the treatment and storage of filter papers which emphasize the importance of desiccation and minimisation of time spent at ambient temperatures.
Abstract: Blood spots collected onto filter paper are an established and convenient source of antibodies for serological diagnosis and epidemiological surveys. Although recommendations for the storage and analysis of small molecule analytes in blood spots exist, there are no published systematic studies of the stability of antibodies under different storage conditions. Blood spots, on filter paper or glass fibre mats and containing malaria-endemic plasma, were desiccated and stored at various temperatures for different times. Eluates of these spots were assayed for antibodies against two Plasmodium falciparum antigens, MSP-119 and MSP2, and calculated titres used to fit an exponential (first order kinetic) decay model. The first order rate constants (k) for each spot storage temperature were used to fit an Arrhenius equation, in order to estimate the thermal and temporal stability of antibodies in dried blood spots. The utility of blood spots for serological assays was confirmed by comparing antibodies eluted from blood spots with the equivalent plasma values in a series of samples from North Eastern Tanzania and by using blood spot-derived antibodies to estimate malaria transmission intensity in this site and for two localities in Uganda. Antibodies in spots on filter paper and glass fibre paper had similar stabilities but blood was more easily absorbed onto filter papers than glass fibre, spots were more regular and spot size was more closely correlated with blood volume for filter paper spots. Desiccated spots could be stored at or below 4°C for extended periods, but were stable for only very limited periods at ambient temperature. When desiccated, recoveries of antibodies that are predominantly of IgG1 or IgG3 subclasses were similar. Recoveries of antibodies from paired samples of serum and of blood spots from Tanzania which had been suitably stored showed similar recoveries of antibodies, but spots which had been stored for extended periods at ambient humidity and temperature showed severe loss of recoveries. Estimates of malaria transmission intensity obtained from serum and from blood spots were similar, and values obtained using blood spots agreed well with entomologically determined values. This study has demonstrated the suitability of filter paper blood spots paper for collection of serum antibodies, and provided clear guidelines for the treatment and storage of filter papers which emphasize the importance of desiccation and minimisation of time spent at ambient temperatures. A recommended protocol for collecting, storing and assaying blood spots is provided.
217 citations
Cites background from "Development of validated stability-..."
...Stability testing is an integral part of pharmaceutical development [41,42], although most regimes are intended to address a relatively modest shelf-life....
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References
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01 Jan 1979
TL;DR: In this paper, the Chemical Stability of Pharmaceuticals (CSOP) of pharmaceuticals has been studied in terms of the chemical stability of pharmaceutical drugs and their stability in pharmaceuticals.
Abstract: Chemical stability of pharmaceuticals , Chemical stability of pharmaceuticals , کتابخانه مرکزی دانشگاه علوم پزشکی تهران
244 citations