Journal ArticleDOI
Development of validated stability-indicating assay methods--critical review.
Monika Bakshi,Saranjit Singh +1 more
TLDR
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.read more
Citations
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Journal ArticleDOI
Development of forced degradation and stability indicating studies of drugs-A review.
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.
Journal ArticleDOI
Rapid quantification of malondialdehyde in plasma by high performance liquid chromatography-visible detection.
Denise Grotto,L.D. Santa Maria,Silvana Peterini Boeira,Juliana Valentini,Mariele Feiffer Charão,Angela M. Moro,Paulo C. do Nascimento,Valdeci Juarez Pomblum,Solange Cristina Garcia +8 more
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.
Journal ArticleDOI
Dried blood spots as a source of anti-malarial antibodies for epidemiological studies
Patrick H. Corran,Patrick H. Corran,Jackie Cook,Caroline A. Lynch,Heleen Leendertse,Alphaxard Manjurano,Jamie T. Griffin,Jonathan Cox,Tarekegn A. Abeku,Teun Bousema,Azra C. Ghani,Chris Drakeley,Eleanor M. Riley +12 more
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.
References
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Book
Practical HPLC method development
TL;DR: In this paper, the authors present a systematic approach to the Reversed-Phase Separation of Regular Samples, using a computer assisted method developed by computer assisted software development.
Book
Analytical profiles of drug substances
TL;DR: In this paper, the authors present the Cumulative Index of Cumulative Histories of Chemical Substances (CHS) for the first time, which is the most complete list.
Book
Drug stability : principles and practices
TL;DR: Solution kinetics kinetic pH profiles oxidation in solution catalysis, complexation, and photolysis solid state stability interactions of moisture with solids physical characterisation of solids preformulation physical testing development and validation of HPLC stability-indicating assays.
Journal ArticleDOI
Oxidative degradation of pharmaceuticals: theory, mechanisms and inhibition.
TL;DR: The present article reviews mechanistic details of autoxidation and chain oxidation processes, as well as the oxidation of selected functional groups commonly affected in drugs.
Book
Chemical stability of pharmaceuticals
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.