Browsing by Author "Abd El-Rahman M.K."

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    A new platform for profiling degradation-related impurities via exploiting the opportunities offered by ion-selective electrodes: Determination of both diatrizoate sodium and its cytotoxic degradation product
    (AOAC International, 2018) Riad S.M.; Abd El-Rahman M.K.; Fawaz E.M.; Shehata M.A.; Cairo University; Faculty of Pharmacy; Analytical Chemistry Department; Kasr-El Aini St; Cairo; 11562; Egypt; October University for Modern Sciences and Arts; Faculty of Pharmacy; Analytical Chemistry Department; 6th of October City; Egypt
    Although the ultimate goal of administering active pharmaceutical ingredients (APIs) is to save countless lives, the presence of impurities and/or degradation products in APIs or formulations may cause harmful physiological effects. Today, impurity profiling (i.e., the identity as well as the quantity of impurity in a pharmaceutical) is receiving critical attention from regulatory authorities. Despite the predominant use of spectroscopic and chromatographic methods over electrochemical methods for impurity profiling of APIs, this work investigates the opportunities offered by electroanalytical methods, particularly, ion-selective electrodes (ISEs), for profiling degradation-related impurities (DRIs) compared with conventional spectroscopic and chromatographic methods. For a meaningful comparison, diatrizoate sodium (DTA) was chosen as the anionic X-ray contrast agent based on its susceptibility to deacetylation into its cytotoxic and mutagenic degradation product, 3,5-diamino-2,4,6 triiodobenzoic acid (DTB). This cationic diamino compound can be also detected as an impurity in the final product because it is used as a synthetic precursor for the synthesis of DTA. In this study, four novel sensitive and selective sensors for the determination of both DTA and its cytotoxic degradation products are presented. Sensors I and II were developed for the determination of the anionic drug, DTA, and sensors III and IV were developed for the determination of the cationic cytotoxic impurity. The use of these novel sensors not only provides a stability-indicating method for the selective determination of DTA in the presence of its degradation product, but also permits DRI profiling. Moreover, a great advantage of these proposed ISE systems is their higher sensitivity for the quantification of DTB relative to other spectroscopic and chromatographic methods, so it can measure trace amounts of DTB impurities in DTA bulk powder and pharmaceutical formulation without a need for preliminary separation. � 2018 AOAC International. All rights reserved.
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    Screen printed ion selective electrodes as a fully integrated PAT tool: Application to the analysis and impurity profiling of diatrizoate sodium
    (Electrochemical Society Inc., 2018) Fawaz E.M.; Abd El-Rahman M.K.; Riad S.M.; Shehata M.A.; Analytical Chemistry Department; Faculty of Pharmacy; Cairo University; Cairo; 11562; Egypt; Analytical Chemistry Department; Faculty of Pharmacy; October for Modern Sciences and Arts University; Cairo; Egypt
    Conventional pharmaceutical manufacturing is generally accomplished via batch processing followed by laboratory testing conducted on some representative samples collected to evaluate batch quality. However, today significant opportunities exist for improving pharmaceutical quality assurance through innovation in process development and analysis. FDA's guidance for pharmaceutical industry has defined Process Analytical Technology (PAT) as a system for designing, analyzing, and controlling manufacturing through timely measurements,with the goal of ensuring final product quality.Nevertheless, pharmaceutical companies are encouraged to develop and implement innovative PAT tools for designing, analyzing, and controlling manufacturing through real-time strategies (i.e., during processing) of critical quality attributes of raw and final product. The goal of PAT is that quality cannot be tested into products; it should be built-in or should be by design. Furthermore, FDA stated that sensor-based measurements could pave the way to built-in product quality assurance which is the key to PAT development. From this perspective, this scientific approach presents screen-printed ISEs (SPEs) as a potential real-time analyzer and PAT-tool. Diatrizoate sodium (DTA) was chosen as a model analyte, it is a widely used X-ray contrast agent that is susceptible to degradation into a cytotoxic and mutagenic compound, that can be also used as its precursor. Two SPEs were fabricated and used successfully in the analysis of both DTA and its potential impurity. The proposed SPEs have the advantage of being real-time analyzers that could be fully integrated into the production cycle giving a key to a promising competent PAT-tool. � 2018 The Electrochemical Society.