Quality is the most important attribute of any pharmaceutical product. The source of pharmaceutical products varies greatly, from plants/ marine sources (natural resources), synthetic methods or recombinant DNA methods or a combination of any of these. This necessitates regulatory aspects as defining the standards for a quality product belonging to each of these categories would be a difficult task. Impurity profiling is the common name of a group of analytical activities, the aim of which is the detection, identification/structure elucidation and quantitative determination of organic and inorganic impurities, as well as residual solvents in bulk drugs and pharmaceutical formulations. Impurity profiling is very important during the synthesis of drug substances and manufacture of dosage forms, as it can provide crucial data regarding the toxicity, safety, various limits of detection, and limits of quantitation, of several organic and inorganic impurities, usually accompany with bulk drugs and finished products.
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