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By Lena Ohannesian

Exploring the research of prescribed drugs, together with polymorphic kinds, this publication discusses regulatory specifications in pharmaceutical product improvement and pharmaceutical checking out. It covers equipment of drug separation and methods similar to capillary electrophoresis for chromatographic separation of molecules. extra issues contain drug formula research utilizing vibrational and magnetic resonance spectroscopy and id of drug metabolites and decomposition items utilizing such innovations as mass spectrometry. The ebook presents greater than three hundred tables, equations, drawings, and images, and handy, easy-to-use indices, facilitating easy accessibility to every subject.

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Example text

For example, a sample obtained by crystallization from solvent exhibited two endothermic events (at 160 and 180°C) by DSC analysis (Fig. 39). On initial HSM examination of bulk crystalline material no change was observed at 160°C, but the event at 180°C was shown to be melting. Cooling of the HSM sample afforded a crystalline film which, reheated on the hot stage, revealed a solid–solid transition at about 160°C. The transition was observed as a change in birefringence colors under crossed polarizers, and was found to be spontaneous and rapid in both directions.

However, once a seed of the more stable form arises, crystallization of that stable form can begin and all of the existing metastable material can, and eventually will, be converted to the stable material. Once a given polymorphic form has crystallized, its seeds are everywhere, and it can be difficult to remake original forms. An example of problems caused by an appearing polymorph may be found in the case of Abbott Laboratories’ protease inhibitor ritonavir (Fig. 34) (50). This compound was discovered, developed, manufactured, and marketed over a span of several years, so countless solid samples were generated during that time.

14), dry hydrogen chloride or hydrogen bromide gas was bubbled into anhydrous ether solutions of the lidocaine base (16). Chloride and lactate salts of the cholinesterase reactivator N-methyl pyridinium-2-aldoxime (Fig. 15) were prepared using ion-exchange resins (19). Complex salts of the diuretic triamterene (Fig. 16) were produced from various acids (hydrochloric, nitric, sulfuric, phosphoric, and acetic) using the phase-solubility technique (20). Profiles of apparent solubility as a function of pH detected complex salt species containing both protonated and unprotonated triamterene.

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