Identification of carbamazepine polymorphs in raw material samples used in the manufacture of products marketed in Argentina
DOI:
https://doi.org/10.62035/rca.6.74Keywords:
carbamazepine, polymorphic crystals, spectroscopy, Fourier transform infrared, calorimetry, differential scanningAbstract
The phenomenon of polymorphism in active pharmaceutical ingredients is of particular relevance to human health, as it is directly related to the bioavailability of the drug in the body. It is essential to study and know their possible crystalline transformations in order to control or prevent them. Carbamazepine is an antiepileptic drug with a narrow therapeutic range. Its various crystalline forms (polymorphs) result in differences in dissolution behavior, thus altering its pharmacokinetics and pharmacodynamics, and consequently, its pharmacological effect. Five anhydrous polymorphic forms of carbamazepine are currently known, but only form III is suitable for use in pharmaceutical formulations. In this study, the polymorphs present in different batches of carbamazepine raw material, used in the manufacture of products currently available on the national market, were analyzed using Differential Scanning Calorimetry (DSC), Fourier Transform Infrared Spectroscopy (FTIR), and Hot Stage Optical Microscopy.
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Copyright (c) 2025 Melina Dal Mas, Eliana Pasquini, Ana Pointner, Marina Saavedra, Valeria Soria, Marianela Polanco Jaymes, María Vallese, Verónica Llauró
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