Ramos Rivera, Zainette

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    In situ studies of sulfamerazine and carbamazepine crystallization
    (2005) Ramos Rivera, Zainette; Romañach, Rodolfo J.; College of Arts and Sciencies - Sciences; López, Gustavo E.; Ríos-Steiner, Jorge L.; Department of Chemistry; Hernández, Arturo
    The phenomenon of polymorphism in active pharmaceutical ingredients (API) has become an important area of study in the pharmaceutical industry. Polymorphs of a given substance can exhibit different properties. These properties can affect both the bulk chemical properties and pharmaceutical performance. As a result the control and monitoring of crystallization is one of the most important stages in the pharmaceutical manufacturing process. This research project investigated the influence of solvents in the crystallization of two active pharmaceutical ingredients: sulfamerazine (Form I) and carbamazepine (Form III). For sulfamerazine, the experimental approaches to achieve the supersaturated solutions involve two methods: the use of temperature dependence on solubility and the introduction of some other solvent to reduce the solubility of the solution. Seeding a saturated solution was also employed to observe the interaction of solvent in the crystallization process. For carbamazepine only the temperature dependence of solubility was employed. Fiber optics near infrared (NIR) and Raman spectroscopy were used for in situ monitoring of crystallization process. The crystallized solid phase was identified using XRD, SEM and Raman microscopy. The results show that solvents affect the crystallization process of the polymorph. However, the studies did not establish prior to precipitation, any preference for a particular crystal form, when using the band shift of solvent as criteria.