title: Multivariate control charts based on net analyte signal (NAS) and Raman spectroscopy for quality control of carbamazepine.
abstract: Raman spectroscopy and control charts based on the net analyte signal (NAS) were applied to polymorphic characterization of carbamazepine. Carbamazepine presents four polymorphic forms: I-IV (dihydrate). X-ray powder diffraction was used as a reference technique. The control charts were built generating three charts: the NAS chart that corresponds to the analyte of interest (form III in this case), the interference chart that corresponds to the contribution of other compounds in the sample and the residual chart that corresponds to nonsystematic variations. For each chart, statistical limits were developed using samples within the quality specifications. It was possible to identify the different polymorphic forms of carbamazepine present in pharmaceutical formulations. Thus, an alternative method for the quality monitoring of the carbamazepine polymorphic forms after the crystallization process is presented.
authors.affiliation: Institute of Chemistry, University of Campinas-UNICAMP, P.O. Box 6154, 13083-970 Campinas, SP, Brazil.
authors.forename: Werickson Fortunato de Carvalho
authors.initials: WF
authors.lastname: Rocha
authors.forename: Ronei Jesus
authors.initials: RJ
authors.lastname: Poppi
mesh_terms: D018712:Analgesics, Non-Narcotic / Q000737:chemistry*; D002220:Carbamazepine / Q000737:chemistry*; D003460:Crystallization; D015999:Multivariate Analysis; D033362:Powder Diffraction; D011786:Quality Control; D013059:Spectrum Analysis, Raman / Q000379:methods*; D014961:X-Ray Diffraction
chemical_list: D018712:Analgesics, Non-Narcotic; D002220:Carbamazepine