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publicationDate 2009-05-29-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber FR-2924223-A1
titleOfInvention PROCESS FOR DETERMINING THE POLYMORPH PURITY OF MANIDIPINE DICHLORHYDRATE.
abstract A method for determining the polymorphic purity of beta polymorphic manidipine dihydrochloride in a pharmaceutical tablet using Raman spectral information, comprising the steps of: i) preparing a series of known samples, each of known samples comprising a quantity of polymorph beta and a quantity of polymorph alpha, in which, in each of the known samples, the total amount of the compounds remains the same while their ratio is modified, ii) acquire the Raman spectra of the various known samples, iii) select one or more wavelength signals for each form so that the spectral differences that appear in each of the known samples are essentially appreciable and so that the signals of the excipients do not interfere iv) perform a statistical analysis of the spectral data of the series of known samples, v) collect data es spectrum of a sample comprising the polymorphic manidipine dihydrochloride beta with an unknown polymorph purity; andvi) calculating the polymorphic purity of the beta polymorph.
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