Budesonide is the 16alpha,17alpha-acetal of 16alpha-hydroxyprednisolone with n-butyraldehyde, endowed with anti-inflammatory activity. In a sample of budesonide tablets, kept for three years at 25 °C and 60% RH unknown impurities, not reported in European Pharmacopoiea, were present. Their identification was achieved by means of chemical and spectroscopic methods.
Estimation and characterisation of budesonide tablets impurities / P. Ferraboschi, V. Bertacche, I. Maccone, E. Pini, L. Ragonesi, A. Venturini, R. Stradi. - In: JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS. - ISSN 0731-7085. - 47:3(2008 Jul 15), pp. 636-640. [10.1016/j.jpba.2008.01.050]
Estimation and characterisation of budesonide tablets impurities
P. Ferraboschi;V. Bertacche;E. Pini;L. Ragonesi;R. Stradi
2008
Abstract
Budesonide is the 16alpha,17alpha-acetal of 16alpha-hydroxyprednisolone with n-butyraldehyde, endowed with anti-inflammatory activity. In a sample of budesonide tablets, kept for three years at 25 °C and 60% RH unknown impurities, not reported in European Pharmacopoiea, were present. Their identification was achieved by means of chemical and spectroscopic methods.
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