Estimation and characterisation of budesonide tablets impurities

  • J Pharm Biomed Anal. 2008 Jul 15;47(3):636-40. doi: 10.1016/j.jpba.2008.01.050.
Patrizia Ferraboschi  1 ,  Vittorio Bertacche ,  Isabella Maccone ,  Elena Pini ,  Laura Ragonesi ,  Alessio Venturini ,  Riccardo Stradi
Affiliations
  • 1. Dipartimento di Chimica, Biochimica e Biotecnologie per la Medicina, Università di Milano-Via Saldini, 50-20133 Milano, Italy. [email protected]
PMID: 18367362 DOI: 10.1016/j.jpba.2008.01.050
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 3 years at 25 degrees 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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