Estimation and characterisation of budesonide tablets impurities.
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.
Ferraboschi
Patrizia
P
Dipartimento di Chimica, Biochimica e Biotecnologie per la Medicina, Università di Milano-Via Saldini, 50-20133 Milano, Italy. patrizia.ferraboschi@unimi.it
Bertacche
Vittorio
V
Maccone
Isabella
I
Pini
Elena
E
Ragonesi
Laura
L
Venturini
Alessio
A
Stradi
Riccardo
R
D019819:Budesonide / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D013607:Tablets
D013607:Tablets; D019819:Budesonide