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Published on: February 3, 2023
Estimation and characterisation of budesonide tablets impurities
Patrizia Ferraboschi1, Vittorio Bertacche, Isabella Maccone
1Dipartimento di Chimica, Biochimica e Biotecnologie per la Medicina, Università di Milano-Via Saldini, 50-20133 Milano, Italy. patrizia.ferraboschi@unimi.it
Unknown impurities were found in budesonide tablets after three years of storage. Chemical and spectroscopic methods were used to identify these novel budesonide degradation products.
Area of Science:
- Pharmaceutical Chemistry
- Analytical Chemistry
Background:
- Budesonide is an anti-inflammatory corticosteroid.
- Stability studies are crucial for pharmaceutical product quality.
Purpose of the Study:
- To identify unknown impurities in budesonide tablets stored under specific conditions.
- To characterize budesonide degradation products not listed in the European Pharmacopoeia.
Main Methods:
- Storage of budesonide tablets at 25°C and 60% relative humidity for 3 years.
- Utilized chemical and spectroscopic analytical techniques for impurity identification.
Main Results:
- Several unknown impurities were detected in the aged budesonide tablet samples.
- These impurities were not previously reported in the European Pharmacopoeia.
Conclusions:
- Long-term storage of budesonide tablets can lead to the formation of novel degradation products.
- Analytical methods are essential for detecting and identifying impurities in pharmaceutical formulations.
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