Publications by authors named "David Baertschi"
Article Synopsis
- The ICH Q1B guidance outlines the necessary protocols for conducting photostability testing of pharmaceutical drugs, focusing on aspects like manufacturing, packaging, and storage.
- Previous papers addressed photostability testing for injectable and topical drug products, highlighting a gap in guidance for oral drug formulations.
- This third paper expands on the topic by detailing experimental approaches that simulate extreme photoexposure conditions using ICH-defined light sources to ensure the safety and effectiveness of photosensitive oral medications.
The availability of high performance liquid chromatography (HPLC) columns capable of operation at pH values up to 12 has allowed a greater selectivity space to be explored for method development in pharmaceutical analysis. Ammonium hydroxide is of particular value in the mobile phase because it is compatible with direct interfacing to electrospray mass spectrometers. This paper reports an unexpected N-nitrosation reaction that occurs with analytes containing primary and secondary amines when ammonium hydroxide is used to achieve the high pH and acetonitrile is used as the organic modifier.
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