Forced Degradation of Ibuprofen in Bulk Drug and Tablets and Determination of Specificity, Selectivity, and the Stability-Indicating Nature of the USP Ibuprofen Assay Method

ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products.

In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.

The shift toward personalized medicines poses new challenges in cleanroom protocols.

The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.

The CytoFLEX mosaic Spectral Detection Module offers up to 88 channels for detection.

The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.