To support new drug product licencing our client required the identification of degradation products produced during the forced degradation of the Active Pharmaceutical Ingredients (APIs) in their product. The sample was force degraded and, where possible, the degradation products identified using high-resolution mass spectrometry. Quantitative methods were then developed and validated to current ICH guidelines to allow the degradation products to be monitored during the stability program.
Our client required an alternative route to an anti-fungal drug as their current synthetic scheme had a final stage of only 17% yield. Following a literature survey we devised a new synthetic scheme that was developed in the laboratory to give a 64% yield in fewer stages using more environmentally friendly conditions and reagents.
Development of a Quality Control Method for Herbal Extracts