All pharmaceutical packaging systems need to comply with performance requirements to guarantee the integrity and safety of the contained drug throughout its lifecycle, from manufacturing to distribution and ultimately to the end-user. Monitoring spectral transmission helps ensure that the container provides adequate protection against light-induced degradation. For this reason, analytical methods and acceptance criteria are specified in the United States Pharmacopoeia (USP) chapters <660>1 and <671>2 to determine the spectral transmission of pharmaceutical glass and plastic containers, respectively.
The application note describes the use of the LAMBDA 365+ UV/Vis spectrophotometer with an integrating sphere to assess the spectral transmission of pharmaceutical containers, in accordance with USP Guidelines <660> and <671>. It details the methodology for evaluating packaging systems for oral drugs, specifying the preparation and analysis process.