A stability study that provides an opportunity to extend the product shelf life, by optimising the formulation and/or product packaging.
This case study describes how a manufacturer of a syringe product received complaints about discoloured product that was nearing the end of shelf life. A root cause investigation was started and product syringes were put on stability. The headspace oxygen levels were monitored over time. Laser-based headspace analysis is a useful tool to check package integrity and for the presence of reactive headspace gases that can degrade the formulation.
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