Application Note: Headspace Oxygen Measurement In Vials And Ampoules With The Orbisphere PharmaPack In The Pharmaceutical Industry
Source: Beckman Coulter Life Sciences
By Hach Ultra Analytics
Small volume parenteral (SVP) solutions are packaged in different ways depending on their intended use: as heat-sealed ampoules, vials sealed with a rubber closure, or prefilled syringes.
In some cases oxygen may have negative effects on the product such as:
- oxidative degradation of the active drug substance
- decrease drug potency and reduce product shelf life
- product discoloration, changes in dissolution rate and profile, precipitation
- generation of foul odors and flavors
- generation of adverse pharmacological properties, including those associated with toxicity or negative side effects
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