Many impurities can be produced during shipping or shelf life of pharmaceutical products. Therefore, to perform stability studies, it is important to assess, predict and ensure the safety of the product. Sample pack stability, marketing pack stability, formulation stability and delivery pack stability are all considered for drug product stability and it is important to ensure that each should be aware of the importance of stability. .
Gout impurity is about determining how many potential impurities are actually formed in the manufacturing process and which end up under storage conditions. Throughout the development phase, this information can be used for processing to be modified in an attempt to reduce impurities.
Additionally, stability characteristic information can be used for drug substance packaging, storage, and environmental conditions to reduce or eliminate unacceptable degradation.
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