Forced Degradation Studies for Drug Substances & Drug Products- Scientific Considerations
Forced degradation or stress testing is commenced to determine specificity when developing stability-indicating methods, particularly when little information is available about potential degradation products. These studies also provide information about the degradation pathways and degradation products that could form during the storage of drugs substances and drug products. Forced degradation studies may help facilitate pharmaceutical development at various stages as well in areas such as formulation development, manufacturing, and packaging, and stability studies in which knowledge of chemical behavior can be used to improve a drug product.
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