forced degradation study
Forced degradation study, also known as stress testing, is a process
undertaken during the development of a pharmaceutical drug or a
new formulation to understand the stability and degradation
behavior of the drug under different stress conditions.
The primary objective of a forced degradation study is to identify
and characterize potential degradation pathways and products of
the drug substance or formulation that may occur under different
stress conditions, such as heat, light, humidity, oxidation, and
acid/base hydrolysis.
This study helps in establishing the stability-indicating capability
of the analytical methods used to analyze the drug substance or
formulation. It also provides information on the critical
degradation pathways and any degradation products that may be
formed.
Various stress conditions are applied to the drug substance or
formulation, and the samples are analyzed using different
analytical techniques, such as chromatography, spectroscopy, and
mass spectrometry, to identify and quantify the degradation
products.
The results of a forced degradation study aid in determining the
degradation pathways, as well as the potential impact of
environmental factors on the stability and safety of the drug. This
information is crucial in designing appropriate storage conditions,
packaging, and shelf-life estimates for the drug.
Overall, forced degradation studies help ensure the quality, safety,
and efficacy of pharmaceutical products by providing valuable
information on degradation pathways and degradation products
that may arise during the drug's lifecycle.
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