An Extensive Comprehension of Forced Degradation Studies of New Drug Substances and Products
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Abstract
Forced degradation tests are a method used in the pharmaceutical industry to assess the stability of medication samples. Stress examination of degradation products is beneficial in determining the pathways of degradation as well as designing and testing appropriate analytical techniques. Forced degradation experiments reveal chemical behavior of the molecule, which aids in formulation & package creation. According to the studies, the majority of researchers and reviewers claim to use ICH recommendations, Q1A-Q1F, for the degradation analysis and impurity profiling of drug substances & drug products. A variety of spectroscopic and chromatographic techniques like as UV spectroscopy, RP- HPLC, Gas Chromatography, and others may be used for regular analysis of pharmacological compounds and products. Forced degradation studies of medicinal compounds and products have found a significant application for hyphenated approaches. The current research also provides significant insights into the stability indicating assay techniques and their importance in determining medication stability. The study also discusses the role of excipients in the deterioration of pharmaceuticals.
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