2022
DOI: 10.1093/chromsci/bmac070
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Mini Review on Forced Degradation Studies on Anti-Epileptic Drugs and Beyond

Abstract: In this review on the forced degradation studies on anti-epileptic drugs and the development of validated stability-indicating assay methods for drug substances and products at a condition more severe than accelerated condition (i.e. 40 ± 2°C, 75 ± 5% relative humidity), the drug substance and drug product undergo degradation is known as forced or stress degradation. To know about the impurities developed during the storage of drug products in various environmental conditions. The limit of degradation allowabl… Show more

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“…Forced degradation solutions were prepared by subjecting STHCl to a range of stress conditions in line with the International Conference on Harmonization (ICH) guideline Q1A(R2) [28]. Briefly, STHCl solutions were subjected to hydrolytic (acidic, alkaline, and neutral), thermal, photolytic, and oxidative degradation [29], as follows: acidic hydrolysis (1 M HCl, 37 • C, 30 min), alkaline hydrolysis (1 M NaOH, 37 • C, 4 min), oxidation (30% H 2 O 2 , 37 • C, 30 min), thermal degradation in a heated water bath (H 2 O, 100 • C, 30 min), photolytic degradation (4500 Lx, 16 d), and neutralizing the acidic and alkaline samples prior to dilution [30].…”
Section: Forced Degradation and Long-term Studiesmentioning
confidence: 99%
“…Forced degradation solutions were prepared by subjecting STHCl to a range of stress conditions in line with the International Conference on Harmonization (ICH) guideline Q1A(R2) [28]. Briefly, STHCl solutions were subjected to hydrolytic (acidic, alkaline, and neutral), thermal, photolytic, and oxidative degradation [29], as follows: acidic hydrolysis (1 M HCl, 37 • C, 30 min), alkaline hydrolysis (1 M NaOH, 37 • C, 4 min), oxidation (30% H 2 O 2 , 37 • C, 30 min), thermal degradation in a heated water bath (H 2 O, 100 • C, 30 min), photolytic degradation (4500 Lx, 16 d), and neutralizing the acidic and alkaline samples prior to dilution [30].…”
Section: Forced Degradation and Long-term Studiesmentioning
confidence: 99%