Forced degradation is the study of the chemical stability of a new drug product and drug substance at the condition of more severe than accelerated condition. The forced degradation study illustrates the chemical stability of the drug molecules which further facilitates the development of stable formulation with suitable storage conditions. Regulatory guideline USFDA, ICH, EMA, ANVISA demonstrate certain degradation conditions like light, oxidation, heat, acidic, basic, hydrolysis effect on drug product and drug substance due to these condition stability of the drug product and drug substance affect and reduce their stability so the guideline suggests to performed stability study on new drug product and drug substance. ICH Q1A, Q1B, Q1C, Q1D, Q1E and Q1F are the example of the stability testing study which is also called as forced degradation study of the product molecules. Stability indicating a method to develop forced degradation of the drug product and drug substance. This review gives information about current strategic approaches and trends in forced degradation studies.
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