Forced Degradation Study in Pharmaceutical Stability

 Forced Degradation Study in Pharmaceutical Stability

Forced degradation is also known as stress testing and a drug is degraded forcefully by applying artificial methods. It is a useful tool to predict the stability of any Active Pharmaceutical Ingredient (API) or formulation product. It helps to know about the impurities developed during the storage of drug products in various environmental conditions.

A drug substance or product is considered stable if it shows its stability for two years at 30 ±2⁰C & 65 ±5% RH and six months at 40 ±2⁰C & 75 ±5% RH 

i.e. ICH storage conditions for stability testing for pharmaceutcal products. 

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Forced degradation study depends upon the product and the type of dosage form. Solid, liquid and injection dosage forms have different procedures of the stress study. ICH Q1B guideline provides guidance only on the photostability of the product.

According to the FDA forced degradation study is performed during the third phase of the regulatory submission of the drug substance or drug formulation product. Limit of degradation is 5-20%. More than 20% degradation is abnormal and should be investigated.

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