Tuesday, 3 May 2011

Help on: Forced Degradation Studies

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Question:
What is meant by forced degradation studies?
Answer:
In a forced degradation study a molecule is subjected to extremes of heat, humidity, pH, light, etc. so that the molecule degrades. This study is commonly performed for pharmaceutical active pharmaceutical ingredients and formulations and is typically done for one of two reasons:

1. It provides information on the possible degradation pathways of the molecule and thus an assessment of its stability under different types of conditions. The information obtained is usually included in the marketing dossier for the drug.

2. It provides samples which can be used to develop a stability indicating method, i.e. a method which can detect and quantify degradation products. This method is used to assess shelf life during stability studies.

A problem with forced degradation studies is that the extreme conditions used may not be representative of the degradation under ‘normal’ conditions. For this reason the aim is to degrade the molecule of interest by no more than 10%.

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