alexa Common Problems in Stress Testing of Pharmaceutical Preparations

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Common Problems in Stress Testing of Pharmaceutical Preparations

Stress testing which is also called force degradation study is performed to evaluate the inherent stability of the drug substances and drug products and also to reveal the main degradation pathways as well as to introduce a stability indicating method. According to ICH guidelines identification of the degradation products are only limited to those which are similarly produced in accelerated conditions. Stress conditions are defined as oxidation, hydrolysis at various pH values and photolysis reactions [1-3] In the available guidelines for performing the stress tests, the details such as the type of suitable stresses and the amount of total degradation indicating the end of the experiment has not been mentioned. On the other hand the available information in the literature is contrary [2,4-10] but there is a very useful review in this area by Singh et al.

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