• Corpus ID: 54644738

Guidance on Conduct of Stress Tests to Determine Inherent Stability of Drugs

@inproceedings{Singh2000GuidanceOC,
  title={Guidance on Conduct of Stress Tests to Determine Inherent Stability of Drugs},
  author={Saranjit Singh and Monika Bakshi},
  year={2000}
}

• Saranjit Singh, M. Bakshi
• Published 2000
• Materials Science

he International Conference on Harmonization (ICH) guideline entitled ‘Stability Testing of New Drug Substances and Products’ (Q1A) requires that stress testing be carried out to elucidate the inherent stability characteristics of the active substance (1). It suggests that the degradation products that are formed under a variety of conditions should be identified and degradation pathways established. It is stated that the testing should include the effect of temperature, humidity where appropriate; oxidation, photolysis and susceptibility to hydrolysis across a wide range of pH values. In the guideline, the study of the effect of temperature is suggested to be done in 10 C increments above the accelerated temperature test condition (e.g. 50 C, 60 C, etc.) and that of the humidity at a level of 75 percent or greater. No details are, however, provided for the study of oxidation, photolysis and hydrolysis at different pH values. In the absence of guidance, difficulties are faced by practitioners to decide on the stress conditions to be employed for a new drug at the time of initiation of forced decomposition studies. In this write-up the authors propose a classification system for categorization of drugs based on their inherent stability behaviour. Flow charts have been drawn that are suggested to be followed for determining the stress test conditions for hydrolysis (under neutral, acid and alkaline conditions), oxidation, and photolysis.