• 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}
}
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… 

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Copyright: © 2014 Monajjemzadeh F, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and

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The regulatory aspects for development of stability indicating methods are reviewed and force degradation is required to demonstrate the specificity when developing SIMs and for this reason, it should be perform prior to implementing the stability studies.

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