Development of validated stability-indicating assay methods--critical review.

  title={Development of validated stability-indicating assay methods--critical review.},
  author={Monika Bakshi and Saranjit Singh},
  journal={Journal of pharmaceutical and biomedical analysis},
  volume={28 6},
This write-up provides a review on the development of validated stability-indicating assay methods (SIAMs) for drug substances and products. The shortcomings of reported methods with respect to regulatory requirements are highlighted. A systematic approach for the development of stability-indicating methods is discussed. Critical issues related to development of SIAMs, such as separation of all degradation products, establishment of mass balance, stress testing of formulations, development of… CONTINUE READING

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