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Evaluation of effects of tableting variables on drug stability: a case study with gabapentin

  • In: D5 - Solving tableting problems on Tuesday, 6 September 2011, 09:00-12:00
  • At: Hyderabad (India) (2011)
  • Type: Presentation
  • By: KHAN, Mansoor (FDA, Rockville, United States of America)
  • Abstract:

    Drug product stability is often provided by sponsors at accelerated conditions of temperature and humidity to obtain a tentative expiration date at ambient conditions. It works very well for most solid oral products. This expiration date based on predictions is then backed by stability at ambient conditions. In some cases, though, the


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Last update 4 October 2019

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