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          • Does a monograph on a medicinal product containing a chemically defined active substance apply to all strengths and formulations?
          • What principles apply to disintegration tests described in medicinal product monographs?
          • Why can the limit for total impurities in a monograph on medicinal product containing a chemically defined active substance be lower than the limit for total impurities in the corresponding active substance monograph?
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  3. EDQM FAQs
  4. EDQM FAQs in English
  5. EUROPEAN PHARMACOPOEIA & INTERNATIONAL HARMONISATION
  6. General Chapters and Monographs
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MEDICINAL PRODUCT MONOGRAPHS

  • Created by MONTARD Laurence on May 03, 2023

  • Does a monograph on a medicinal product containing a chemically defined active substance apply to all strengths and formulations?
  • What principles apply to disintegration tests described in medicinal product monographs?
  • Why can the limit for total impurities in a monograph on medicinal product containing a chemically defined active substance be lower than the limit for total impurities in the corresponding active substance monograph?

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