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ICP-MS, A POWERFUL ANALYTICAL TECHNIQUE FOR FULL COMPLIANCE WITH ICH Q3D FOR ELEMENTAL IMPURITIES

  • At: 2019 FIP Congress in AbuDhabi (United Arab Emirates)
  • Type: Poster
  • By: DIAS, Clarisse (INFOSAUDE-LEF (ANF), Pharmacy Support Department- Pharmacy Compounding, Portugal)
  • Co-author(s): Fátima Carvalho: Technical and Executive Director, INFOSAUDE-LEF (ANF), OEIRAS, Portugal
    Duarte Santos: ANF Board Director, ANF, National Association of Pharmacies, Lisbon, Portugal
    Rita Lopes: Analytical Development & Validation, INFOSAUDE-LEF (ANF), OEIRAS, Portugal
    Tania Rito: Quality Assurance, INFOSAUDE-LEF (ANF), OEIRAS, Portugal
    Ana Brízio: Quality Control & Stability, INFOSAUDE-LEF (ANF), OEIRAS, Portugal
    Fábio Brito: Analytical Development & Validation, INFOSAUDE-LEF (ANF), OEIRAS, Portugal
    Paula Rato: Analytical Development & Validation, INFOSAUDE-LEF (ANF), OEIRAS, Portugal
  • Abstract:

    Background

    In the last few years, heavy metal regulations have been implemented in the Pharmaceutical Industry to control the presence of elemental impurities in a pharmaceutical product, which can enhance toxicity and potentially lead to adverse effects in patients.

    The need for full compliance within the ICH Q3D Guideline led us to develop and

    ..

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Last update 21 September 2019

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