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IMPACT OF KEY STARTING MATERIAL ON REGULATORY COMPLIANCE: AN EVALUATION OF FERRIC AMMOINIUM CITRATE

  • At: 2019 FIP Congress in AbuDhabi (United Arab Emirates)
  • Type: Presentation
  • By: JALUNDHWALA, Forum (Shreenath Chemicals, Quality Assurance, India)
  • Co-author(s): Forum Janak Jalundhwala: Shreenath Chemicals, Boisar, India;, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM's, NMIMS, Mumbai, India
    Vaishali Londhe: Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM's NMIMS, Mumbai, India
  • Abstract:

    Background

    Current regulatory environment requires a paradigm shift from product knowledge to process knowledge, making it essential to evaluate the synthesizing process of drug right from the  key starting materials (KSM). Ferric ammonium citrate (FAC), a hematinic agent, is synthesized using different KSM.

    Methods

    Different sources of iron (KSM in

    ..

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Last update 21 September 2019

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