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

  ..

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