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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
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Last update 4 October 2019