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
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.
Different sources of iron.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.