US FDA Suggests Adding Antioxidants To Drug Formulations To Mitigate Nitrosamine Risks
Executive Summary
Agency recommends “mitigation strategies” also including designing formulations that incorporate excipients such as sodium carbonate which modify the micro-environment to neutral or basic pH.
You may also be interested in...
Federal Preemption Strikes California Prop 65 Complaint Against Generic OTC Ranitidine Firms
Whether California court finds Zantac, when marketed containing ranitidine, should have had a Prop 65 label warning could be influenced by dismissal in federal court of class action complaints due to faulty research behind claims that ranitidine causes a carcinogenic substance to form post-production.
USP Nitrosamine Impurities Chapter Reflects Coordination With EU As Well US Agencies
The USP’s general chapter on nitrosamine impurities provides guidance on assessing risks and testing levels of the carcinogens in pharmaceuticals.
US FDA Won't Budge On Nitrosamines Compliance Despite Complaints Of Possible Drug Shortages
Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.