Alaa Elkazak, Msc., RAC-Drugs, PMP, CMQ-OE’s Post

View profile for Alaa Elkazak, Msc., RAC-Drugs, PMP, CMQ-OE

Pharmaceutical Excellence: Regulatory, Projects, & Programs

🚨 Pharma Professionals, Are Your Excipients Secretly Sabotaging Drug Safety? 💊 Nitrosamines are more than just a regulatory buzzword—they’re a persistent threat to drug product safety. And the culprit? Often it's excipients with hidden nitrite levels. 🧪 To inhibit the nitrosamines formation reaction, you either: 1. Control the reaction itself by pH modification or adding antioxidants 2. Limit one of the two reactants: amines or nitrites 👉 Here, we’ll focus on the “nitrite” part—especially the hidden levels in excipients. In this quick carousel, I break down: ✅ The real nitrosamine risk behind "safe" excipients ✅ Why low-nitrite excipient grades matter now more than ever ✅ Leading suppliers offering compliant solutions ✅ Smart questions every manufacturer should be asking their suppliers 🔍 “You can check it yourself.” 📲 Swipe through the slides to learn how to future-proof your formulations. 👉 If you’re working in formulation, QA/QC, or regulatory affairs—this is a must-read. ✋Do you know other suppliers/ brands which are nitrite-controlled? Please mention them in the comments to update the list so that all of us get full benefits of alternatives of high quality🦾 📢 Tag a colleague who should see this, and share if you found it useful. Let’s keep raising the bar for patient safety. IFF Asahi Kasei DFE Pharma NITIKA PHARMACEUTICAL SPECIALITIES PVT LTD BASF MEGGLE Excipients

Christos Charitos

Senior manager of Analytical Development Lab of RnD at Elpen Pharmaceutical Co. Inc.

5mo

excellent, thanks a lot Alaa!!

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