Nitrosamine Impurities, NDMA & NDSRIs in Hindi | Why Drug Recalls? FDA & EMA Guidelines | QC QA R&D
Автор: Pharma QC Guide
Загружено: 2026-01-08
Просмотров: 231
Описание:
Nitrosamine Impurities, NDMA & NDSRIs in Hindi | Why Drug Recalls? FDA & EMA Guidelines | QC QA R&D
👉Why are major medicines being pulled from the market? In this video, we explain the science behind Nitrosamine impurities, the rise of NDSRIs, and how the pharmaceutical industry controls these risks. This is a complete guide for QC, QA, and R&D professionals and Pharmacy students.
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📌 What you will learn 📌
In this video, we cover the Nitrosamine reaction mechanism in detail to help you understand how these impurities form in drug products. We explain what NDMA and NDSRIs (Nitrosamine Drug Substance Related Impurities) are and provide a step-by-step guide on how to conduct a Nitrosamine risk assessment based on current FDA & EMA guidelines.
If you are looking for a complete explanation of Nitrosamine Impurities in Hindi, this video covers everything from Nitrosamine formation to practical control strategies for QC, QA, and R&D professionals.
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📥 RESOURCES 📥
👇Download PDF Notes👇
https://pharmaqc.web.app/nitrosamine....
⚡LinkedIn⚡
/ mehul-prajapati-575140271
🕒 VIDEO CHAPTERS:
00:00 - Interoduction
00:53 - Topics covered
01:44 - What are Nitrosamine Impurities?
03:19 - How Nitrosamines are Formed
03:56 - Structure of NDMA, NMBA and NDEA
04:13 - What is NDMA?
05:30 - Understanding NDSRIs
05:58 - Source of Nitrosamines
06:17 - Control Strategies
06:36 - Why Drug Recalls happen?
06:56 - FDA, EMA Guidelines & AI Limit
07:49 - How to Visit my Official Website
🎬 Production Credits
🔬 Research : Gemini AI
🎨 Visuals & Templates: Canva
🎬 Editing & Effects: CapCut
🧪 Chemical Structures: Created using Marvin JS by Chemaxon (https://www.chemaxon.com)
#NitrosamineImpurities #NDSRIs #NDMA
#PharmaQC #DrugSafety
#NitrosamineImpuritiesHindi
Mehul Prajapati
QC Officer I #Pharmaqcguide
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