Nitrosamines in Pharmaceuticals: Formation, Risks, and Detection Methods Explained

Описание: 🔬 Welcome to ADVENT Chembio’s Masterclass on Nitrosamines!

In today’s video, Dr. Mohanty dives into the world of Nitrosamines—small chemical compounds that have caused big concerns in the pharmaceutical and chemical industries due to their potential health risks. We explore their formation, impact on drug safety, and how ADVENT is helping the industry navigate these challenges.

📌 What You Will Learn:

What Are Nitrosamines?
Nitrosamines are a class of compounds with a nitroso group attached to an amine. Many Nitrosamines are carcinogenic and mutagenic, making them a serious health concern, even at very low levels. Dr. Mohanty covers examples like NDMA and NDEA, which have been linked to recalls in pharmaceuticals.

How Do Nitrosamines Form?
Nitrosamines form unintentionally as by-products during chemical reactions, especially when nitrites react with amines in acidic environments or high temperatures. Dr. Mohanty explains how Nitrosamines form in pharmaceutical processes, cross-contamination, and raw material issues.

The Evolution of Nitrosamine Detection
The Nitrosamine story began in July 2018, when NDMA was found in Valsartan, a commonly used antihypertensive drug, triggering global recalls. Since then, more Nitrosamines have been discovered in various drug products, causing pharmaceutical companies to reassess their processes. Dr. Mohanty walks you through how regulatory bodies like the FDA and EMA have addressed these concerns with updated guidelines.

Risks and Concerns with Nitrosamines
Nitrosamines not only pose health risks but also have led to supply chain disruptions and economic losses for manufacturers due to product recalls and regulatory penalties. Learn how these challenges have reshaped pharmaceutical safety and drug quality.

Detection and Analytical Methods
Detecting Nitrosamines at ultra-trace levels requires sophisticated techniques like GC-MS, LC-MS, and HPLC. Dr. Mohanty covers how these methods are used to accurately identify and quantify Nitrosamines in drug products.

ADVENT’s Role
ADVENT has developed high-purity Nitrosamine working standards for the quantitative determination of these impurities in pharmaceutical products. These standards are available in ready stock and customizable packs for your specific needs, ensuring accurate testing and compliance.

📌 Subscribe to ADVENT Chembio’s channel for more insightful masterclasses on pharmaceutical quality, safety, and testing solutions.

Also Follow us on:
Instagram: https://www.instagram.com/adventchem?...
Facebook: https://www.facebook.com/profile.php?...
Linkedin: https://www.linkedin.com/company/adve...