Impurity Profiling in Pharmaceuticals

Описание: In this video, we delve into the crucial topic of Impurity Profiling in Pharmaceuticals. Impurity profiling ensures the safety, quality, and efficacy of drug substances and products by identifying, characterizing, and quantifying unwanted chemicals that may arise during manufacturing or storage.

🔍 What You'll Learn:

What are impurities and why they matter in drug development.
The different types of impurities: organic, inorganic, and residual solvents.
The importance of impurity profiling for patient safety and regulatory compliance.
Key guidelines from ICH (Q3A, Q3B, Q3C, M7) and their significance.
Analytical methods used for impurity analysis, including HPLC, GC, and Mass Spectrometry.
Challenges and recent advances in impurity profiling.
The role of impurity profiling across the drug development process, from preclinical stages to post-approval monitoring.
🧪 Why Is Impurity Profiling Important? Understanding and controlling impurities is essential to meet regulatory standards and to ensure that pharmaceutical products are safe and effective for patients. This video is ideal for pharmaceutical professionals, students, and academicians looking to deepen their understanding of impurity management.

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