by Dr. Yashashwini Reddy | Aug 8, 2025
1. Principle of HPLC High-Performance Liquid Chromatography (HPLC) works on the principle of separation by differential partitioning of sample components between a mobile phase (liquid) and a stationary phase (solid adsorbent material inside a column). Components with...
by Dr. Yashashwini Reddy | Aug 8, 2025
Resolving API Impurity Issues in Drug Development 1. Understanding the Issue In drug development, impurities in the Active Pharmaceutical Ingredient (API) can arise from: Starting materials or intermediates (process-related impurities) By-products from synthesis steps...
by Dr. Yashashwini Reddy | Aug 8, 2025
1. Principle of Gas Chromatography Gas Chromatography is based on the principle of partitioning of components between a mobile phase (inert carrier gas) and a stationary phase (solid or liquid supported on a solid). Mobile phase: An inert gas (e.g., helium, nitrogen,...
by Dr. Yashashwini Reddy | Jun 9, 2025
Importance of Validation in Pharmaceuticals Validation in the pharmaceutical industry is a documented process that proves that a system, equipment, method, or process consistently produces a result meeting predetermined quality standards. It is a fundamental part of...
by Dr. Yashashwini Reddy | May 3, 2025
The pharmaceutical industry is governed by strict regulatory standards and demands exceptional levels of quality and safety. Integrating Six Sigma principles into pharmaceutical operations can significantly improve process efficiency, compliance with regulatory...
