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 | Apr 17, 2025
1. What is GC-MS and how does it work? Answer: GC-MS combines gas chromatography (GC) for separation of compounds and mass spectrometry (MS) for identification and quantification. The sample is vaporized, separated by GC based on volatility, then ionized in the MS and...