by Dr. Yashashwini Reddy | Oct 9, 2025
Analytical procedure development is the process of designing and optimizing methods to accurately and precisely measure the active pharmaceutical ingredient (API), excipients, impurities, and degradation products in a drug substance or drug product. The goal is to...
by Dr. Yashashwini Reddy | Aug 8, 2025
Steps for HPLC Method Development 1. Define the Purpose Identify the analyte(s) to be separated and quantified. Define method requirements (accuracy, precision, sensitivity, run time). 2. Gather Information Chemical structure, polarity, pKa, solubility of the analyte....
