by Dr. Yashashwini Reddy | May 19, 2025
A Systematic Investigation of Out-of-Specification (OOS) Results in Analytical Testing is a structured approach to identify, evaluate, and resolve instances where test results fall outside predefined specifications. This process is vital in pharmaceutical quality...
by Dr. Yashashwini Reddy | Apr 28, 2025
Investigation of OOS (Out of Specification) Results in Analytical Testing In the context of pharmaceutical and biotechnology industries, Out of Specification (OOS) results refer to test results that fall outside the predefined acceptance criteria for a given product...
by Dr. Yashashwini Reddy | Apr 16, 2025
1. What are the different types of HPLC columns? Reversed-phase columns: These are the most commonly used, where the stationary phase is nonpolar (e.g., C18). Polar compounds are retained longer. Normal-phase columns: The stationary phase is polar, while the mobile...
by Dr. Yashashwini Reddy | Sep 6, 2024
Aim: To lay down the standard operating procedure for operating a moisture analyzer Objective: To establish the standard operating procedure for operating a moisture analyzer at the facility Responsibility: The user department is responsible for implementing the SOP...
