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 28, 2025
Resolving API Impurity Issues in Drug Development:- In pharmaceutical drug development, Active Pharmaceutical Ingredients (APIs) are the core components responsible for the therapeutic effect of a drug. However, during the manufacturing and synthesis of APIs,...
by Dr. Yashashwini Reddy | Apr 28, 2025
Understanding the Stability of Injectable Products Injectable products — such as vaccines, biologics, and sterile pharmaceuticals — must maintain strict stability to ensure their safety, efficacy, and quality throughout their shelf life. Stability refers to the...
by Dr. Yashashwini Reddy | Apr 27, 2025
Standard Operating Procedure (SOP) 1. Purpose The purpose of this SOP is to outline the proper cleaning procedure for the Melting Point Apparatus to ensure accurate measurements and maintain the equipment’s proper functioning. 2....
by Dr. Yashashwini Reddy | Apr 27, 2025
Standard Operating Procedure (SOP) 1. Purpose This SOP outlines the procedure for cleaning the Box Compression Strength Tester to ensure the accurate measurement of compression strength in boxes or packaging materials. Regular cleaning...
