Pharma Knowledge

HPLC Chromatographic Spiking: Possible Causes and Troubleshooting Solutions How to Troubleshoot HPLC Spikes In High-Performance Liquid Chromatography (HPLC), chromatographic spiking generally refers to a sudden, narrow upward or downward disturbance in the baseline. It may result from air bubbles, pump instability, detector problems, mobile-phase incompatibility, contamination, or sample-related issues. For pharmaceutical analytical development, the most … Read more

Force Degradation Studies Force degradation, also called stress testing, is performed during pharmaceutical development to understand how an API or drug product behaves under different stress conditions and to demonstrate that the analytical method is stability-indicating. 1. Typical Force Degradation Conditions Stress condition Typical starting condition Purpose Acid hydrolysis 0.1 N HCl, 60°C Evaluate acid-sensitive … Read more

HPLC column leakage-Troubleshooting Learn the common causes of HPLC column leakage, how to identify leakage from column fittings, ferrules, end fittings and connections, and practical ways to troubleshoot and prevent HPLC leaks. HPLC column leakage is a common problem encountered during HPLC method development, method validation, routine analysis, and troubleshooting. A small leak around the … Read more

Assay Method Validation Introduction: Assay method validation is one of the most important activities in pharmaceutical analytical development. Before an analytical method is used routinely for testing a drug substance or drug product, it should be demonstrated that the method is suitable for its intended purpose. In simple words, assay method validation proves that an … Read more

GMP Good Manufacturing Practices: GMP is one of the most important concepts in the pharmaceutical industry. It ensures that medicines are consistently manufactured and controlled according to predefined quality standards. GMP is not limited to testing the finished product; it covers the entire manufacturing process, including raw materials, equipment, personnel, documentation, production, quality control, packaging, … Read more