Pharmaceutical Analysis: Analytical Techniques, Quality Systems, and Regulatory Perspectives for Ensuring Drug Quality and Safety
Abstract
Throughout the medication research and manufacturing process, pharmaceutical analysis is essential to guaranteeing the efficacy, safety, and quality of pharmaceutical goods. The principles of drug development and the significance of analytical methods in locating, describing, and measuring active pharmaceutical ingredients (APIs) and excipients are the first topics covered in this thorough review of pharmaceutical analysis. It emphasizes the functions of Quality Control (QC) and Quality Assurance (QA) in preserving product uniformity and adherence to Good Manufacturing Practices (GMP). Major regulatory guidelines published by organizations like the Indian Pharmacopoeia, ICH, WHO, and USFDA are also covered in the research, with a focus on how they help standardize pharmaceutical quality globally. Additionally included are fundamental laboratory procedures, Good Laboratory Practices (GLP), reagent preparation, glassware and analytical instrument calibration, and important instrumental methods including potentiometry, pH determination, and UV-visible spectrophotometry. All things considered, this investigation emphasizes how important analytical techniques and regulatory compliance are to obtaining dependable pharmaceutical quality and patient safety.
Fields of Study & Subjects
Pharmaceutical Quality and Counterfeiting
Analytical Methods in Pharmaceuticals
Fisheries and Aquaculture Studies
Publication details
- Journal / source
- International Journal of Medical & Pharmaceutical Sciences
- Publication date
- 2 January 2026