Chapter 1. Introduction to Pharmaceutical Analysis
Synopsis
Author
Mr. Gourab Saha
Assistant Professor, Department of Pharmaceutics, College of Pharmaceutical Sciences, Berhampur, Mohada, Odisha, India
Abstract
Pharmaceutical analysis serves as the cornerstone of drug development, providing critical tools for quality assessment throughout product lifecycles. Analytical chemistry principles establish the scientific foundation for identifying, quantifying, and characterizing drug substances and products. These methods fulfill essential functions from early discovery through commercialization, including impurity profiling, stability determination, and quality control. Current FDA, EMA, and ICH guidelines create a regulatory framework that governs analytical procedures globally. The pharmaceutical industry faces evolving analytical challenges with trends toward continuous manufacturing, real-time release testing, and miniaturization driving innovation. Analytical chemistry functions as both scientific discipline and practical toolset, ensuring drug safety, efficacy, and quality. Method selection decisions rely on specific analytical questions, available resources, and regulatory requirements.
Keywords: Pharmaceutical analysis, Drug quality assessment, Analytical method selection, Regulatory bodies, Analytical technology
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