INTRODUCTION

This course for Drug Analysis and Control is designed for second-year Master's students in Pharmaceutical Chemistry, and is also suitable for those in Pharmaceutical Engineering and Pharmacy programs.

The content integrates fundamental chemical principles with their specialized applications to ensure the safety, efficacy, and quality of medicinal products. The knowledge presented in these chapters forms the essential foundation supporting the pharmaceutical industry's commitment to public health. Drawing on several years of teaching experience in this field, this COURSE aims to provide students with comprehensive support to master the essential concepts of pharmaceutical quality control.

This handout has been developed in accordance with the official program curriculum. It guides students from broad regulatory frameworks to the detailed application of analytical techniques for specific drug classes.

The essential context is first established in Chapters I and II, which examine the State System Structure in Quality Control and the rigorous preparation of technical documentation for standards. The core principles of pharmaceutical analysis are systematically presented in Chapter III, detailing specific characteristics, essential criteria, method validation parameters, and the general principles for establishing the authenticity of medicinal substances. Chapter IV discusses the types of technical analysis within a pharmaceutical complex. This theoretical foundation is complemented by the practical aspects covered in Chapter V: Sample Selection, emphasizing that the validity of any sophisticated analysis depends entirely on obtaining representative samples.

A comprehensive examination of modern pharmaceutical quality control methods is provided in Chapters VI through X. Chapter VI discusses sterilization methods for microbiological safety; Chapter VII presents ash analysis for purity assessment; Chapter VIII details physical characterization methods, including melting point and optical rotation determination; Chapter IX covers chemical analysis techniques through titrimetric methods and functional group identification; and Chapter X explores advanced physicochemical instrumentation, including spectral, chromatographic, and electrochemical techniques that form the core of modern quality control laboratories. Subsequent chapters (XI-XIV) apply these methods to specific drug classes, including aliphatic, aromatic, heterocyclic, and alkaloid compounds.

Upon completion of this course, students will be equipped not only to perform these analyses but also to critically evaluate analytical data, develop robust quality control protocols, and contribute to advancements in pharmaceutical sciences.