Pharmaceutical chemistry studies a wide range of issues related to medicinal substances including the production process, the structure of a drug substance and the composition of a drug, the relationship between the structure of a substance and its biological activity, physicochemical and chemical properties of drugs and quality control methods. Pharmaceutical chemistry also determines the storage conditions of medicinal substances. Medicinal chemistry studies a similar range of issues and mainly considers medicinal substances within biochemical processes, metabolism, molecular and cellular biology. Medicinal chemistry also studies the relationship between the structure and properties of medicinal substances using computer simulation methods. At the same time, pharmaceutical chemistry focuses on the quality control of drugs.
Quality control of drugs (active pharmaceutical ingredients also called pharmaceutical substances and finished pharmaceutical products) includes identification tests, impurity tests and assay methods. These three main aspects of pharmaceutical analysis are studied during the pharmaceutical chemistry course.
Drug quality means compliance of the drug with the requirements of the pharmacopoeial monograph.
A general pharmacopoeial monograph is a document containing a list of quality indicators and (or) methods for quality control of a particular dosage form, medicinal plant raw materials, descriptions of biological, biochemical, microbiological, physical, chemical and other methods of analysis of medicinal products, as well as requirements for reagents, titrated solutions, indicators used for the purpose of this analysis.
The Pharmacopoeia is the set of general pharmacopoeial monographs and pharmacopoeial monographs. There are national Pharmacopoeias (for example, the United States Pharmacopoeia - USP, the State Pharmacopoeia of the Russian Federation - SPhRF, the Japanese Pharmacopoeia, etc.), supranational Pharmacopoeias (the European Pharmacopoeia, Pharmacopoeia of the Eurasian Economic Union - Ph. EAEU) and the International Pharmacopoeia (Ph. Int.) published by the World Health Organization. Supranational pharmacopoeias (for example, the European Pharmacopoeia) are recognized in the member states of supranational associations (European Union) and do not replace national Pharmacopoeias but contribute to the harmonization of requirements. Nowadays, there is universal tendency towards harmonization of the pharmacopoeial requirements in order to ensure high quality of medicines around the world.