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Experimental validation of methods and procedures featured in draft general pharmacopoeial and pharmacopoeial monographs is an important task for Russian compendial science and practice. These studies provide a basis for adopting state compendial drug quality standards. They enable both manufacturers and quality-control organizations to perform independent quality control of drug substances and medicinal preparations that helps to protect public health.

The current classification of impurities in chemical and mineral drug substances is presented. General approaches to standardization of chemical and mineral drug substances according to the Purity section are given depending on their origin and production technology and considering requirements of international and domestic pharmacopoeial practice

Issues related to regulation of the quality of compounded medicinal preparations by the State Pharmacopoeia of the Russian Federation are considered. Topical questions of the development and implementation of both general clauses and particular monographs related to compounded pharmaceuticals in national pharmacopoeial science and practice are discussed.

Scientific research enabled the formulation of methodological approaches to the standardization of biological, herbal, and homeopathic drugs and their analytical methods included in the Russian Federation State Pharmacopoeia XIIIth Ed. The developed General Pharmacopoeial Articles and Pharmacopoeial Articles are fundamental elements of the standardization of medicines circulated on the Russian Federation pharmaceutical market.

The elixir dosage form according to Russian and foreign pharmacopoeias was analyzed. A list of currently registered Russian and foreign drugs in this dosage form was given. The quality parameters by which drugs in the elixir dosage form must be standardized were listed based on an analysis and generalization of information provided in regulatory documentation of Russian and foreign drug manufacturers.

Standard samples constitute one of the key elements in the medicines standardization system. In pharmacopeia analysis in the Russian Federation and many foreign countries, the use of standard samples is regulated by the corresponding normative documents and pharmacopeia monographs. There are different classifications for standard samples and, depending on purpose, certification programs. Standard samples used in compliance with the requirements of pharmacopeia articles or monographs in international, regional and national pharmacopeias are generally termed pharmacopeia standard samples.

Solutions containing pharmaceuticals of various origins are one of the most popular dosage forms. Pharmaceuticals for parenteral, ophthalmic, internal, and external use, among others, are prepared as solutions. However, a general monograph for the Solutions dosage form has not yet appeared in the Russian State Pharmacopoeia. The principal regulations, including relevant monographs of leading global pharmacopoeias, for the quality requirements of the Solutions dosage form were analyzed and enabled a list of the principal quality parameters of solutions, the techniques and methods for their determination, and the normalized ranges that would be used subsequently to compose a general pharmacopoeial monograph Solutions to be compiled.

Reference standards, including pharmacopoeial reference standards, are widely used for quality assessment of drug substances. Leading global pharmacopoeias contain monographs regulating the requirements for the classification, attestation, and use of reference standards. The drug standardization system in the Russian Federation, which includes drug substances, requires revision for the creation and attestation of national reference standards, including pharmacopoeial ones.