Approach formation for the development of compounding preparation monographs
Questions of standardization of compounding preparations are quite relevant both in Ukraine and abroad. Today the general monograph «5.N.1. Extemporaneous preparations» of the State Pharmacopoeia of Ukraine is revised by the staff of the Ukrainian scientific pharmacopoeial center for quality of medicines and the National University of Pharmacy, also the additional articles for compounding preparations are developed.
The aim of this work is substantiation of the structure and format of the compounding preparation monographs for introduction to the national part of the State Pharmacopoeia of Ukraine.
The researches were performed using data of the world pharmacopoeias and national formularies, as well as the experience of standardization of compounding preparations in Ukraine and the USSR.
In the study, general statements for the development of compounding preparations monographs were formed and its structure was discussed. The requirements and examples are described for each item of the monograph. For monographs of the State Pharmacopoeia of Ukraine such structure were offered: name, composition, lists the acceptable range of labeled amount of main ingredient, technology of preparation, reference for the general monographs, properties, identification, tests, assay, expiration date, labeling, storage, references to the regulatory documents, and indications. For systematization of the monographs’ development procedure the work order was composed. The procedure of monographs development includes selection of the object, study of literature data, and study of the basic stages of the compounding process, evaluation of quality control methods, experimental researches, and conclusion about conformity with the requirements, quality control method validation protocols, stability studies, and development of the monograph’s draft.
As the result of research the structure, format, stages and order of the development of compounding preparations’ monographs for introduction to the State Pharmacopoeia of Ukraine were proposed.
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