General pharmacopoeia monograph
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Главная Documents Vocabulary General pharmacopoeia monograph
General pharmacopoeia monograph

General pharmacopoeia monograph is a document approved by the authorized federal executive body, containing a list of quality characteristics and (or) quality control methods for a particular dosage form or herbal medicinal raw material, description of biological, biochemical, microbiological, physicochemical, physical, chemical and other methods of analysis of a medicine for medical use, as well as requirements for the reagents, titrated solutions and indicators used for the purpose of such analysis

Source: Russian Federation Law №61-FZ March 24, 2010 "On Circulation of Medicines"

 
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