Encyclopedia
General Pharmacopoeial Article
General pharmacopoeial article - a document approved by the authorized federal executive authority and containing a list of quality parameters and (or) methods of quality control for a specific dosage form, medicinal plant material, descriptions of biological, biochemical, microbiological, physico-chemical, physical, chemical and other methods of analysis of a medicinal product for medical use, as well as requirements for reagents, titrated solutions, indicators used for the purpose of carrying out this analysis1.
Federal Law No. 61-FZ of April 12, 2010 "On the Circulation of Medicinal Products", as amended on April 12, 2010, Art. 4 // RSFSR. 2010. No. 16. Art. 1815. ↩