Solutions: Characteristics, Classification, and Basic Quality Requirements


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Abstract

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.

About the authors

O. A. Mochikina

Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
Russian Federation, Moscow, 125051

E. I. Sakanyan

Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
Russian Federation, Moscow, 125051

T. B. Shemeryankina

Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
Russian Federation, Moscow, 125051

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