The following publication describes the background, general conditions and guidelines of the finished product monograph for the manufacture and quality of a preserved epinephrine hydrogentartrate/epinephrine hydrogentartrate solution (0.1%) for external use.

Currently, only a basic version exists for magisterial preparation in pharmacies with a manufacturing description for small scale with very limited shelf life as well as no analytics. Currently, there is no current, quality-assured regulatory system, adapted to the market situation/requirements, according to which the production is carried out. Therefore, the inclusion and development of the monograph is so relevant to bring production and consumers up to date.

The production of the monograph was supported by the Federal Ministry of Digitalization and Economic Location.

R. MACAS*, W. DOIBER, T. LANG, A. LEIDWEIN, K. RAINER, R. STARK, J. STEINHÄUSLER, N. WALTER