pH adjustment and monitoring of hydrogen carbonate buffers Physiolution GmbH Walther-Rathenau-Strasse 49a 17489 Greifswald, Germany www.physio-stat.com electrode potential CO2 electrode CO2 CO2 diffusor The pHysio-stat® enables pH adjustment and monitoring of hydrogen carbonate buffers during dissolution testing. The pHysio-stat® is an automated microprocessor-driven system which enables the adjustment of the media pH in a dissolution vessel. The pHysio-stat® is composed of a pH electrode, a gas diffusor, a digital microcontroller and a proportional valve. The device is driven by custom-made software which controls the pH adjustment in the range of pH 5.5 to 9.0 and enables the setting of trigger values as well as a regulation hysteresis within the pharmacopoeial tolerance range of ± 0.05 pH. The pH electrode and the gas diffusor remain immersed in the dissolution medium. This allows that the pH is measured over the entire dissolution experiment and is instantly applicable for the regulation of the proportional valve that adjusts the amount of CO2 introduced into the dissolution medium via the diffusor. The pHysio-stat® device: • can precisely monitor and adjust the pH value of commonly used hydrogen carbonate buffers such as Hanks and Krebs buffer solutions and modifications of biorelevant media • enables a precise pH adjustment in the range of pH 5.5 to 9.0 with a maximum deviation of ± 0.05 pH units • utilizes pure CO2 as well as mixtures of CO2 with other gases as a titer • is characterized by high robustness, excellent performance stability as well as extre mely high dynamics of the pH adjustment processes • can be used in various pharmacopoeial and non-compendial dissolution test devices. These unique features make the pHysio-stat® not only very useful for applications in research and development but also very efficient for routine applications in dissolution tests in which hydrogen carbonate based buffers are utilized. Physiolution GmbH Walther-Rathenau-Strasse 49a 17489 Greifswald, Germany www.physio-stat.com Grzegorz Garbacz, Ph.D. [email protected]
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