Standard [WITHDRAWN] 2012-12
Due to its properties glass is traditionally used as primary packaging material both for pharmaceutical preparations and medical devices. Hydrolytic properties of glass, that is the property to release alkaline compounds at high temperatures in the presence of water, play an important role in this context. Compounds released into the pharmaceutical preparation may effect changes of the pH value and consequently influence stability or other properties of the pharmaceutical preparation. The DIN ISO 4802 series specifies two test methods in Part 1 and Part 2 which determine hydrolytic resistance of the interior surfaces of glass when exposed to water with a temperature of 121 °C: - titration method (Part 1) - flame spectrometry method (Part 2). The titration method is based on the method described in the European Pharmacopoeia, although this standard describes the test conditions, in particular the autoclaving cycle, in more detail in order to increase the reproducibility of the test results. In the procedures, distinction according to different containers is made. The description of the methods is also supplemented by a corresponding classification of the containers. The DIN ISO 4802 standard series supersedes the DIN 52339 standard series. With respect to DIN 52339 in particular the sample preparation, determination of the filling volume and the information in the test report have been revised. Furthermore, information in Table 2 concerning the maximum values regarding water resistance have been partly supplemented or revised. The standards are based on the ISO 4802 standard series which has been prepared by ISO/TC 76 and adopted without any modifications into the German body of standards. The responsible Working Committee at the Medicine Standards Committee (NAMed) is NA 063-02-03 AA "Primärpackmittel-Behältnisse" ("Primary packaging material containers").