Influence Of Some Parameters On The Approximation Of Eu Pharmacopoeia And Iso Standard 4802: Reasons For Harmonisation

The most widely used Standards to test the inner surface of glass containers for pharmaceutical use, EU Pharmacopoeia and ISO 4802, may differ significantly in the results because of relevant differences in the procedures. In this study the rinsing procedures, effect of prolonging the cooling time to 95 deg C, as prescribed by EN norms on safe operation practice, and the combination of the two factors were investigated. Nine labs participated in the collaborative study, the resulting extract solutions were analysed both by titration and flame photometry. Results were evaluated by two way ANOVA with the aim of estimating three sources of variation: between procedures, between laboratories and random variation due to experimental error.