Influence of some parameters on the approximation of European Pharmacopoeia and ISO Standard 4802 : Reasons for harmonization - a collaborative study of ICG/TC2, `Chemical Durability and Analysis'

• The most widely used Standards to test the inner surface of glass containers for pharmaceutical use, European 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 °C, as prescribed by EN norms on safe operation practice, and the combination of the two factors were investigated. Nine laboratories participated in the collaborative study, the resulting extract solutions were analyzed 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. For soda-lime-silica glass there is evidence that the different procedures influence the hydrolytic resistance of the inner surface of glass containers whichever method is used. Differences between laboratories were, however, much greater and results vary more due to which laboratory conducted the measurement rather than which procedure is employed. For borosilicate glass variations between procedures were found not to be significant. It is strongly recommended that ISO and EP shall adopt measures to minimize those factors that proved to exert great influence on reproducibility of results.

Ämnesord

TEKNIK OCH TEKNOLOGIER  -- Kemiteknik (hsv//swe)

ENGINEERING AND TECHNOLOGY  -- Chemical Engineering (hsv//eng)

Nyckelord

Chemical engineering

Kemiteknik

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