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Content archived on 2024-04-16

ALKALI LEACHING FROM PHARMACEUTICAL GLASS CONTAINERS

Objective



Glass containers for injectable solutions must comply with specifications of the European Pharmacopoeia (also ISO 4802) which limit the release of alkaline constituents into pure water when applying a specific test. The test method consists of:
- applying a specified temperature cycle to containers, partially filled with pure water(in equilibrium with the atmosphere), in an autoclave
- subsequent determination of total alkalinity (titration) of the water or of specified elements (Na and possibly others).
The test method imposed by the European Pharmacopoeia is not ideal. The test is very sensitive to minor differences in the temperature cycle applied. It appears in fact that most cases of observed high leaching are caused by measurement errors and not by poor quality of the glass. Potential sources of error have been identified and largely eliminated in preliminary intercomparisons. A reference material will be certified to enable laboratories to check if the method is applied correctly.

Topic(s)

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Call for proposal

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Coordinator

Institut National du Verre
EU contribution
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Address

Charleroi
Belgium

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Participants (12)