Spring Intro 2023

28/03/2023

3.2.S.6 Container closure system

• Description of container closure system

• Identity of construction materials

• Specifications of materials and final container

• If non-compendial methods have been used, these must be included

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3.2.S.7 Stability

S.7.1 Summary and conclusions ● Types of studies, outline of protocol and summary of results ● Results from forced degradation studies ● Conclusions (shelf life/re-test date, storage conditions).

S.7.2 Post approval stability commitment

S.7.3 Tabulated stability data

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