September 29, 2023

What types of containers are classified as semipermeable containers?

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Examples of semi permeable containers are provided in the ICH Q1A(R2) glossary. The recommendations for stability expectations for semipermeable containers are detailed in ICH Q1A(R2) section II, B, 7, c. Drug products packaged in semi permeable containers (2.2.7.3).

Various cold prescription bottles and a syringe isolated on a white background.

What types of containers are classified as semipermeable containers, and can the Agency clarify the stability expectations for the drug products in semipermeable containers?

Examples of semi permeable containers are provided in the ICH Q1A(R2) glossary. The recommendations for stability expectations for semipermeable containers are detailed in ICH Q1A(R2) section II, B, 7, c. Drug products packaged in semi permeable containers (2.2.7.3).

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What types of containers are classified as semipermeable containers?
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What types of containers are classified as semipermeable containers?
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Examples of semi permeable containers are provided in the ICH Q1A(R2) glossary. The recommendations for stability expectations for semipermeable containers are detailed in ICH Q1A(R2) section II, B, 7, c. Drug products packaged in semi permeable containers (2.2.7.3).
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