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〈383〉 Cured Silicone Elastomers for Pharmaceutical Packaging and Manufacturing Components

BRIEFING

 〈383〉 Cured Silicone Elastomers for Pharmaceutical Packaging and Manufacturing Components. The General Chapters—Packaging and Distribution Expert Committee is proposing the following revisions to address comments received with the publication of this new chapter in March 2024. The following changes are proposed:

  1. Revise the Scope to clarify the applicability of the chapter to cured silicone elastomers used for manufacturing components.

  2. Move the Iodine solution preparation procedure from the Physicochemical Tests, Residual peroxides section to the Physicochemical Tests, Reducing substances section.

  3. Delete Procedure 1 and Acceptance criteria 1 from the Physicochemical Tests, Residual peroxides section.

 (GCPD: D. Hunt)

 Case ID—SUB-1126

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