Analysis of the Framework and Core Content of the Chinese Pharmacopoeia 2025 Edition “Guidelines for Plastic Materials and Containers Used in Pharmaceutical Packaging”
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Graphical Abstract
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Abstract
Parmaceutical packaging serves as a critical barrier to ensure drug quality and safety, with its standardization and regulatory compliance directly impacting drug efficacy and patient safety. The Chinese Pharmacopoeia 2025 Edition has comprehensively upgraded the quality standards for pharmaceutical packaging materials and containers. Among these, General Chapter 9624 “Guidelines for Plastic Materials and Containers Used in Pharmaceutical Packaging”, stands as the core technical regulation for plastic-based pharmaceutical packaging materials, providing the pharmaceutical industry and packaging manufacturers with scientific and systematic quality control standards. This article systematically analyzed the framework and core content of these guidelines, offering a reference for the production, application, and quality control of pharmaceutical packaging materials.
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