January 21, 2025 In 21 CFR 211.94 it is mentioned that “Drug merchandise containers and closures shall not be reactive, additive, or absorptive to alter the security, id, energy, top quality or purity on the drug over and above the Formal or recognized prerequisites.” Though the code will make this assertion, and when expanded on from the relevant FDA Guidance for Market Container Closure Programs for Packaging Human Medicines and Biologics (May 1999), there isn't any prescription provided in how to execute an extractables and leachables analysis, which is, not surprisingly, An important element of demonstrating suitability of container closure systems. Study Far more
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