January 21, 2025 In 21 CFR 211.94 it can be said that “Drug item containers and closures shall not be reactive, additive, or absorptive to alter the safety, id, power, excellent or purity from the drug over and above the Formal or founded specifications.” When the code makes this assertion, and if expanded on inside the related FDA Guidance for Industry Container Closure Systems for Packaging Human Medications and Biologics (May well 1999), there's no prescription presented in how to execute an extractables and leachables analysis, which can be, not surprisingly, an essential aspect of demonstrating suitability of container closure systems. Read More
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