January 21, 2025 In 21 CFR 211.94 it's stated that “Drug solution containers and closures shall not be reactive, additive, or absorptive to alter the protection, id, strength, top quality or purity in the drug further than the official or recognized requirements.” Though the code helps make this statement, and if expanded on from the linked FDA Direction for Field Container Closure Units for Packaging Human Medication and Biologics (Might 1999), there isn't a prescription presented in the way to execute an extractables and leachables analysis, which happens to be, naturally, An important facet of demonstrating suitability of container closure units. Read Additional
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