January 21, 2025 In 21 CFR 211.94 it's said that “Drug merchandise containers and closures shall not be reactive, additive, or absorptive to change the security, identity, strength, good quality or purity of your drug outside of the official or founded demands.” Though the code will make this statement, and when expanded on inside the linked FDA Steering for Field Container Closure Programs for Packaging Human Prescription drugs and Biologics (May perhaps 1999), there is not any prescription made available in tips on how to execute an extractables and leachables analysis, which happens to be, obviously, an essential element of demonstrating suitability of container closure systems. Browse A lot more
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