Comparison of Soxhlet and Accelerated Solvent Extraction for Leachable and Extractable Analysis of Packing Material
نویسندگان
چکیده
Introduction According to the regulations and guidelines set by regulatory agencies, including the U.S. Food and Drug Administration (US FDA),1 the European Medicines Agency (EMA),2 extractable and leachable information must be included in applications for medical devices and container closure systems packaging for human drugs and biologics. The specific applications include the New Drug Application (NDA), Abbreviated New Drug Application (ANDA) and Biologics License Application (BLA).
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