USP 166 4 Leachable 包材析出物研究方法（英文版）.pdfVIP

BRIEFING 〈1664〉Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging Delivery Systems. In the 2010–2015 cycle, the Packaging, Storage, and Distribution Expert Committee determined the need to update general chapters that speak to the quality of the packaging systems used to store drug products. The Expert Committees initial focus was on the final packaging systems; however, it had been extended to include packaging systems components and their materials of construction. The suitability of a pharmaceutical packagi