Strengthening Extractable & Leachable Study Submissions: Best Practices to Avoid Regulatory Deficiencies  

作　　者：Subathra Ramamoorthy Ngee Sing Chong Kishore Kumar Hotha Subathra Ramamoorthy;Ngee Sing Chong;Kishore Kumar Hotha(Department of Chemistry, Middle Tennessee State University, Murfreesboro, TN, USA;Dr. Hothas Life Sciences LLC, Ayer, MA, USA)

机构地区：[1]Department of Chemistry, Middle Tennessee State University, Murfreesboro, TN, USA [2]Dr. Hothas Life Sciences LLC, Ayer, MA, USA

出　　处：《American Journal of Analytical Chemistry》2024年第12期368-394,共27页美国分析化学(英文)

摘　　要：The assessment of extractable and leachables (E&L) has become a cornerstone of pharmaceutical product safety, yet no unified global standards currently exist to quantify or report E&L from container closure systems. While initially limited to primary packaging, E&L evaluations now encompass secondary packaging, manufacturing equipment, and medical devices. Key milestones include the FDA’s 1999 guidance on container closure systems and more recent frameworks from USP chapters , , and , as well as PQRI recommendations. These guidelines have set the foundation for conducting E&L studies, especially for high-risk dosage forms, and are complemented by the forthcoming ICH Q3E, which aims to standardize E&L considerations across dosage forms. This article outlines a structured procedure for E&L assessments, integrating regulatory expectations with practical insights.The assessment of extractable and leachables (E&L) has become a cornerstone of pharmaceutical product safety, yet no unified global standards currently exist to quantify or report E&L from container closure systems. While initially limited to primary packaging, E&L evaluations now encompass secondary packaging, manufacturing equipment, and medical devices. Key milestones include the FDA’s 1999 guidance on container closure systems and more recent frameworks from USP chapters , , and , as well as PQRI recommendations. These guidelines have set the foundation for conducting E&L studies, especially for high-risk dosage forms, and are complemented by the forthcoming ICH Q3E, which aims to standardize E&L considerations across dosage forms. This article outlines a structured procedure for E&L assessments, integrating regulatory expectations with practical insights.

关 键 词：Extractables and Leachables Pharmaceutical Container Closure Systems Manufacturing Equipment GUIDANCE Regulatory Standards Prototype Procedures 

分 类 号：R74[医药卫生—神经病学与精神病学]