TITLE:
Strengthening Extractable & Leachable Study Submissions: Best Practices to Avoid Regulatory Deficiencies
AUTHORS:
Subathra Ramamoorthy, Ngee Sing Chong, Kishore Kumar Hotha
KEYWORDS:
Extractables and Leachables, Pharmaceutical Container Closure Systems, Manufacturing Equipment, Guidance, Regulatory Standards, Prototype Procedures
JOURNAL NAME:
American Journal of Analytical Chemistry,
Vol.15 No.12,
December
26,
2024
ABSTRACT: 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.