U.S. Food and Drug Administration (2024) Code of Federal Regulations Title 21, Part 211, Subpart E, §211.94—Drug Product Containers and Closures.
https://www.ecfr.gov

has been cited by the following article:

• 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.