New USP General Chapters on Extractables and Leachables: <1663>, <1664>

Two new USP General Chapters on extractables and leachables which had been proposed in Pharmacopeial Form 39 (5) have become official on August 1, 2015 (USP 38-NF33, first supplement):

  • <1663>  Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems and
  • <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery systems.

These chapters are intended to be informational. They provide a framework for the design, justification, and execution of extractables/leachables assessments for pharmaceutical packaging systems. They do not present specific experimental conditions, specific tests, analytical procedures or acceptance limits for packaging systems or products.

Additionally, the PSD Expert Committee plans a general chapter <1665> on the Toxicological Safety Assessment of Extractables and Leachables (announced in PF and 39(6)). The chapter is expected to provide a framework for performing a toxicological safety assessment. It is not expected to provide specific protocols or specifications.

However, the above mentioned General Chapters might get a more official character when implemented in USP Monographs or General Chapters on dosage forms products-quality tests. In the recent issue of PF 41(5) reference to the two new Chapters <1663>  and <1664> has been integrated in the Drafts of General Chapters on Ophthalmic Products <771> and Injections <1>. Therefore, in future, it might be necessary to discuss the scientific principles and best demonstrated practices for extractables/leachables studies. In addition, the assessment of possible leachables/extractables and the establishment of acceptance criteria for these substances might be based on risk assessments for a specific combination of product, indication, route of administration, and packaging system. The comment deadline for the in PF 41(5) proposed chapters is November 30, 2015. 

Following your registration on the USP Pharmacopeial Forum  website you can get to the complete drafts of the USP General Chapters.

Looking for more Information? Be part of next year's course on Leachables & Extractables - Testing & Assessment - from 26-27 April 2016 in Copenhagen!

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