United States Pharmacopeia (USP) is continuously expanding the USP <1664> series—guidelines for leachables evaluation in pharmaceutical products—through dosage form–specific chapters to better reflect patient exposure risks based on formulation characteristics and routes of administration.

 

As part of this expansion, a new draft chapter, USP <1664.3>, focused on topical ophthalmic drug products, was released in November 2025. This chapter introduces dosage form–specific, risk-based evaluation approaches that complement conventional leachables assessment strategies by considering the unique characteristics and usage environments of ophthalmic formulations, including solutions, suspensions, emulsions, and ointments.

 

USP <1664.3> addresses how interactions among ophthalmic drug products, manufacturing equipment, and packaging and container-closure systems should be evaluated throughout the product lifecycle. It is expected to serve as an important reference for future ophthalmic product development and regulatory submission strategies.

 

Through this webinar, Eurofins will present key highlights of USP <1664.3>, along with practical leachables evaluation strategies applicable to ophthalmic products, analytical approaches, and insights into relevant regulatory trends.

 

 

  ■ Title

      USP 1664.3: Understanding the New Chapter on Leachables Assessment for Topical Ophthalmic Drug Products

  ■ Date&Time

      March 5, 2026 (Thu), 6:30 PM – 7:30 PM (KST)

  ■ Topics

      • Regulatory Landscape and Overview of USP <1664.3>
      • Analytical Testing Implications for Leachables Assessment for Ophthalmic Drug Products
      • Regulatory and Compliance Impact of USP’s Dosage‑Form–Specific Chapters
      • Q&A session

 

For more details, please visit the webinar registration page via the “Register Now” button below.
We look forward to your interest and participation.

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