Tag: Leachables and Extractables

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Featured image for a GMP Insiders article on USP Pharmacopeial Forum 52(5), showing regulatory documents clipped together. The issue includes proposals on oral drug product leachables, glycol impurity testing, and revisions to compendial Identification requirements.

USP PF 52(5): New General Chapter ⟨1664.5⟩ on Oral Drug Product Leachables, Revised ⟨469⟩ Glycol Test, and General Notices Revisions

USP Pharmacopeial Forum 52(5) introduces proposals covering oral drug product leachables, glycol impurity testing in ethoxylated substances, and revisions to...
USP–NF PF 51(6) draft updates announced for November 2025, including revisions to chapters ⟨1225⟩ Analytical Lifecycle, ⟨1771⟩ Ophthalmic Products, ⟨1664.1⟩ and ⟨1664.3⟩ Leachables for OINDP and Eye Drops, and ⟨825⟩ Radiopharmaceutical Standards.

USP–NF PF 51(6) Draft: What is New?

USP–NF PF 51(6) draft updates modernize analytical validation, ophthalmic standards, leachables guidance, and radiopharmaceutical practices....

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