Illustration of pharmaceutical water system testing with TOC and conductivity meters, referencing USP Chapter draft revision for public comment.

USP Revises Chapter <1231> on Pharmaceutical Water — Draft Open for Comment

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USP has published a revised draft of Chapter <1231> “Water for Pharmaceutical Purposes” in PF 51(4). Updates clarify ozone limits, online TOC/conductivity testing, additive risk assessments, and new nitrosamine guidance.

USP Revises Chapter <1231> on Pharmaceutical Water — Draft Open for CommentThe draft is open for public comment until 30 September 2025 on the Pharmacopeial Forum website. Free registration is required.

Illustration showing pharmaceutical documentation, data integrity, and USP Chapter draft open for public comment until 30 September 2025

USP Publishes Draft Chapter <1029> on Good Documentation Guidelines and Data Integrity – — Draft Open for Comment

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The United States Pharmacopeia (USP) has released a draft of Chapter <1029> titled “Good Documentation Guidelines and Data Integrity” for public comment in the USP Pharmacopeial Forum as of early July 2025. The draft revises the 2018 version and incorporates expanded guidance on documentation practices and data integrity.

Stakeholders can submit comments until 30 September 2025 after registering on the Pharmacopeial Forum website – link.