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Potassium Bromide Monograph Revision: Volumetric Solution Updates

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Summary

USP has issued a Notice of Intent to Revise the Potassium Bromide monograph to update references to volumetric solutions used in the Limit of chlorine and Assay tests. The proposed changes replace 'ammonium thiocyanate VS' with '0.1N ammonium thiocyanate VS' and 'silver nitrate VS' with '0.1N silver nitrate VS' to align with reagent entries and include missing normality information. The Targeted Official Date remains to be determined.

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What changed

USP proposes technical corrections to the Potassium Bromide monograph under the Small Molecules Therapeutic Areas 6 Expert Committee. The revision updates two volumetric solution references to include specific normality values (0.1N) for consistency with USP reagent entries and to address customer queries about missing normality information. The first change updates 'ammonium thiocyanate VS' to '0.1N ammonium thiocyanate VS' and the second updates 'silver nitrate VS' to '0.1N silver nitrate VS' in the Limit of chlorine and Assay test sections. Pharmaceutical manufacturers and testing laboratories using this monograph should monitor for the final implementation date and update their Standard Operating Procedures accordingly when the revision is officially adopted.

Archived snapshot

Apr 28, 2026

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Notice of Intent to Revise: Potassium Bromide

Type of Posting: Notice of Intent to Revise
Posting Date: 24-Apr-2026
Targeted Official Date: TBD
Expert Committee: Small Molecules Therapeutic Areas 6

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that USP intends to revise the Potassium Bromide monograph.

To address the customer queries received, it is proposed to update the references to the volumetric solutions used under the tests for Limit of chlorine and the Assay, to make them consistent with the reagent entries. It is also proposed to include the missing information for normality of these solutions, based on the supporting information from the original submission

  • Replace “ammonium thiocyanate VS” with “0.1N ammonium thiocyanate VS”
  • Replace “silver nitrate VS” with “0.1N silver nitrate VS”. It is anticipated that this revision will be implemented using a suitable revision vehicle, with the official date to be determined.

Should you have any questions, please contact Hillary Cai, Senior Manager (hzc@usp.org)

Named provisions

Limit of chlorine Assay

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Last updated

Classification

Agency
USP
Published
April 24th, 2026
Instrument
Notice
Branch
Independent
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Pharmaceutical companies Drug manufacturers Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Pharmaceutical testing Quality control
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Quality Assurance
Compliance frameworks
GxP
Topics
Quality Assurance Healthcare

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