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Sodium Bromide Monograph Revision: Volumetric Solution References

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Summary

USP's Small Molecules Therapeutic Areas 6 Expert Committee has issued a Notice of Intent to Revise the Sodium Bromide monograph. The proposed changes update volumetric solution references used in the Limit of chlorine and Assay tests to match current reagent entries and include missing normality specifications. Specifically, the notice proposes replacing 'ammonium thiocyanate VS' with '0.1N ammonium thiocyanate VS' and 'silver nitrate VS' with '0.1N silver nitrate VS'. The implementation vehicle and official date remain to be determined.

“Replace "ammonium thiocyanate VS" with "0.1N ammonium thiocyanate VS"”

USP , verbatim from source
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What changed

The Notice of Intent to Revise proposes amendments to the Sodium Bromide monograph to update references to volumetric solutions. The specific changes are: replacing 'ammonium thiocyanate VS' with '0.1N ammonium thiocyanate VS' and replacing 'silver nitrate VS' with '0.1N silver nitrate VS'. These changes address customer queries and ensure consistency with reagent entries in the compendium.

Pharmaceutical manufacturers and drug substance producers using the Sodium Bromide monograph should monitor for the final revision notice and implementation date. Since the official date and implementation vehicle are to be determined, affected parties should watch for follow-up communications from USP specifying when the updated monograph will take effect.

Archived snapshot

Apr 28, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Notice of Intent to Revise: Sodium 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 Sodium 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)

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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
Drug manufacturers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Monograph revision Quality standards Reagent specifications
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Regulatory Affairs
Topics
Healthcare Chemical Manufacturing

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