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Aspirin Boluses

Type of Posting: Notice of Intent to Revise

Posting Date: 29–Apr–2016

Targeted Official Date: 25–Nov–2016, Interim Revision Announcement

Official Date: 01–Jan–2017

Archive Date: 24–Jun–2016

Expert Committee: Chemical Medicines Monographs 3

In accordance with section 7.04 (c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that the Chemical Medicines Monographs 3 Expert Committee intends to revise the Aspirin Boluses monograph.

The current procedure for Limit of Salicylic Acid in the Aspirin Boluses monograph utilizes a Standard solution consisting of both USP Salicylic Acid RS and USP Aspirin RS to determine the suitability of the system as well as calculate the percentage of salicylic acid in the Aspirin Boluses. Comments were received that indicate that a small amount of salicylic acid in USP Aspirin RS may lead to erroneous results when performing the procedure for Limit of Salicylic Acid. The Expert Committee proposes the following revisions to the Aspirin Boluses monograph:

  • The test for Limit of Salicylic Acid is revised to add a separate Salicylic acid standard solution to avoid errors due to salicylic acid that may be present in USP Aspirin RS.
  • The Assay is revised to add a dilution step to the Sample solution preparation to be consistent with Standard solution and the availible data. In addition, the calculation formula is updated.
  • A resolution requirement is added to the System Suitability evaluation for both the Assay and Limit of Salicylic Acid based on available data.
  • The test for Dissolution is revised to clarify the preparation of the Standard solution and to add the appropriate calculation.

It is anticipated that the proposed revision will be published as an Interim Revision Announcement (IRA) in Pharmacopeial Forum 42(4) [Jul.–Aug. 2016] pursuant to section 7.02 of the Rules and Procedures. The comment period for this revision ends on September 30, 2016. In the absence of any adverse comments the proposed IRA will become official on January 1, 2017.

Should you have any questions, please contact Morgan Puderbaugh, Scientific Liaison to the Chemical Medicines Monographs 3 Expert Committee (301–816–8373 or