Type of Posting: Notice of Intent to Revise
Posting Date: 03-Jan-2022
Targeted Official Date: 01-Jan-2022
Expert Committee: Small Molecules 2
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 2 Expert Committee has revised the Prazosin Hydrochloride monograph to correct the concentration of the Sensitivity solution in the Organic impurities section.
Comments were received that indicate the concentration of the Sensitivity solution in the Organic impurities section was inconsistent with the value of the reporting threshold listed in the monograph. Based on the review of supporting data, it was found that the incorrect concentration was inadvertently introduced during the publication in Pharmacopeial Forum PF 45(4) [July-Aug 2019]. An Erratum was published on December 31, 2021 to correct the concentration of the Sensitivity solution from 0.05 µg/mL to 0.5 µg/mL.
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