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Loperamide Hydrochloride

Type of Posting: Notice of Intent to Revise
Posting Date: 27–Mar–2020
Targeted Official Date: 01–Jun–2020, Revision Bulletin
Expert Committee: Chemical Medicines Monographs 3 Expert Committee

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 Loperamide Hydrochloride monograph to address the inadvertent omission of text that was published in Pharmacopeial Forum (PF) and approved by the Expert Committee.  

Specifically, a revision for IMPURITIES, Organic Impurities was proposed in PF 43(4), and ultimately was approved by the Expert Committee. However, Total Impurities was inadvertently omitted from IMPURITIES, Organic Impurities Table 2 when the monograph was published as final approved text in the USP-NF

The Chemical Medicines Monographs 3 Expert Committee proposes to address this issue by publishing a Revision Bulletin to include Total Impurities in IMPURITIES, Organic Impurities Table 2. The Revision Bulletin is expected to become official June 1, 2020. All other changes proposed in PF 43(4) for the Loperamide Hydrochloride monograph are scheduled to become official May 1, 2020.     

Should you have any questions, please contact Andrea F Carney, Scientific Liaison to the Chemical Medicines Monographs 3 Expert Committee (301–816–8155 or afc@usp.org).


CN-20-042-00