Type of Posting: Notice of Intent to Revise
Posting Date: 30–Nov–2018
Targeted Official Date: 01–Aug–2020, In-Process Revision
Expert Committee: Non-Botanical Dietary Supplements
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 Non-Botanical Dietary Supplements Expert Committee intends to revise the Taurine monograph.
USP has received comments to the revisions published in the First Supplement to USP 41–NF 36 with supporting data that indicated some of the System Suitability requirements were difficult to meet. The Expert Committee proposes to revise the Assay procedures as follows:
- The System suitability requirements in the Assay procedure for Column efficiency and Relative standard deviation will be changed from NLT 10,000 to NLT 6,000, and from NMT 2.0% to NMT 3%, respectively.
- The requirement for the correlation coefficient for the linear regression line in the Assay procedure is changed from NLT 0.995 to NLT 0.99.
It is anticipated that the proposed revision will be published in Pharmacopeial Forum 45(2) [Mar–May 2019] pursuant to section 7.02 of the Rules and Procedures. The comment period for this revision ends on May 31, 2019. In the absence of any adverse comments the proposed revision will be submitted to ballot for official adoption in the First Supplement to USP 43-NF 38, which will become official on August 1, 2020.
Should you have any questions, please contact Fatkhulla Tadjimukhamedov, Scientific Liaison to the Non-Botanical Dietary Supplements (301–230–3216 or fkt@usp.org).
CN-19-023-00