21/22 October 2020
As reported before the United States Pharmacopeia, USP, published on December 29, 2017, its revised chapter <381> Elastomeric Closures for Injections which became official on January 1, 2018.
The USP General Chapters—Packaging and Distribution Expert Committee has revised General Chapter <381> due to the reference <231> Heavy Metals in USP 41–NF 36. With the impending omission of <231> on January 1, 2018, <381> was revised to include the necessary information to allow execution of the outlined test.
The requirement of not more than 2 ppm of heavy metals as lead (Solution S) remains. The prescribed method and preparation of Standard and Test Preparation corresponds to Method I previously prescribed and included in chapter <231>. However, the use and comparison with the Monitor Preparation has been deleted.
The <381> Elastomeric Closure for Injections Revision Bulletin will supersede the currently official General Chapter. According to USP, the Revision Bulletin will be incorporated in the Second Supplement to USP 41-NF 36 (expected to be released in June, 2018).
For more information please read the Revision Bulletin for chapter <381> on USP´s Revision Bulletins website.