Type of Posting: General Announcement
Posting Date: 31-Mar-2023
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that USP Headquarters intends to omit the Solubilities: Approximate Solubilities of USP and NF Articles and the Containers for Dispensing Capsules and Tablets reference tables.
Comments were received from stakeholders alerting USP about discrepancies between the information included in the Solubilities: Approximate Solubilities of USP and NF Articles reference table and the solubility information provided as a part of the FDA-approved labels of the products. The reference table was first included in USP 18 in 1970 to serve as a helpful source of information in the pre-internet era. This table does not include any references to the original sources of the information and is not referenced in any USP-NF standards
USP ceased updating the Containers for Dispensing Capsules and Tables reference table as of May 1, 2021. Because this information is no longer updated, the table is no longer relevant and should not be used. Information on container specifications can be found in individual monographs in the Additional Requirements section, if applicable.
USP intends to mark both tables for omission in USP 2023 Issue 3, available on June 1, 2023. The omissions would become official on December 1, 2023, at which time these tables would be marked as Omitted. The historic versions of these reference tables can always be accessed in the USP-NF Online by viewing the “Older Versions” of these documents.
Should you have any questions, please contact Elena Gonikberg, Sr. Principal Scientist (eg@usp.org).
CN-23-033-00