Type of Posting: General Announcement
Posting Date: 24–April–2020; updated 26–Jun–2020*
Expert Committee: Excipient Monographs 1
Based on comments received, the Excipient Monographs 1 Expert Committee has split a previously unified monograph for Glyceryl Monocaprylocaprate into two separate monographs:
- Glyceryl Monocaprylocaprate, and
- Glyceryl Mono and Dicaprylocaprate
The revised monograph for Glyceryl Monocaprylocaprate contains the procedures and limits specified for Glyceryl Monocaprylocaprate Type II. The new monograph for Glyceryl Mono and Dicaprylocaprate contains the procedures and limits specified for Glyceryl Monocaprylocaprate Type I.
Both revisions were proposed in Pharmacopeial Forum (PF) 44(5) and were targeted to become official on May 1, 2020, with a 60-month implementation period for the title changes. The 60-month implementation period is intended to provide the time necessary for labeling changes to be made for the article and the numerous preparations in which it is an ingredient, as well as for practitioners, consumers, and regulatory agencies to become familiar with the new terminology.
Any article currently titled Glyceryl Monocaprylocaprate Type I will be officially titled Glyceryl Mono and Dicaprylocaprate after May 1, 2025. Any article currently titled Glyceryl Monocaprylocaprate Type II will be officially titled Glyceryl Monocaprylocaprate after May 1, 2025.
Please note that although the official dates for standards published as final approved text in USP 43–NF 38 have been extended by six months from May 1, 2020 to November 1, 2020 (see this Notice), the official dates associated with the title changes for these monographs remain unchanged. The 60-month implementation period means the new titles will become official on May 1, 2025.
The previously unified monograph for Glyceryl Monocaprylocaprate specified the use of a Reference Standard (RS) labeled USP Glyceryl Monocaprylocaprate RS (Type I). The two separate monographs for Glyceryl Monocaprylocaprate and Glyceryl Mono and Dicaprylocaprate specify the use of USP Glyceryl Mono and Dicaprylocaprate RS. During the 60-month implementation period for the monograph title changes, both RS names will appear in the monographs, as customers may encounter both names on RS labels. The alternative names for the RS are indicated as a Note in the USP Reference Standards <11> section of each monograph, as follows:
USP Glyceryl Mono and Dicaprylocaprate RS
[NOTE – May also be labeled as USP Glyceryl Monocaprylocaprate RS (Type I) until May 1, 2025]
Should you have any questions, please contact Peng Zhang, Scientific Liaison to the Excipient Monographs 1 Expert Committee (301-692-3454, or PGZ@usp.org).
CN-20-053-01
* This notice was updated on June 26, 2020 to provide reference to the official date extension for standards published as final approved text in USP 43–NF 38.