Fixed-Oil Excipient Monographs: Development of USP Fixed-Oil Reference Standards - Pharmaceutical Technology

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Fixed-Oil Excipient Monographs: Development of USP Fixed-Oil Reference Standards
This article summarizes the development and modernization of the United States Pharmacopeia-National Formulary (USP-NF) fixed-oil excipient monographs. This article contains bonus online-exclusive material.

Pharmaceutical Technology
Volume 37, Issue 4, pp. 102-108

Table XI: Continued monograph modernization for fixed oils.
Conclusion and future development and modernization As shown in Table XI, excipient monograph modernization is a continuing endeavor that requires a consistent approach within a family of excipients. Such an approach is necessary to streamline analytical testing across multiple monographs as well as to keep the number of specific analytical tests to a minimum. This decreases the analytical burden on industry and allows methods to be referenced in monographs (e.g., from a general chapter).

USP continues to update USP−NF to provide standards for articles, including revised specifications based on advances in analytical and metrological science. USP ECs also rely on stakeholders’ and sponsors’ comments to keep monographs current. Emerging methodologies such as carbon number testing, C13/C12/ratio testing, and chemometrics can be considered as they become commonly adopted by stakeholders.


The authors would like to thank USP visiting scientists Hua Yin, MS (Chinese Pharmacopoeia) and Cheetham Mingle, MS (Food and Drug Board, Ghana) for their contributions to the monograph modernization projects for almond oil and castor oil, respectively. USP laboratory staff (Samir Z. Wahab; Patricia White (retired); Shane X. Tan; MinLi Liu; Johanna M. Smeller; Zarema K. Kassymberk; Eduardo R. Lim; Kornepati V. Ramakrishna; David C. Parmelee; Karen V. Gilbert; and Nadejda V. Soukhova) are acknowledged for their support in updating the documentary standards. The authors thank Stefan Schuber, PhD, MS, ELS, of USP for editorial assistance.


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