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

Test specifications: Iodine Value, Saponification Value, and some other physical methods. Iodine Value and Saponification Value. Iodine Value and Saponification Value are used to measure the degree of unsaturation and the relative proportions of fatty acids and glycerin in a sample, respectively. Introducing the Fatty Acid Composition test into the monograph makes the Iodine Value and Saponification Value redundant because both values can be estimated from the Fatty Acid Composition profile (see Appendix 1). Therefore, when the Fatty Acid Composition test is part of the specifications of a fixed-oil monograph, the Iodine Value and Saponification Value usually are not included or have been deleted from the monograph.

The iodine and saponification values for each USP−NF fixed-oil included in USP 31–NF 26 (2008) (27) are summarized in Table VIII.

Other Physical Tests. Other tests such as Specific Gravity and Refractive Index that previously were included in several fixed oil monographs have been moved into the Description and Solubility section of USP−NF for the fixed oils. With the proposed modernization for the fixed oils, these physical tests provide added optional assurance of identification and purity of the fixed oils.

Table IX: Newly developed and modernized oil monographs.
Monograph development and modernization status. From May 2005, USP staff and EM2 EC worked with FDA, USP Research and Development laboratories, and stakeholders during the 2005–2010 revision cycle to develop and modernize many fixed-oil monographs. Except for the newly proposed general chapter <202>, EM2 EC followed a strategic analytical plan for fixed oils (see Table IV) and developed eight new oil monographs and modernized six existing ones. All became official during the previous revision cycle (2005–2010) and were adopted into USP–NF. A list of the oil monographs developed and modernized during the 2005−2010 revision cycle is provided in Table IX.

Table X: Modernized Olive Oil NF in USP 33–NF 28 Reissue (Ref. 7).
Table X displays the Olive Oil NF monograph modernized by following the guidelines in Table IV, except for the newly proposed chapter <202>.

With the introduction of new test chapter <202>, EXC EC will re-evaluate fixed oils and will continually revisit the modernization projects for fixed oil monographs. Recently, stakeholders requested USP to improve the Sterol Composition for Soybean and Olive Oil. The oil manufacturer recommended that the procedure for separation of sterol by TLC be replaced by a separation procedure using preparative HPLC to avoid cross-contamination by the TLC plate coating. The preparative HPLC method improves precision and reproducibility. Fixed oil modernization proposals will be published in future PFs (see Table XI for a list of on-going modernization projects).


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