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

Need for modernization

Incidences of intentional adulteration have increased in recent years, and adulteration has become a major concern as supply chains continue to expand globally. Intentional adulteration can include the dilution of expensive fixed-oil products with cheaper substances.

Because of incidences of intentional adulteration in almond oil, in 2004 stakeholders provided USP with supporting data and requested the inclusion of a sterol composition specification in the Almond Oil NF monograph to combat adulteration. The supporting data demonstrated that compliance with the existing NF specifications in USP 28–NF 23 (2005) (3) did not guarantee the purity and authenticity of almond oil. In 2005, USP staff and the Excipient Monographs 2 (EM2) Expert Committee (EC) started to revise the Almond Oil NF monograph. Historical data in the Almond Oil NF monograph revision files indicated that this monograph had not been updated since the 1960s. Reports included in the revision files showed that Almond Oil NF adulterated with 10% to 25% of a cheaper oil or almond oil mixed with persic oil (1:1) still could pass NF 23 (2005) tests and meet all acceptance criteria, and thus the material erroneously could be considered to be in compliance with NF 23 specifications.

During the previous 2005−2010 revision cycle, EM2 EC concluded that the fixed-oil NF 23 compendial specifications required revisions because they had not kept pace with industry practices, specifically with respect to oil manufacturers’ current quality control practices in releasing and characterizing oil substances (4). USP−NF standards not only facilitate trade by establishing a baseline for product quality that is internationally agreed upon, but, most importantly, the public standards also ensure performance of drug formulations and add assurance of drug and excipient safety, thereby protecting public health.

In the United States under the Federal Food, Drug, and Cosmetic Act (FDCA), both USP and NF are recognized as official compendia. USP−NF is continuously revised. Compendial standards in existence for a long period of time may require updates to keep pace with current regulatory and safety requirements and to incorporate advances in analytical methodology and metrological science. The modernization replaces outdated and nonspecific methodology with analytical procedures that provide improved specificity, accuracy, precision, and sensitivity and are less laborious and less time-consuming. Such methods make it possible to demonstrate whether or not an excipient meets the acceptance criteria and is suitable for its intended use, particularly when the excipient must meet a stringent safety regulatory requirement (e.g., for parenteral or inhalation use).

Specifications for a particular excipient can change over time. Such changes usually occur with the introduction of improved quantitation methods that are universally adopted, typically because they are more sensitive and selective or can simultaneously detect multiple analytes. Changes to specifications also are necessary to enhance public standards’ usefulness in preventing intentional adulteration (5).


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