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

Appendix

Iodine Value



The formula to estimate the iodine value from the Fatty Acid Composition profile (15–17) is:

where

IVmixture = iodine value

PFA = percentage of a fatty acid determined from the Fatty Acid Composition (%)

MW(2I) = atomic weight of two iodine atoms that are theoretically added to one double bond, 253.81

Ndb = number of double bonds

MW(FA) = molecular weight of the fatty acid.

The calculated iodine values for oleic acid, linoleic acid, linolenic acid (each with purity < 99%) using the equation above are 89.9, 181.0, and 237.5, respectively.

Saponification Value

The formula to estimate the saponification value from the Fatty Acid Composition profile (15,17) is:




For triglycerides

where

SVmixture = saponification value

PFA = percentage of a fatty acid determined from the Fatty Acid Composition (%)

MW(KOH)= molecular weight of potassium hydroxide, 56.11

MW(FA) = molecular weight of the fatty acid

MW(Glycerin) = molecular weight of glycerin, 92.09

MW(H2O) = molecular weight of water, 18.02.

About the Authors

Hong Wang* is senior scientific liaison at USP, Rockville, MD, hw@usp.org. Catherine Sheehan is director, excipients, USP. Lawrence H. Block (chair), Richard C. Moreton (vice-chair), Richard H. Wendt, Shireesh P. Apte, and Eric J. Munson are members of the USP 2010–2015 Monographs—Excipients Expert Committee.

*To whom all correspondence should be addressed.


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