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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
26%
Oversee medical treatment of patients in the US.
13%
Provide treatment for patients globally.
11%
All of the above.
39%
No government involvement in patient treatment or drug development.
11%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology,
Click here