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

REFERENCES

1. USP, USP 35–NF 30 through First Supplement (US Pharmacopeia Convention, Rockville, MD, 2012).

2. USP, USP 35−NF 30 General Notices 5.20. Added Substances. (US Pharmacopeia Convention, Rockville, MD, 2012).

3. USP, USP 28–NF 23, (USP, Rockville, MD, 2005).

4. Alander J, Andersson AC, Bagge C, et al. Handbook of Vegetable Oils and Fats. 2nd ed. (Karlshamn, Sweden: AarhusKarlshamn; 2007).

5. Bell JR, Gillatt PN, Standards To Ensure The Authenticity Of Edible Oils And Fats, (1994), www.fao.org/docrep/T4660T/t4660t0e.htm. Accessed 13 December 2012.

6. USP, USP 32–NF 27 (US Pharmacopeia Convention, Rockville, MD, 2009).

7. USP, USP 33–NF 28 Reissue (US Pharmacopeia Convention, Rockville, MD, 2010).

8. 21 CFR 211.84.

9. Belitz HD, Grosch W, Schieberle P. Food Chemistry. 3rd ed. (New York: Springer; 2004).

10. USP, Monograph modernization. 2012. www.usp.org/usp-nf/development-process/monograph-modernization, accessed December 13, 2012.

11. USP, Fats and Fixed Oils <401>, Pharmacopeial Forum, 34(3), 736–747 (2008).

12. USP, Fats and Fixed Oils <401>, Pharmacopeial Forum, 31(4), 1157 (2005).

13. USP, Fats and Fixed Oils <401>, Pharmacopeial Forum, 32(5):1492–1493 (2006).

14. USP, Fats and Fixed Oils <401>, Pharmacopeial Forum, 29(4):1145–1146 (2003).

15. G. Knothe, J Am Oil Chem Soc. 79, 847–854 (2002).

16. AOCS, AOCS recommended practice Cd 1c-85, calculated iodine value. In: Firestone D, ed. Official Methods and Recommended Practices of the American Oil Chemists’ Society. 5th ed. Champaign, IL: AOCS (1998).

17. AOCS, “AOCS Recommended Practice Cd 3a-94, Calculated Saponification Value,” In: Official Methods and Recommended Practices of the American Oil Chemists’ Society. 5th ed., Firestone D, ed., Champaign, IL: AOCS (1998).

18. USP, Injections <1>, Pharmacopeial Forum, 34(4):1020 (2008).

19. LH Block et al., Pharmacopeial Forum. 37(3) (2011).

20. MD Guillen and A. Ruiz, J Sci Food Agric. 83, 338−346 (2003).

21. B. Fuchs et al., J Chromatogr A. 1218, 2754–2774 (2011).

22. USP, Lecithin, Pharmacopeial Forum, 38(6) (US Pharmacopeia Convention, Rockville, MD, 2012).

23. USP, Identification of Fixed Oils by Thin-layer Chromatography <202>, Pharmacopeial Forum. 39(1) (US Pharmacopeia Convention, Rockville, MD, 2013). 24. EP, PhEur. 7th ed. Strasbourg, France: European Directorate for the Quality of Medicines and Health Care (2012).

25. Salimon J, et al, A. Sains Malaysiana. 39(5), 761−764 (2010).

26. USP, USP 36–NF 31 (US Pharmacopeia Convention, Rockville, MD, 2013).

27. USP, USP 31–NF 26 (US Pharmacopeia Convention, Rockville, MD, 2008).


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