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

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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
29%
Breakthrough designations
10%
Protecting the supply chain
43%
Expedited reviews of drug submissions
10%
More stakeholder involvement
10%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here