Evaluating Impurities in Drugs (Part I of III) - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Evaluating Impurities in Drugs (Part I of III)
In Part I of a three-part article, the authors discuss what constitutes an impurity and the potential sources of impurities in APIs and finished drug products.


Pharmaceutical Technology
Volume 36, Issue 2, pp. 46-51

References

1. FDA, Guideline for Submitting Supportive Documentation in Drug Applications for the Manufacture of Drug Substances (Rockville, MD, Feb. 1987).

2. ICH, Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Step 5 (Nov. 2000).

3. FDA, Draft Guidance for Industry: Drug Substance: Chemistry Manufacturing and Controls Information (Rockville, MD, Jan. 2004).

4. T. Cupps et al., Pharm. Technol. 27 (2), 34–52 (2003).

5. M. Johnson, Med. Res. Rev. 15 (3), 225–257 (1995).

6. A.T. Nials et al., Am. Rev. Resp. Dis. 149, A481 (1995).

7. Y Kawakami et al., Eur. J. Med. Chem. 31 ( 9), 683–692 (1996).

8. N.O. Mahmoodi and M. Jazayri, Syn. Comm. 31 (10), 1467–1476 (2001).

9. M. Islam et al., Acta Poloniae Pharm. Drug Res., 65 (4) 441–447 (2008).

10. K.T. Chapman et al., Bioorg. Med. Chem. Lett. 6 (7), 803–806 (1996).

11. A.A. Siddiqui et al., Bioorg. Med. Chem. Lett. 21 (3), 1023–1026 (2011).

12. B. Venkatasubbaiah et al., Scientia Pharm. 77, 579–587 (2009) .

13. J.J. Hale et al., J. Med. Chem. 41 (1), 4607–4614 (1998).

14. K.M. Alsante, Amer. Pharm. Rev. 4 (1) 70–78 (2001).

15. J. Zsindely et al., Helv. Chim. Acta 51, 1510 (1968).

16. J.D. Hayler et al., Org. Process Res. Dev. 2 (1), 3–9 (1998).

17. J. Swanston, "Thiophene" in Ullmann's Encyclopedia of Industrial Chemistry, (Wiley-VCH, Weinheim, Germany, 2006).

18. Tel-Aviv University, "Novel Psychotropic Agents Having Glutamate NMDA Activity," WIPO Patent WO2008/50341, May 2008.

19. Watson Pharmaceuticals, "2-Methyl-thieno-benzodiazepine Process," WIPO Patent WO2004/94390, Nov. 2004.

20. Shastri et al., "Process for Producing Pure Form of 2-Methyl-4-(4-Methyl-1-Piperazinyl)-10H-Thieno[2,3-b] [1,5]Benzodiazepine," US Patent 2009/5556, Jan. 2009.

21. Eli Lilly, "Process for Preparing 2-Methyl-thieno-benzodiazepine" US Patent 6008216, Dec. 1999.

22. Lilly Industries, "2-Methyl-thieno-benzodiazepine," US Patent 5229382, July 1993.

23. Eli Lilly, "2-Methyl-thieno-benzodiazepine," US Patent 5605897, Feb. 1997.

24. X He et al., J. Pharm. Sci. 90 (3) 371–388 (2001).

25. V.P. Shevchenko, Russian J. Bioorg. Chem. 31 (4), 378–382 (2005).

26. V.P. Shevchenko, Bioorganicheskaya Khimiya 31 (4) 420–424 (2005).

27. J.C. Dunham et al., Synthesis, 4, 680–686 (2006).

28. A.H. Elgandour et al., Indian J. Chem. Sec. B: 36 (1) 79–82 (1997).

29. R. Mariella and A. Roth, J. Org. Chem. 22 (9), 1130 (1957).

30. Hart and Freeman, Chemistry and Industry, p. 332 (1963).

31. Da-Zhen Xu et al., Green Chem. 12 (3) 514–517 (2010).

32. H.C. Brown and M.V. Rangaishenvi, J. Heterocycl. Chem. 27 (1), 1–12 (1990).

33. S. Fioravanati, Synlett. (6), 1083–1085 (2004).

34. V.D. Dayachenko, J. Gen. Chem. 74 (7), 1135–1136 (2004).

35. Zhurnal Obshchei Khimii 74 (7), 1227–1228 (2004).

36. V.D. Dayachenko and A.N. Chernega, Russian J. Org. Chem. 42 (4), 567–576 (2006).

37. Zhurnal Organicheskoi Khimii 42 (4), 585–593 (2006).

38. D.L.K. Marotti et al., AntiMicrob. Agents Chemother. 41 (10), 2132–2136 (1997).

39. E.Z. Gray et al., Expert Opin. Investig. Drugs 6 (2), 151–158 (1997).


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.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here