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

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 FDA, Draft Guidance for Industry: Drug Substance: Chemistry Manufacturing and Controls Information (Rockville, MD, Jan. 2004).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


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