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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Evaluating Impurities in Drugs (Part III of III)
In Part III of a three-part article, the authors examine various degradation routes of APIs, impurities arising from interactions in formulations, metabolite impurities, various analytical methods to measure impuritie, and ways to control impurities.


Pharmaceutical Technology
Volume 36, Issue 4, pp. 76-86

References

1. K.R. Wadekar et al., Pharm. Technol. 36 (2), 46–51 (2012).

2. K.R. Wadekar et al., Pharm. Technol. 36 (3), 58–70 (2012).

3. ICH, Q1A (R2) Stability Testing of New Drug Substances and Products (Nov. 2003).

4. ICH, Q3A(R) Impurities in New Drug Substances (Feb. 2003).

5. ICH, Q3B (R) Impurities in New Drug Products (Nov. 2003).

6. ICH, Q3C (R5), Impurities: Guideline for Residual Solvents (March 2011).

7. K.M. Alsante et al., Am. Pharm. Rev. 4 (1), 70–78 (2001).

8. T.R. Sharp, Am. Pharm. Rev. 9 (7), 84–91 (2006).

9. T.R. Sharp, Am. Pharm. Rev. 9 (3), 100–105 (2006).

10. J.A. Mollica et al., J. Pharma. Sci. 67 (4), 443–465 (1978).

11. S. Ahuja, Impurities Evaluation of Pharmaceuticals (Marcel Dekker, New York, 1998)

12. L. Gu et al., Int. J. Pharm. 41 (1–2) 105–113 (1988).

13. P.V. Devarajan et al., J. Pharm. Biomed. Anal. 22 (4), 679–683 (2000).

14. M.C. Damle et al., J. Adv. Sci. Res. 2 (3), 77-82 (2011).

15. K.A. Connors, G.L. Amidon, and V. J. Stella, Chemical Stability of Pharmaceuticals—A Handbook for Pharmacists (John Wiley & Sons, New York, 1986).

16. J. Roy et al., J. Pharm. Sci. 90 (5) 541–544 (2001).

17. G.J.A. Walker et al., Lancet 13 (2), 393–393, (1988).

18. H.V. Hogerzeil et al., British Medical Journal 304 (25), 210–212 (1992).

19. J. Roy et al., Indian Drugs 34 (11), 634–636 (1997).

20. J. Roy et al., Drug Dev. Ind. Pharm. 20 (13), 2157–2163 (1994).

21. P.S. Rao et al., J. Pharm. Biomed. Anal. 56 (2) 413–418, (2011).

22. E. Fasani et al., Photochem. Photobiol. 68 (5) 666–674 (1998).

23. K. M Alsante et al., J. Pharm. Sci. 93 (9) 2296-2309 (2004).

24. W. Steven et al., J. Pharm. Sci. 97 (2) 883–892 (2008).

25. S.W. Baertschi et al., Pharm. Technol. 26 (2) 48–54 (2002).

26. J. Tagg et al., Biochem. Pharmacol. 16 (1) 143–153 (1967).

27. F.M. Eckenrode, J. Nat. Prod. 47 (5) 882–884 (1984).

28. J.M. Bowen et al., Anal. Chem. 53 (14) 239–2242 (1981).

29. M. Colvin, Clin. Pharmacokinetics 4 (5) 380-394 (1979).

30. Z. H. Israili et al., J. Pharmacol. Exp. Ther. 187 (1) 138–151 (1973).

31. M.A. Schwartz. et al., Drug Metab. Dispos. 1 (1) 322–331 (1973).

32. K. Kassahun et al., Drug Metab. Dispos. 1 (25) 81–93 (1996).

33. E. Stoermer et al., Drug Metab. Dispos. 10 (28) 1168–1175 (2000).

34. J. G. Slatter et al., Drug Metab. Dispos. 8 (29) 1136–1145 (2001).

35. S. Ahuja, Chromatography of Pharmaceuticals—Natural, Synthetic and Recombinant Products, ACS Symposium Series 512 (American Chemical Society, Washington, DC, 1992).

36. S. Ahuja, Trace and Ultratrace Analysis by HPLC (John Wiley & Sons, New York, 1992).

37. S. Ahuja, Chromatography and Separation Science (Elsevier, 2003).

38. S. Ahuja and S. Scypinski, Eds., Handbook of Modern Pharmaceutical Analysis (Academic Press, 2001).

39. S. Ahuja and M.Dong, Eds., Handbook of Pharmaceutical Analysis by HPLC: Volume 6 (Academic Press, 2005).

40. J. Roy et al., Indian Drugs 34 (11) 634–636 (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.
28%
Oversee medical treatment of patients in the US.
11%
Provide treatment for patients globally.
9%
All of the above.
46%
No government involvement in patient treatment or drug development.
7%
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
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
Source: Pharmaceutical Technology,
Click here