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
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
38%
Breakthrough designations
13%
Protecting the supply chain
38%
Expedited reviews of drug submissions
13%
More stakeholder involvement
0%
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
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
USP Faces New Challenges
Source: Pharmaceutical Technology,
Click here