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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Evaluating Impurities in Drugs (Part II of III)
In Part II of a three-part article, the authors examine impurities from chiral molecules, polymorphic contaminants, and genotoxic impurities.


Pharmaceutical Technology
Volume 36, Issue 3, pp. 58-72

References

1. FDA, Guidance for Industry—ANDAs: Impurities in Drug Products (Rockville, MD, Aug. 2005).

2. FDA, Guidance for Industry—ANDAs: Impurities in Drug Substances (Rockville, MD, Jan. 2005).

3. S. Görög, Identification and Determination of Impurities in Drugs (Elsevier Science, Amsterdam, 2000).

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

5. S. Hovorka and C. Schöneich, J. Pharm.Sci. 90 (3), 253–269 (2001).

6. J. Roy, AAAPS PharmSciTech 3 (2), 1–8 (2002).

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

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

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

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

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

12. B.C. Allen, K.S Crump, and A.M. Shipp, Risk Anal.8 (4), 531–544 (1988).

13. S.W. Baertschi and D.W. Reynolds, "Introduction" in Pharmaceutical Stress Testing: Predicting Drug Degradation, J. Swarbick, Ed. (Taylor & Francis, New York, 2005), pp. 4–8.

14. S. Ahuja, Chiral Separations by Chromatography (Oxford University Press, New York, 2000).

15. S. Ahuja, Chiral Separations by Liquid Chromatography, ACS Symposium Series 471 (American Chemical Society, Washington, DC, 1991).

16. J. Trofast et al., Chirality 3 (6), 443–450 (1991).

17. B. Waldeck, Chirality 5 (5) 350–355 (1993).

18. L. Gillespie et al., Circulation 25, 281–291 (1962).

19. H. Kubota et al., Chem. Pharm. Bull. 40, 1619–1622 (1992).

20. R.B. Carter, J. Pharmacol. Exp. Ther. 234 (2), 299–306 (1985).

21. Chiral Agonists of Histamine in Fornitier in Histamine Research (Oxford, 1985), pp.39-46.

22. M.E. Goldman et al., J. Mol. Pharmacol. 25 (1), 18–23 (1984).

23. W.M. Welch et al., J. Med. Chem. 27 (11), 1508–1515 (1984).

24. B.K. Koe et al., J. Pharmacol. Exp. Ther. 226 (3), 686–700 (1983).

25. T. de Boer et al., Chromatogr. 26 (2), 156–165 (2012).

26. TGA, Australian Public Assessment Report for Asenapine (Woden, Australia, April 2011).

27. S.G. Allenmark, Chromatographic Enantioseparation: Methods and Applications (Ellis Horwood, Chichester, 1991).

28. G. Gubitz, Chromatographia 30, 555–564 (1990).

29. D.E. Drayer, Clin. Pharmacol. Ther. 40 (2), 125–133 (1986).


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.
26%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
10%
All of the above.
43%
No government involvement in patient treatment or drug development.
10%
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
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology,
Click here