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

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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).


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