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).
|
