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

30. F.J. Jamali, J. Pharm. Sci. 78 (9), 695–715 (1989).

31. "FDA's Policy Statement for the Development of New Stereoisomer Drugs," Chirality 4 (5), 338–340 (1992).

32. H. Wilson et al., J. Pharm. Biomed. Anal. 11 (11–12), 1167–1173 (1993).

33. A.G. Rauws, Chirality 6 (2), 72–75 (1994).

34. M. Gross et al., Drug Inf. J. 27 (2), 53–457 (1993).

35. W.L. Heydorn, Pharm. News 2, 19–21 (1995).

36. ICH, Q6A Document, Specification for New Drug Substances and Products: Chemical Substances, Step 2 version (1992).

37. J. Haleblian et al., J. Pharm. Sci. 58 (8) 911–929 (1969).

38. G.A. Stephenson et al., Adv. Drug. Deliv. Rev. 48, 67–90 (2001).

39. ICH, Q6A Specification: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (1999).

40. G.G. Z. Zhang et al., Adv. Drug Deliv. Rev. 56 (3), 371–390 (2004).

41. S.R. Vippagunta et al., Adv. Drug Deliv. Rev. 48 (1), 3–26 (2001).

42. P.B. Molinoff, The Pharmacological Basis of Theraputics (McGraw Hill, New York, 1996), pp. 399–430.

43. S.M. Reutzel-Edens, Cryst. Growth Des. 3 (6) 897–907 (2003).

44. Eli Lilly, "Olanzapine Polymorph Crystal Form,"US Patent 5,736,541 (April 1998).

45. H.Y. Tong et al., Pharm. Res. 18 (6), 852–858 (2001).

46. H.H. Tong et al., Pharm.Res. 20 (9), 1423–1429 (2003).

47. D. Clemett et al., Drugs 59 (4), 815–827 (2000).

48. Teva Pharmaceutical Industries, "Isolated Bis-Linezolid, Preparation Thereof and Its Use as a Reference Standard, WO 2006/091848 A2, Aug. 2006.

49. Neuland Laboratories, "A Process for the Preparation of (5S)-(N)-[[3-[3-fluoro-4-4(4-morpholinly)phenyl-2-oxo-5-oxazolidinyl]methyl] acetamide," WO2010084514A2, July 2010.

50. Symed Labs, "Novel Process for the Preparation of Linezolid and Related Compounds," US Patent 2007/0032472, Feb, 2007.

51. B. A. Peralman, "Process to Produce Oxazolidiones," US Patent 2002/0095054, July 2002.

52. Pfizer, "Process for Preparing Linezolid," WO 2007/116284, Oct. 2007.

5 3. Pharmacia & Upjohn, "Process to Prepare Oxazolidinones," US Patent 5837870, Nov. 1998.

54. Jubilant Life Sciences, "Process for the Preparation of Linezolid," WO 2011/114241, Sept. 2011.

55. Pharmacia and Upjohn, "Substituted Oxazine and Thiazine Oxazolidinone Antimicrobials," US Patent 5688792, Nov. 1997.

56. D.C.M Chan et al., Curr. Med. Chem. 13 (4), 377–398 (2006).

57. Fortress Metro Hainan Tianyuan Pharmaceutical Technology Co., Ltd., "Nitro Compounds and the Preparation of Pemetrexed CN1827604A, Sept. 2006.

58. Wu Torrent, "Pemetrexed Intermediates and Preparation Methods, CN101085775A, Dec. 2007.

59. Dr. Reddy's Laboratories, "Process for Preparing Pemetrexed, WO 2011/019986 A2, Feb. 2011.


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