Organic Impurities in Drug Substance: Origin, Control, and Measurement

Analysis of Drug Impurities

Volumn , Issue , 2007, Pages 1-20

  Ng, Linda ^a   Lunn, George ^a   Faustino, Patrick ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Contamination impurities; Degradation impurities; Drug substance; Organic impurities; Process impurities

Indexed keywords

EID: 84866265077     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470988749.ch1     Document Type: Chapter

References (20)

1. USPharmacopeia 29/National Formulary 24, 1086, Rockville, MD, 2006, p. 2921.
2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH S6: Preclinical Safety Evaluation of Biotechnologyderived Pharmaceuticals, 1997.
3. J. Bauer, S. Spanton, R. Henry, et al., Pharm. Res., 2001, 18, 859-866.
4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, 1999.
5. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, 1999.
6. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Q3C(R3): Impurities: Residual Solvents, 2005.
7. D. D. Wirth, B. A. Olsen, D. K. Hallenbeck, M. E. Lake, S. M. Gregg and F. M. Perry, Chromatographia, 1997, 46, 511-523.
8. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Q3A(R1): Impurities in New Drug Substances, 2002.
9. USPharmacopeia 29/National Formulary 24, Rockville, MD, 2006, p. 828.
10. USPharmacopeia 29/National Formulary 24, Rockville, MD, 2006, p. 157.
11. J. Paesen, E. Roets and J. Hoogmartens, Chromatographia, 1991, 32, 162-166.
12. R. Grahek, D. Milivojevic, A. Bastarda and M. Kracun, J. Chromatogr. A, 2001, 918, 319-324.
13. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Q7A: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, 2000.
14. G. Xue, A. D. Bendick, R. Chen and S. S. Sekulic, J. Chromatogr. A, 2004, 1050, 159-171.
15. R. Otero, G. Carrera, J. F. Dulsat, J. L. Fábregas and J. Claramunt, J. Chromatogr. A, 2004, 1057, 193-201.
16. K. J. Mulligan, T. W. Brueggemeyer, D. F. Crockett and J. B. Schepman, J. Chromatogr. B, 1996, 686, 85-95.
17. S. Zaugg and W. Thormann, J. Pharm. Biomed. Anal., 2001, 24, 785-799.
18. C. L. Flurer and K. A. Wolnik, J. Chromatogr. A, 1994, 674, 153-163.
19. FDA/CDER Reviewer Guidance: Validation of Chromatographic Methods, November 1994, p. 23 (http://www.fda.gov/cder/guidance/index.htm).
20. FDA/CDER Reviewer Guidance: Validation of Chromatographic Methods, November 1994, p. 9 (http://www.fda.gov/cder/guidance/index.htm).