Impurity profile tracking for active pharmaceutical ingredients: Case reports

Journal of Pharmaceutical and Biomedical Analysis

Volumn 44, Issue 2, 2007, Pages 421-429

  Zhou, Lili ^a   Mao, Bing ^a   Reamer, Robert ^a   Novak, Tom ^a   Ge, Zhihong ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Active pharmaceutical ingredient (API); Elucidation of impurity structures; Impurity profile tracking; Peak purity check; Reversed phase high performance liquid chromatographic (RP HPLC)

Indexed keywords

CATHEPSIN K INHIBITOR; GROWTH HORMONE SECRETAGOGUE; IBUTAMOREN; MUSCARINIC RECEPTOR BLOCKING AGENT;

ARTICLE; DRUG IMPURITY; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; NUCLEAR MAGNETIC RESONANCE; PRIORITY JOURNAL; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY;

CATHEPSINS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG CONTAMINATION; DRUG INDUSTRY; ENZYME INHIBITORS; HUMAN GROWTH HORMONE; HYDROGEN-ION CONCENTRATION; INDOLES; MUSCARINIC ANTAGONISTS; PHARMACEUTICAL PREPARATIONS; RECEPTOR, MUSCARINIC M3; SPECTROPHOTOMETRY, ULTRAVIOLET; SPIRO COMPOUNDS;

EID: 34249936489     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2006.11.004     Document Type: Article

References (12)

1. Proceedings of the International Conference for Harmonization Q3A(R). Impurities in New Drug Substances, February 2002.
2. Snyder L.R., Kirkland J.J., and Glajch J. Practical HPLC Method Development. 2nd ed. (1997), Wiley & Sons, New York pp. 537-541
3. Görög S. T. Anal. Chem. 25 (2006) 755-757
4. Gyseghem E.V., Jimidar M., Sneyers R., Smet M.D., Verhoeven E., and Heyden Y.V. J. Pharm. Biomed. Anal. 41 (2006) 751-762
5. Xue G., Bendick A.D., Chen R., and Sekulic S.S. J. Chromatogr. A 1050 (2004) 159-171
6. Mistry N., Ismail I.M., Farrant R.D., Liu M., Nicholson J.K., and Lindon J.C. J. Pharm. Biomed. Anal. 19 (1999) 511-517
7. Mase T., Houpis I.N., Akao A., Dorziotis I., Emerson K., Hoang T., Iida T., Itoh T., Kamei K., Kato S., Kato Y., Kawasaki M., Lang F., Lee J., Lynch J., Maligres P., Molina A., Nemoto T., Lkada S., Reamer R., Song J.Z., Tschaen D., Wada T., Zewge D., Volante R.P., Reider P.J., and Tomimoto K.J. J. Org. Chem. 66 (2001) 6775-6786
8. Smith R.G., Chang K., Schoen W.R., Pong S., Hicky G., Jacks T., Butler B., Chan W., Chaung L., Judith F., Taylor J., Wyvratt M.J., and Fisher M.H. Science 260 (1993) 1641-1648
9. Setti E., Venkatraman S., Palmer J.T., Xie X., Cheung H., Yu W., Wesolowski G., and Robichaud J. Bioorg. Med. Chem. Lett. 16 (2006) 4296-4299
10. Hargis L.G. Analytical Chemistry Principles and Techniques. 1st ed. (1988), Prentice-Hall, Inc., New Jersey pp. 223-225
11. Zhou L., Wu Y., Johnson B.D., Thompson R., and Wyvratt J.M. J. Chromatogr. A 866 (2000) 281-289
12. Agilent 1100 Series Diode Array and Multiple Wavelength Detectors Reference Manual (2000), Agilent Technologies, Germany pp. 56-57