Will the library be available to everyone?
The agency does not plan to share the library at this time. If industry and the agency see value in sharing the library in
the future, FDA will conform to any provisions in the MTAs.
Will others be able to contribute to the spectral library?
FDA prefers to obtain excipients directly from manufacturers or distributors to be certain of their identity and provenance
of the manufacturer and/or manufacturing site to minimize the possibility that a contaminated or subpar quality excipient
is included in the library. As far as contributing spectral entries into the spectral database, FDA will not be accepting
spectra.
How will the materials be used and/or evaluated?
Both Raman and NIR spectra of the excipients received will be generated without further testing or qualification of the material.
As the scope of this effort is to establish a spectral library database, FDA does not plan to perform quality testing.
Would there be a time factor for the samples (i.e., would the manufacturer need to send samples every year)?
For most samples, this step would not be required. However, manufacturers could send new samples if they felt a process or
raw material change could affect the spectrum of their material.
Acknowledgments
John Kauffman, Jason Rodriguez, Steve Wolfgang, William Busch, Karen Richardson, Chris Moreton, Patrick Rice, Ken Crook, Chi-san
Wu, Asenicion Koenig, Carl Perini, Bret Clark, Justin Denault, Irwin Silverstein, Priscilla Zawislak, Art Falk, Dale Carter,
Dave Schoneker, Alan Potts.
Lucinda F. Buhse is director of the Division of Pharmaceutical Analysis in FDA's Office of Testing and Research. Philip H. Merrell is a subcommittee chair at the International Pharmaceutical Excipients Council of the Americas and a technical market manager
at Jost Chemical, tel. 314.428.4300.
References
1. D.M. Autor, FDA, presentation given at DCAT Week, New York, Mar. 18, 2009.
2. J. Taylor, III, FDA, presentation given at Pew Health Group Conference, Washington DC, Mar. 14, 2011.
3. J.F. Kauffman et al., Amer. Pharm. Rev.
13, 58–64 (2010) .
4. S. Arzhantsev, X. Li, and JF Kauffman, Analyt. Chem.
83, 1061–1068 (2011).
5. C.M. Gryniewicz-Ruzicka et al., Appl. Spectrosc.
65, 334–341 (2011).
6. J.D. Dunn et al., Jrnl. of Pharm. Sci.
54, 469–474 (2011).
7. X. Li, S. Arzhantsev, J.F. Kauffman, and J.A. Spencer, Jrnl. of Pharm. and Biomed. Anal.
54, 1001–1006 (2011).
8. J.F. Kauffman, L.F. Buhse, and J.D. Rodriguez, Amer. Pharm. Rev., in Press (2011).
9. J.D. Rodriguez, B.J. Westenberger, L.F. Buhse, and J.F. Kauffman, The Analyst, in revision (2011).
10. J.D. Rodriguez, B.J. Westenberger, L.F. Buhse, and J.F. Kauffman, Analyt. Chem.,
83, 4061–4067 (2011).
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