This study demonstrates the general applicability of handheld Raman spectroscopy for pharmaceutical raw material identification
through extensive characterization of method performance for 198 raw materials commonly used in the pharmaceutical and related
industries. Method development required only one sample of each material. In nearly 40,000 method challenges, a 100% correct
positive identification rate and 99.9% correct rejection rate was achieved.
Materials tested *
Handheld Raman spectroscopy offers an attractive alternative to other analytical techniques for identity verification of raw
materials. The technology's specificity for a wide range of materials, its ease of method development and validation, and
the ability to directly transfer methods between instruments, enable handheld Raman spectroscopy to both improve the quality
of raw-materials testing while reducing cost.
Table I: Instrument specifications.
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1. T. Vankeirsbilck et al., "Applications of Raman Spectroscopy in Pharmaceutical Analysis," TrAC
21 (12), 869–877, (2002).
2. R.L. McCreery et al., "Noninvasive Identification of Materials Inside USP Vials with Raman Spectroscopy and a Raman Spectral
Library," J. Pharm. Sci.
87 (1), 1–8 (1998).
3. R. Cantu et al., "A Simple Approach for Developing, Validating, and Transferring an Identification Method for Multidose
Pharmaceutical Products using FT-Raman Spectroscopy," Am. Pharm. Review
10 (2), 96–103, 111 (2007).
4. R.L. Green and C.D. Brown, "Raw-Material Authentication Using a Handheld Raman Spectrometer," Pharm. Technol.
32 (3), 148–163 (2008).
5. USP 32–NF 27 ‹1120› "Raman spectrometry," p. 1120.
6. ICH Q2R1 Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodolgy (Geneva, Switzerland, 2005).
7. S.R. Lowry, "Automated Spectral Searching in Infrared, Raman, and Near-Infrared Spectroscopy," in Handbook of Vibrational Spectroscopy, Vol.3 (Wiley, New York, 2001), pp. 1948-1961.
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Robert L. Green* is a research scientist, Robert Brush is an application scientist, Wayne Jalenak is a senior application
scientist, and Christopher D. Brown is director of system analytics and applications, all at Ahura Scientific, 46 Jonspin
Rd., Wilmington, MA 01887, tel. 978.657.5555, fax 978.657.5921, firstname.lastname@example.org
*To whom all correspondence should be addressed.
Submitted: Jan. 6, 2009. Accepted: Feb. 3, 2009.