Verification Methods for 198 Common Raw Materials Using a Handheld Raman Spectrometer - Pharmaceutical Technology

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Verification Methods for 198 Common Raw Materials Using a Handheld Raman Spectrometer
Using handheld Raman spectroscopy, methods were developed and evaluated for 198 substances widely used as raw materials.


Pharmaceutical Technology
Volume 33, Issue 10, pp. 72-82

Conclusion


Materials tested *
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.


Table I: Instrument specifications.
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.




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References

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,

*To whom all correspondence should be addressed.

Submitted: Jan. 6, 2009. Accepted: Feb. 3, 2009.


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