Near-infrared analysis

There is intense interest in using NIR techniques in several major areas of pharmaceutical operations clinical supply identification, incoming raw material 

FIGURE 14 Raman spectra of three ibuprofen formulations. Ibuprofen formulations solution (dimer 3), solid line extrudate (PVP), dashed line crystalline powder, dotted line. The ibuprofen extrudate and solution are shifted compared to the crystalline form of ibuprofen. (Reprinted with permission from ref. 25, Copyright 1999, Plenum.) 

The following sections describe qualitative and quantitative examples of validated NIR methods currently in use. 

NIR analysis is particularly suited to the verification of the identity of packaged clinical supplies because of its nondestructive nature, speed, and low cost. Because every clinical study is a unique event consisting of a finite population of dosage forms, models can easily be generated and validated, and the final-blinded products can be tested the same day that the analysis request is made. 

An NIR spectroscopic method to identify pharmaceutically active and inactive (placebo) clinical dosage forms was recently developed.Typically, the dosage form is packaged with its placebo in the same blister pack. The purpose of the NIR identification method was to identify, nondestructively and rapidly, the four forms in the blister pack. The method was developed to create and validate a one-time-use library of the spectra of clinical dosage forms prepared for double-blind clinical trials. 

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D. A. Bums and E. W. Ciurczak, eds.. Handbook of Near-Infrared Analysis, Marcel Dekker, Inc., New York, 1992. 

R. DiFoggio, Examination of some misconceptions abont near-infrared analysis, Appl. Spectrosc., 49, Cl (1995). 

B. Buchanan and D. Honigs, Trends in near-infrared analysis. Trends Anal. Chem., 5, 154—157 (1986). 

Burns DA, Ciurczak EW. Handbook of Near-Infrared Analysis Practical Spectroscopy. 2nd ed. New York Marcel Dekker, 1992. 

Bums, D. A. and Ciurczak, E. W. (2001). Hand Book of Near-Infrared Analysis. Taylor Francis, New York, p. 814. 

Olinger, J.M., Griffiths, P.R. and Burger, T. (2001) Theory of diffuse reflectance in the NIR region. In Bums, D. and Ciurczak, E.W. (eds) Handbook of Near-Infrared Analysis, 2nd Edition Marcel Dekker New York, pp. 19-52. 

Burns, Donald A. Ciurczak, Emil W. (eds) Handbook of Near-Infrared Analysis, 2nd Edition Marcel Dekker NY, 2001. 

Burns DA, Ciurcziak EW (1992) Handbook of near infrared analysis. Decker, New York... 

One of the advantages of the FTIR spectrometer is the facility of sample preparation procedure. It is possible to press powder into pellet. In this method, different diluents (matrixes) can be selected for several applications. For mid-IR frequency range, KBr, KC1, or diamond dust can be used. For far-infrared testing, high-density polyethylene (HDPE) or diamond dust is suitable. For near-infrared analysis, Csl or KBr can be selected or mulls may be used as alternatives to pellets. The sample... 

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