Frequency Modulation Spectroscopy - Pharmaceutical Technology

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Frequency Modulation Spectroscopy
A Novel Nondestructive Approach for Measuring Moisture Activity in Pharmaceutical Samples


Pharmaceutical Technology


The authors thank Jim Veale and Bobby Anderson of Lighthouse Instruments, Inc., as well as the vendors of the other two instruments whose cooperation has greatly facilitated the work described in this report. The authors also thank Joshua Stull, Ngocyen Le, Elijah Tan, John Shust, Christopher Gilman, Brad Holstine, Brandon McWilliams, Jimmy George, Sean Hutchinson, and William Lewis for their help in the collection and compilation of these data.

Note

The information described in this report does not constitute endorsement of any particular instrument type or supplier by Merck & Co., Inc.

Rajiv Mahajan,* is a research fellow
Allen C. Templeton is research fellow, Robert A. Reed is a senior director, and Rey T. Chern is a senior research fellow, all at Pharmaceutical Research & Development, Merck Research Laboratories, Merck & Co., Inc., West Point, PA 19486.

*To whom all correspondence should be addressed.

Submitted: Dec. 16, 2004. Accepted: Feb. 9, 2005.

References

1. R.R. Friedel, "The Application of Water Measurement to Microbiological Attributes Testing of Raw Materials Used in the Manufacture of Nonsterile Pharmaceutical Products," Pharm. Forum 25 (5), 8974–8981 (1999).

2. R.R. Friedel, "The Application of Water Measurement to Microbiological Attributes Testing of Nonsterile Over the Counter Drug Products," Pharm. Forum 24 (2), 6087–6090 (1998).

3. S.H. Lee and T.P. Labuza, "Destruction of Ascorbic Acid as a Function of Water Activity," J. Food Sci. 40 , 370–373 (1975).

4. M. Loncin, J.J. Bimbenet, and J. Lenges, "Influence of the Activity of Water on the Spoilage of Foodstuffs," J. Food Technol. 3, 131–142 (1968).

5. B.G. Kyle, "Principles of Phase Equilibrium" in Chemical and Process Thermodynamics (Prentice Hall, Upper Saddle River, NJ, 1984).

6. M.J. Kontny and G. Zografi, "Sorption of Water in Solids" in Physical Characterization of Pharmaceutical Solids, H.G. Brittain, Ed. (Marcel Dekker, New York, NY, 1995).

7. H. Xu et al.,"Rapid, Simultaneous Determination of Headspace Oxygen and Moisture in Pharmaceutical Packages using muGC," J. Pharm. Biomed. Anal. 38 (2), 225–231 (2005).

8. A.C. Templeton et al., "Rapid Headspace Oxygen Analysis for Pharmaceutical Packaging Applications," Pharm. Technol. 26 (7), 41–61 (2002).

9. A.C. Templeton et al., "Determination of the Moisture Content of Bromobutyl Rubber Stoppers as a Function of Processing: Implications Toward the Stability of Lyophilized Products," PDA J. Pharm. Sci. Technol. 57 (2), 75–87 (2003).

10. J.N. Demas, B.A. DeGraff, and P.B. Coleman, "Oxygen Sensors based on Luminescence Quenching," Anal. Chem. 71 (23), 793–801 (1999).


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