About FDA

Division of Pharmaceutical Analysis Recent Publications

645 S. Newstead Avenue
St. Louis, Missouri 63101
Phone: (314) 539-2135 Fax: (314) 539-2113

Lucinda Buhse, Ph.D., Director
John Kauffman, Ph.D., Deputy Director

Journal Articles


Adams, W., Amann, A, Bertha, C., Byron, P.R., Christopher, D., Doub, W., Dunbar, C., Hauck, W., Lyapustina, S., Mitchell, J., Morgan, B., Nichols, S., Pan, Z., Singh, G.J.P., Tougas, T., Tsong, Y., Wolff, R., Wyka, B.  Evaluation of cascade impactor profiles of pharmaceutical aerosols: (Final PQRI Report) Part 1- Background for a statistical method. Part 2- Evaluation of a method for determining equivalence. AAPS PharmSciTech 8(1): 4 (2007). For Part 2_ AAPS PharmSciTech 8(1):5 (2007)

Christopher,  D. Members of the working group (in alphabetical order) are: Adams, W., Amann, A., Bertha, C., Byron, P., Doub, W., Dunbar, C., Hauck, W.,  Lee, D., Lostritto, R., Lyapustina, S., Mitchell, J., Morgan, B., Nichols, S., Pan, Z., Jai, G., Singh, P., Tougas, T., Tsong, Y., Wolff, R., Wyka, B. and the Working Group’s liaisons to the PQRI Drug Product Technical Committee: Golden, M. and  Poochikian, G.  PQRI evaluation of cascade impactor profiles of pharmaceutical aerosols: Part 3 – Final report on a statistical procedure for determining equivalence.  AAPS PharmSciTech. 8(4):90 (2007)

Doub, W., Adams, W., Spencer, J., Buhse, L. Nelson, M., Treado, P.  Raman chemical imaging for ingredient-specific particle size characterization of aqueous suspension nasal spray formulations: A Progress Report. Pharmaceutical Research 24(5):934-945 (2007)

Gao, Z., Moore, T. and Doub, W.  The vibration effect on dissolution tests with USP Apparatus 1&2.  Journal of Pharmaceutical Science, Online (2007)

Gao, Z., Moore, T., Smith, A., Doub, W. and Westenberger, B.  Studies of variability in dissolution testing with USP Apparatus 2Journal of Pharmaceutical Sciences 96 (17):1794-1801 (2007)

Gao, Z., Moore, T., Smith, A., Doub, W., Westenberger, B. and Buhse, L.  Gauge repeatability and reproducibility (Gauge R&R) for accessing variability during dissolution testing.  AAPS PharmSciTech. 8(4):Article 82 (2007)

Gryniewicz, C. M., Spencer, J. A., Hankins, M. and Kauffman, J.  Spectroscopic methods for rapid determination of diethylene glycol in glycerin. American Pharmaceutical Review 10 (7):24-30 (2007)

Guo, C., Gillespie, S. and Doub, W.  Comparison of delivery characteristics from a combination metered-dose inhaler using the Andersen Pharmaceutical Impactor and the Next Generation Cascade Impactor.  Journal of Pharmaceutical Sciences, Online (2007) 

Kakhi, M., Prodduturi, S., Wokovich, A., Doub, W., Buhse, L., Sadrieh. N., Risk analysis of transdermal drug delivery systems.  Pharmaceutical Engineering 27(6):1-11 (2007)

Kauffman, J., Dellibovi, M., Cunningham, C.R. Raman spectroscopy of coated pharmaceutical tablets and physical models for multivariate calibration to tablet coating thickness.  J. Pharm. Biomed. Anal. 43(1):39-48 (2007)

Kauffman, J., Tumuluri, V., Guo, C., Spencer, J., Doub, W., Nichols, G., Randle, S., Wu, S.  Near infrared spectroscopy of magnesium stearate hydrates and multivariate calibration of pseudopolymorph composition.  Journal of Pharmaceutical Sciences, Online (June, 2007)

Kauffman, J., Westenberger, B., Jacobs, A., Cummins, S., Guthrie, J. and Robertson, J.  Lead in pharmaceutical products and dietary supplements. Regulatory Toxicology and Pharmacology 48(2):128-134 (2007)

Reepmeyer, J. and Woodruff, J. Use of liquid chromatography-mass spectrometry and a chemical cleavage reaction for the structure elucidation of a new slideafil analogue detected as an adulterant in an herbal dietary supplement.  Journal of Pharmaceutical and Biomedical Analysis 44(4):887-893 (2007)

Reepmeyer, J., Woodruff, J. and d’Avignon, D.  Structure elucidation of a novel analogue of sildenafil detected as an adulterant in an herbal dietary supplement.  Journal of Pharm and Biomed Analysis 43(5):1615-1621 (2007)

Spencer, J., Gao, Z., Moore, T., Buhse, L., Newnham, D., Shen, Y., Portieri, A.,   Hussian, A.  Delayed release tablet dissolution related to coating thickness by terahertz pulsed image mapping.  Journal of Pharmaceutical Sciences, Online (2007)

Snorek, S., Bauer, J., Chidambaram, N., Doub, W., Duffy, E., Etzler, F., Kelly, R., Lane, J., Mueller, R., Prasanna, H., Pujara, C., Reif, V., Scarlett, B., Stowell, J., Toma, P.  PQRI recommendations on particle-size analysis of drug substances used in oral dosage forms.  Journal of Pharmaceutical  96(6):1451-1467 (2007)


Gao, Z., Moore, T., Doub, W., Westenberger, B. and Buhse, L.  Effects of deaeration methods on dissolution testing in aqueous media: A study using a total dissolved gas pressure meter.   Journal of Pharmaceutical Science, 95, 1606-1613 (2006)

Guo, C. and Doub, W. Development of a novel technology to measure impaction force of nasal sprays and metered dose inhalers using the texture analyzer.   Respiratory Drug Delivery 2:621-624 (2006)

Guo, C. and Doub, W.  Use of Raman imaging for determination of the particle size distribution (PSD) of active pharmaceutical ingredients (APIs) in metered dose inhalers.   Respiratory Drug Delivery 2:617-620 (2006)

Guo, Changning and Doub, W.  The influence of actuation parameters on in-vitro testing of nasal spray products.  J. Pharm Sci. 95(9):2029-2040 (2006)

Reepmeyer, J. and Woodruff, J.  Use of liquid chromatography-mass spectrometry and a hydrolytic technique for the detection and structure elucidation of a novel synthetic vardenafil designer drug added illegally to a “natural” herbal dietary supplement.  J. Chromatogr. A 1125:67-75 (2006)

Wokovich, A., Prodduturi, S., Doub, W., Hussain, A. and Buhse, L. Transdermal drug delivery system (TDDS) adhesion as a critical safety, efficacy, and quality attribute.  Eur. J. Pharmaceutics Biopharmaceutics 64(1):1-8 (200

Ye, H.  Simultaneous determination of protein aggregation and stability as well as absolute molecular weight by SEC-MALLS.  Analytical Biochemistry 356(1):76-85 (2006)


Buhse, L., Kolinski, R., Westenberger, B., Wokovich, A., Spencer, J., Chen, C., Turujman, S., Gautam-Basak, M., Kang, G., Kibbe, A., Heintzelman, B., and Wolfgang. Topical drug classification E.  Int J Pharm, 295(1-2):101-112 (2005)

Reepmeyer, J. Analysis of the nitrogen mustard mechlorethamine in topical pharmaceutical preparations by high performance liquid chromatography.   J.Chromatogr. A 1085(2):262-269 (2005)

Reepmeyer, J., Brower, J., and Ye, H.  Separation and detection of the isomeric equine conjugated estrogens, equilin sulfate and ∆8,9-dehydroestrone sulfate, by liquid chromatography-electrospray-mass spectrometry. Chromatogr. A 1083:42-51 (2005)

Sadrieh, N., Brower, J., Yu, L., Doub, W., Straughn, A., Machado, S., Pelsor, F., Saint Martin, E., Moore, T., Reepmeyer, J., Toler, D., Nguyenpho, A., Roberts, R., Schuirmann, D., Nasr, M. and Buhse, L.  Stability, dose uniformity and palatability of three counterterrorism drugs - human subject and electronic tongue studies.  Pharm. Res. 22(10):1747-1756 (2005)

Westenberger, B., Ellison, C., Fussner, A., Jenney, S., Kolinski, R., Lipe, T., Lyon, R., Moore, T., Revelle, L., Smith, A., Spencer, J.,  Story, K., Toler, D., Wokovich, A., and Buhse, L. Quality assessment of internet pharmaceutical products using traditional and novel analytical techniques.  L. Int J Pharm. 306(1-2):56-70 (2005)

Wokovich, A., Spencer, J., Westenberger, B., Buhse, L., and Jasper, J.  Stable isotopic composition of the active pharmaceutical ingredient (API) naproxen. J Pharm Biomed Anal, 38(4):781-784 (2005)

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