Selection of analytical techniques for pharmaceutical leachables studies

American Pharmaceutical Review

Volumn 8, Issue 6, 2005, Pages 38-44

  Wang, Qingxi ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ATOMIC ABSORPTION SPECTROMETRY; CHEMOLUMINESCENCE; DRUG DOSAGE FORM; DRUG INDUSTRY; DRUG SELECTIVITY; ELECTROCHEMICAL DETECTION; FLUORESCENCE; GAS CHROMATOGRAPHY; INFRARED SPECTROMETRY; LEACHING; MASS SPECTROMETRY; REFRACTION INDEX; REVIEW; THERMAL CONDUCTIVITY; ULTRAVIOLET SPECTROPHOTOMETRY;

EID: 33745677765     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (6)

1. Norwood, D.L.; Nagao, L.; Lyapustina, S.; Munos, M. Application of Modern Analytical Technologies to the Identification of Extractables and Leachables. Am. Pharm. Rev. 2005, 8 (1), 78-87.
2. Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products; Draft Guidance for Industry; U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CEDER): Rockville, MD, October 1998; 1-62.
3. Jenke, D.R.; Nomenclature Associated with Chemical Characterization of and Compatibility Evaluations of Medical Product Delivery Systems. J. Pharm. Sci. Technol. 2003, 57 (2), 97-108.
4. Norwood, D.L.; Mullis, J.O. Extractables and Leachables Encyclopedia of Pharmaceutical Technology, Marcel Dekker: New York, in press, 2005.
5. Zweifel, H. Plastics Additives Handbook 5th ed. Hanser Gerdner Publications, 2001.
6. Skoog, D.A. Principles of Instrumental Analysis, 3rd ed. Saunders College Publishing, 1985.