Using NIR spectroscopy as an integrated PAT tool

Spectroscopy (Santa Monica)

Volumn 19, Issue 12, 2004, Pages 104-109

  Cogdill, Robert P ^a   Anderson, Carl A ^a   Drennen III, James K ^a  

^a DUQUESNE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACOUSTO-OPTIC TUNABLE FILTER (AOTF); NEAR-INFRARED (NIR) SPECTROSCOPY; PRECALIBRATION; PROCESS ANALYTICAL TECHNOLOGY (PAT);

AUTOMATION; CALIBRATION; DRUG PRODUCTS; DRUG PRODUCTS PLANTS; LIGHT REFLECTION; PROCESS ENGINEERING; SPECTROMETERS;

INFRARED SPECTROSCOPY;

EID: 23344436294     PISSN: 08876703     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (11)

1. FDA, Draft Guidance for industry, "PAT-A Framework for Innovative Manufacturing and Quality Assurance, Draft Guidance," (FDA, Rockville, MD, 2003).
2. P. Williams and K. Norris, Eds., Near-Infrared Technology In the Agricultural and Food Industries (American Association of Cereal Scientists, St. Paul, MN, 2d ed., 2001), p. 296.
3. R.P. Cogdill et al., "Process Analytical Technology Case Study, Part II: Development and Validation of Quantitative for Tablet API Content and Hardness," AAPS Pharm SciTech, submitted for publication.
4. R.P. Cogdill et al., "Process Analytical Technology Case Study, Part I: Feasibility Studies for Quantitative NIR Method Development," AAPS Pharm ScTech, submitted for publication.
5. R.P. Cogdill, C.A. Anderson, and J.K. Drennen, "Process Analytical Technology Case Study, Part III: Calibration Monitoring and Transfer," AAPS Pharm-SciTech, submitted for publication.
6. General Chapter (1119), "Near-Infrared Spectrophotometry," USP 27-NF 22, 2d Suppl. (US Pharmacopeial Convention, Rockville, MD, 2004), pp. 3337-3344.
7. H. Martens and T. Nass, Multivariate Calibration (John Wiley and Sons, New York, NY, 1989).
8. AACC, "Near-Infrared Methods: Guidelines for Model Development and Maintenance, AACC Method 39-00," in Approved Methods of the American Association of Cereal Chemists (AACC Press, St. Paul, MN, 1999).
9. J.D. Kirsch and J.K. Drennen, "Nonde-structive Tablet Hardness Testing by Near-Infrared Spectroscopy: A New and Robust Spectral Best-Fit Algorithm," J. Pharm. Biomed. Anal. 19 (3-4), pp. 351-362 (1999).
10. International Conference on Harmonization, International Conference on Harmonization Quality Guidlines: Analytical Validation Guidlines Q2A & Q2B (ICH, Geneva, Switzerland, 2004).
11. General Chapter (1225), "Validation of Compendial Methods," USP 27-NF 22 (US Pharmacopeial Convention, Rockville, MD, 2003), pp. 2622-2625.