title: Comparison of near infrared and microwave resonance sensors for at-line moisture determination in powders and tablets.
abstract: In this paper we demonstrate the feasibility of replacing KF for water content testing in bulk powders and tablets with at-line near infrared (NIR) or microwave resonance (MR) methods. Accurate NIR and MR prediction models were developed with a minimalistic approach to calibration. The NIR method can accurately predict water content in bulk powders in the range of 0.5-5% w/w. Results from this method were compared to a MR method. We demonstrated excellent agreement of both NIR and MR methods for powders vs. the reference KF method. These methods are applicable to in-process control or quality control environments. One of the aims of this study was to determine if a calibration developed for a particular product could be used to predict the water content of another product (with related composition) but containing a different active pharmaceutical ingredient (API). We demonstrated that, contrary to the NIR method, a general MR method can be used to predict water content in two different types of blends. Finally, we demonstrated that a MR method can be developed for at-line moisture determination in tablets.
authors.affiliation: Analytical and Bioanalytical Development, Bristol-Myers Squibb, New Brunswick, NJ 08901, United States. claudia.corredor@bms.com
authors.forename: Claudia C
authors.initials: CC
authors.lastname: Corredor
authors.forename: Dongsheng
authors.initials: D
authors.lastname: Bu
authors.forename: Douglas
authors.initials: D
authors.lastname: Both
mesh_terms: D004867:Equipment Design; D006813:Humidity; D008872:Microwaves; D011208:Powders / Q000737:chemistry*; D012680:Sensitivity and Specificity; D019265:Spectroscopy, Near-Infrared / Q000295:instrumentation / Q000379:methods*; D013607:Tablets / Q000737:chemistry*; D014867:Water / Q000032:analysis*
chemical_list: D011208:Powders; D013607:Tablets; D014867:Water