Validation of Raman spectroscopic procedures in agreement with ICH guideline Q2 with considering the transfer to real time monitoring of an active coating process.
A multivariate model was constructed by correlating Raman spectral data with coated amount of the API diprophylline using Partial Least Squares. In agreement with ICH guideline Q2 the method was validated in order to achieve the requirement of demonstrating that Raman spectroscopy is suitable as rapid PAT tool for inline quantitative monitoring of active coating. The present work presents an appropriate approach to transfer the requirements of the guidelines to the Raman method used for inline measurements and demonstrates that the requirements of the validation characteristics were achieved.
Müller
Joshua
J
Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Universitaetsstrasse 1, Düsseldorf, Germany.
Knop
Klaus
K
Wirges
Markus
M
Kleinebudde
Peter
P
D004400:Dyphylline / Q000032:analysis; D017408:Guidelines as Topic; D016018:Least-Squares Analysis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013059:Spectrum Analysis, Raman / Q000379:methods*; D013607:Tablets / Q000032:analysis*; D013678:Technology, Pharmaceutical; D013997:Time Factors
D013607:Tablets; D004400:Dyphylline