Development and transferability of near-infrared methods for determination of moisture in a freeze-dried injection product

摘要: Abstract Near-infrared reflectance (NIR) methods for non-invasive and non-destructive measurement of moisture in a lyophilized product were developed independently at two sites. NIR spectra collected with the same model instrument each site. The scanned through bases unopened glass vials using horizontal accessory. primary reference data content generated Karl—Fischer titration on individual vials. calibration equations second derivative spectral regression programs within software. These validated independent test from additional original site, cross tested against similar other site to check their robustness. This comparison demonstrated that equation one could satisfactorily be used predicting contents manufactured Expected variations arising differences vial material, manufacturing process, analysts instruments appeared accommodated. Finally, sets obtained by scanning set samples spectrometers results these comparable solely instruments. all are presented discussed, an assessment method transferability between sites is given.