title: Determination of moisture content of lyophilized allergen vaccines by NIR spectroscopy.
abstract: Moisture content is an important parameter for lyophilized vaccines. Currently, Karl Fischer titration is widely used for moisture determination in routine analysis. However, this method is time-consuming, sample destructive and requires environment polluting reagents, as well as the results rely on the random samplings. In this study, near infrared spectroscopy was used as a fast, non-invasive and non-destructive method to determine the moisture content in lyophilized allergy vaccines. Five different vaccine products were investigated, which contained water in the range of 0.17-1.51% (w/w, KF). Different data pre-treatments, wavelength selection and partial least squares regression were applied to construct calibration models. Multi-products model and product-specific models were obtained, which show the possibility of NIR as a rapid method to discriminate whether moisture content fit into the specifications of a pharmaceutical company.
authors.affiliation: ALK-ABELLO A/S, Hørsholm, Denmark.
authors.forename: Yiwu
authors.initials: Y
authors.lastname: Zheng
authors.forename: Xuxin
authors.initials: X
authors.lastname: Lai
authors.forename: Susanne Wrang
authors.initials: SW
authors.lastname: Bruun
authors.forename: Henrik
authors.initials: H
authors.lastname: Ipsen
authors.forename: Jørgen Nedergaard
authors.initials: JN
authors.lastname: Larsen
authors.forename: Henning
authors.initials: H
authors.lastname: Løwenstein
authors.forename: Ib
authors.initials: I
authors.lastname: Søndergaard
authors.forename: Susanne
authors.initials: S
authors.lastname: Jacobsen
mesh_terms: D000485:Allergens / Q000032:analysis*; D002138:Calibration; D005612:Freeze Drying; D016018:Least-Squares Analysis; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D014612:Vaccines / Q000032:analysis*; D014867:Water / Q000032:analysis*
chemical_list: D000485:Allergens; D014612:Vaccines; D014867:Water