TY - JOUR
T1 - Determination of moisture content of lyophilized allergen vaccines by NIR spectroscopy
AU - Zheng, Yiwu
AU - Lai, Xuxin
AU - Bruun, Susanne Wrang
AU - Ipsen, Henrik
AU - Larsen, Jørgen Nedergaard
AU - Løwenstein, Henning
AU - Søndergaard, Ib
AU - Jacobsen, Susanne
PY - 2008
Y1 - 2008
N2 - 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. (c) 2007 Elsevier B.V. All rights reserved.
AB - 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. (c) 2007 Elsevier B.V. All rights reserved.
U2 - 10.1016/j.jpba.2007.11.011
DO - 10.1016/j.jpba.2007.11.011
M3 - Journal article
C2 - 18162356
SN - 0731-7085
VL - 46
SP - 592
EP - 596
JO - Journal of Pharmaceutical and Biomedical Analysis
JF - Journal of Pharmaceutical and Biomedical Analysis
IS - 3
ER -
