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  • Title: Determination of moisture content of lyophilized allergen vaccines by NIR spectroscopy.
    Author: Zheng Y, Lai X, Bruun SW, Ipsen H, Larsen JN, Løwenstein H, Søndergaard I, Jacobsen S.
    Journal: J Pharm Biomed Anal; 2008 Feb 13; 46(3):592-6. PubMed ID: 18162356.
    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.
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