4.6 Article

Simultaneous analysis of moisture, active component and cake structure of lyophilized powder for injection with diffuse reflectance FT-NIR chemometrics

Journal

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Volume 55, Issue 1, Pages 216-219

Publisher

ELSEVIER SCIENCE BV
DOI: 10.1016/j.jpba.2010.12.028

Keywords

Fourier transform near infrared spectroscopy; Moisture; Active component; Cake structure; Lyophilized powder for injection

Funding

  1. Chongqing Yaoyou Pharmaceutical Co., Ltd.
  2. Thermo Fisher Scientific Co., Ltd.

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This paper establishes a novel method for the simultaneous analysis of moisture, active component and cake structure of lyophilized powder for injection using diffuse reflectance Fourier transform near infrared (FT-NIR) chemometrics. The experiment indicated that the back-propagation artificial neural network (BP-ANN) was suitable for the content predictions of moisture and active component; the root mean square errors of prediction (RMSEPs) were 0.1471 and 0.0082, the correlation coefficients (Rs) of prediction 0.9553 and 0.9891. And the self-organizing map (SOM) was adapted to the discrimination of cake structures; the prediction accuracy was 100.0%. (C) 2010 Elsevier B.V. All rights reserved.

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