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Rapid identification of microbial contaminants in pharmaceutical products using a PCA/LDA-based FTIR-ATR method
Brito, Natália Monte Rubio de; Lourenço, Felipe Rebello.
  • Brito, Natália Monte Rubio de; Universidade de São Paulo. Faculdade de Ciências Farmacêuticas. Departamento de Farmácia. São Paulo. BR
  • Lourenço, Felipe Rebello; Universidade de São Paulo. Faculdade de Ciências Farmacêuticas. Departamento de Farmácia. São Paulo. BR
Braz. J. Pharm. Sci. (Online) ; 57: e18899, 2021. tab, graf
Article in English | LILACS | ID: biblio-1339302
ABSTRACT
Microbiological quality of pharmaceuticals is fundamental in ensuring efficacy and safety of medicines. Conventional methods for microbial identification in non-sterile drugs are widely used; however they can be time-consuming and laborious. The aim of this paper was to develop a chemometric-based rapid microbiological method (RMM) for identifying contaminants in pharmaceutical products using Fourier transform infrared with attenuated total reflectance spectrometry (FTIR-ATR). Principal components analysis (PCA) and linear discriminant analysis (LDA) were used to obtain a predictive model capable of distinguishing Bacillus subtilis (ATCC 6633), Candida albicans (ATCC 10231), Enterococcus faecium (ATCC 8459), Escherichia coli (ATCC 8739), Micrococcus luteus (ATCC 10240), Pseudomonas aeruginosa (ATCC 9027), Salmonella typhimurium (ATCC 14028), Staphylococcus aureus (ATCC 6538), and Staphylococcus epidermidis (ATCC 12228) microbial growth. FTIR-ATR spectra provide data on proteins, DNA/RNA, lipids, and carbohydrates constitution of microbial growth. Microbial identification provided by PCA/LDA based on FTIR-ATR method were compatible with those obtained using traditional microbiological methods. The chemometric-based FTIR-ATR method for rapid identification of microbial contaminants in pharmaceutical products was validated by assessing the sensitivity (93.5%), specificity (83.3%), and limit of detection (17-23 CFU/mL of sample). Therefore, we propose that FTIR-ATR spectroscopy may be used for rapid identification of microbial contaminants in pharmaceutical products and taking into account the samples studied
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Full text: Available Index: LILACS (Americas) Main subject: Spectrum Analysis / Pharmaceutical Preparations / Discriminant Analysis / Spectroscopy, Fourier Transform Infrared / Fourier Analysis Type of study: Diagnostic study / Prognostic study Language: English Journal: Braz. J. Pharm. Sci. (Online) Journal subject: Farmacologia / Terapˆutica / Toxicologia Year: 2021 Type: Article Affiliation country: Brazil Institution/Affiliation country: Universidade de São Paulo/BR

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Full text: Available Index: LILACS (Americas) Main subject: Spectrum Analysis / Pharmaceutical Preparations / Discriminant Analysis / Spectroscopy, Fourier Transform Infrared / Fourier Analysis Type of study: Diagnostic study / Prognostic study Language: English Journal: Braz. J. Pharm. Sci. (Online) Journal subject: Farmacologia / Terapˆutica / Toxicologia Year: 2021 Type: Article Affiliation country: Brazil Institution/Affiliation country: Universidade de São Paulo/BR