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Research ArticleResearch

How pH, Temperature, and Time of Incubation Affect False-Positive Responses and Uncertainty of the LAL Gel-Clot Test

Felipe Rebello Lourenço, Túlia De Souza Botelho and Terezinha De Jesus Andreoli Pinto
PDA Journal of Pharmaceutical Science and Technology November 2012, 66 (6) 542-546; DOI: https://doi.org/10.5731/pdajpst.2012.00887
Felipe Rebello Lourenço
Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, Brazil
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  • For correspondence: feliperl@usp.br
Túlia De Souza Botelho
Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, Brazil
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Terezinha De Jesus Andreoli Pinto
Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, Brazil
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References

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    1. Jiménez L
    1. Williams K. L
    . Chapter 8. Endotoxin: Relevance and Control in Parenteral Manufacturing. In Microbial Contamination Control in the Pharmaceutical Industry; Jiménez L ., Ed.; Marcel Dekker: New York, 2004; pp 183–249.
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    1. Pinto T. J. A.,
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    . Chapter 9. Pirogênio e Endotoxina Bacteriana. In Controle Biológico de Qualidade de Produtos Farmacêuticos, Correlatos e Cosméticos; Pinto T. J. A., Kaneko T. M., Pinto A. F ., Eds.; Atheneu Editora: São Paulo, Brazil, 2010; pp 495–546.
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    United States Pharmacopeia, 35th ed.; United States Pharmacopeia Convention: Rockville, MD, 2012; p 88–92.
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    1. Prince R
    1. Cooper J. F
    . Chapter 22. Bacterial Endotoxins Test. In Microbiology in Pharmaceuticals Manufacturing, 2nd ed.; Prince R ., Ed.; DHI: Bethesda, MD, 2008; pp 245–274.
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    1. Pearson F. C
    . Pyrogens: Endotoxins, LAL Testing and Depyrogenation. Marcel Dekker: New York, 1985; p 272.
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    1. Lourenço F. R.,
    2. Kaneko T. M.,
    3. Pinto T. J. A
    . Estimativa da incerteza em ensaio de detecção de endotoxina bacteriana pelo método de gelificação. Braz. J. Pharm. Sci. 2005, 41 (4), 438–443.
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    . Quantifying uncertainty in qualitative analysis. Analyst 1998, 123 (5), 1155–1161.
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    1. Ellison S. L. R
    . Uncertainties in qualitative testing and analysis. Accred. Qual. Assur. 2000, 5 (8), 346–348.
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    Farmacopeia Brasileira, 5th ed. Brasília: Agência Nacional de Vigilância Sanitária: Brasília, Brazi, 2010; pp 230–234.
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    . Chapter 3. As Tabelas 2 × 2. In Bioestatística: Tópicos Avançados, Vieira S ., Ed.; Elsevier: Rio de Janeiro, Brazil, 2004; p 216.
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    1. Cooper J. F
    . Resolving LAL test interferences. PDA J. Pharm. Sci. Technol. 1990, 44 (1), 13–15.
    OpenUrlAbstract/FREE Full Text
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PDA Journal of Pharmaceutical Science and Technology: 66 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 6
November/December 2012
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How pH, Temperature, and Time of Incubation Affect False-Positive Responses and Uncertainty of the LAL Gel-Clot Test
Felipe Rebello Lourenço, Túlia De Souza Botelho, Terezinha De Jesus Andreoli Pinto
PDA Journal of Pharmaceutical Science and Technology Nov 2012, 66 (6) 542-546; DOI: 10.5731/pdajpst.2012.00887

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How pH, Temperature, and Time of Incubation Affect False-Positive Responses and Uncertainty of the LAL Gel-Clot Test
Felipe Rebello Lourenço, Túlia De Souza Botelho, Terezinha De Jesus Andreoli Pinto
PDA Journal of Pharmaceutical Science and Technology Nov 2012, 66 (6) 542-546; DOI: 10.5731/pdajpst.2012.00887
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Keywords

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  • LAL test
  • Uncertainty

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