Performance Equivalence and Validation of a Rapid Microbiological Method for Detection and Quantification of Yeast and Mold in an Antacid Oral Suspension

Harold A. Prada-Ramírez; Ángela Aurora BeltrÁn-Osuna; Sandra Celeita; Juan Camilo Fonseca

doi:10.5731/pdajpst.2021.012632

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Performance Equivalence and Validation of a Rapid Microbiological Method for Detection and Quantification of Yeast and Mold in an Antacid Oral Suspension

Harold A. Prada-Ramírez, Ángela Aurora BeltrÁn-Osuna, Sandra Celeita and Juan Camilo Fonseca

PDA Journal of Pharmaceutical Science and Technology July 2023, 77 (4) 268-280; DOI: https://doi.org/10.5731/pdajpst.2021.012632

Harold A. Prada-Ramírez

1Laboratorios Coaspharma S.A.S., CL 18A 28A-43, Bogotá, Colombia; and

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Ángela Aurora BeltrÁn-Osuna

2Escuela Tecnológica Instituto Técnico Central La Salle, CL 13 16-74, Bogotá, Colombia

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Sandra Celeita

1Laboratorios Coaspharma S.A.S., CL 18A 28A-43, Bogotá, Colombia; and

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Juan Camilo Fonseca

1Laboratorios Coaspharma S.A.S., CL 18A 28A-43, Bogotá, Colombia; and

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For correspondence: camilo.fonseca@coaspharma.co

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vol. 77 no. 4 268-280

DOI

https://doi.org/10.5731/pdajpst.2021.012632

PubMed

37085183

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online August 11, 2023.

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previous version (April 21, 2023 - 05:02).
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Harold A. Prada-Ramírez¹,
Ángela Aurora BeltrÁn-Osuna²,
Sandra Celeita¹ and
Juan Camilo Fonseca¹,*

¹Laboratorios Coaspharma S.A.S., CL 18A 28A-43, Bogotá, Colombia; and
²Escuela Tecnológica Instituto Técnico Central La Salle, CL 13 16-74, Bogotá, Colombia

↵*Corresponding Author: Laboratorios Coaspharma S.A.S., Bogotá D.C., Colombia; Telephone: +57 318 5990782; E-mail: camilo.fonseca{at}coaspharma.co

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Performance Equivalence and Validation of a Rapid Microbiological Method for Detection and Quantification of Yeast and Mold in an Antacid Oral Suspension

Harold A. Prada-Ramírez, Ángela Aurora BeltrÁn-Osuna, Sandra Celeita, Juan Camilo Fonseca

PDA Journal of Pharmaceutical Science and Technology Jul 2023, 77 (4) 268-280; DOI: 10.5731/pdajpst.2021.012632

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Performance Equivalence and Validation of a Rapid Microbiological Method for Detection and Quantification of Yeast and Mold in an Antacid Oral Suspension

Harold A. Prada-Ramírez, Ángela Aurora BeltrÁn-Osuna, Sandra Celeita, Juan Camilo Fonseca

PDA Journal of Pharmaceutical Science and Technology Jul 2023, 77 (4) 268-280; DOI: 10.5731/pdajpst.2021.012632

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Keywords

Alternative microbiological methods (AMM)
Rapid microbiological methods (RMM)
Validation testing
Yeast and mold quantification
Microbiological quality control

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Performance Equivalence and Validation of a Rapid Microbiological Method for Detection and Quantification of Yeast and Mold in an Antacid Oral Suspension

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