Development studies of captopril certified reference material

Authors

  • Raquel Nogueira Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Eliane Cristina Pires do Rego Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Marcus Vinicius Barreto Sousa Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Wagner Wollinger Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Thaís Elias da Silva Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Gabriela Fernandes Moreira Brazilian National Institute of Metrology, Standardization and Industrial Quality; Materials Metrology Division
  • Juliano Smanioto Barin Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Luciane Varini Laporta Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Márcia Foster Mesko Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Celso Figueiredo Bittencourt Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Janaína Marques Rodrigues Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Valnei Smarçaro da Cunha Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory

DOI:

https://doi.org/10.1590/S1984-82502011000200015

Keywords:

Captopril^i1^squalitative analy, Medicines^i1^sCertified Reference Standa, Medicines^i1^sanalytical quality cont, High Pressure Liquid Chromatography (HPLC)^i1^squalitative analy, Medicines^i1^scontaminat

Abstract

This paper describes the studies performed with the candidate Certified Reference Material (CRM) of captopril, the first CRM of an active pharmaceutical ingredient (API) in Brazil, including determination of impurities (organic, inorganic and volatiles), homogeneity testing, short- and long-term stability studies, calculation of captopril content using the mass balance approach, and estimation of the associated measurement uncertainty.

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Published

2011-06-01

Issue

Section

Articles

How to Cite

Development studies of captopril certified reference material . (2011). Brazilian Journal of Pharmaceutical Sciences, 47(2), 339-350. https://doi.org/10.1590/S1984-82502011000200015