development studies of captopril certified reference material
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ID: 144862
2011
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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.
Este artigo descreve os estudos realizados com o candidato a Material de Referência Certificado (MRC) de captopril, primeiro MRC de fármacos no Brasil, incluindo a determinação de impurezas (orgânicas, inorgânicas e voláteis), testes de homogeneidade, testes de estabilidade de curta e longa duração, cálculo do teor de captopril por balanço de massa e estimativa da incerteza de medição associada ao valor certificado.
Este artigo descreve os estudos realizados com o candidato a Material de Referência Certificado (MRC) de captopril, primeiro MRC de fármacos no Brasil, incluindo a determinação de impurezas (orgânicas, inorgânicas e voláteis), testes de homogeneidade, testes de estabilidade de curta e longa duração, cálculo do teor de captopril por balanço de massa e estimativa da incerteza de medição associada ao valor certificado.
| Reference Key |
nogueira2011braziliandevelopment
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|---|---|
| Authors | ;Raquel Nogueira;Eliane Cristina Pires do Rego;Marcus Vinicius Barreto Sousa;Wagner Wollinger;Thaís Elias da Silva;Gabriela Fernandes Moreira;Juliano Smanioto Barin;Luciane Varini Laporta;Márcia Foster Mesko;Celso Figueiredo Bittencourt;Janaína Marques Rodrigues;Valnei Smarçaro da Cunha |
| Journal | electronic engineering times |
| Year | 2011 |
| DOI |
10.1590/S1984-82502011000200015
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| URL | |
| Keywords |
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