Introduction to measurement uncertainty in chemical analysis

Williams, Alex

doi:10.1007/s007690050196

Cited by 16 publications

(7 citation statements)

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“…This is because even the corrections applied have, by themselves, an associated uncertainty, not removing absolute uncertainty. Still, such a method of correction of uncertainty does not distinguish the variations from random effects, inherent to any experimental determination (Williams, 1998). Measurement uncertainty (MU) reflects a range of values that can be assigned to an AR using a specific methodology.…”

Section: Introductionmentioning

confidence: 99%

“…The first edition of the EURACHEM Guide entitled "Quantifying Uncertainty in Analytical Measurement" (Eurachem, 1995) was published in 1995. Focusing on various applications of analytical chemistry, from basic research up to routine analysis in major industries, the guide was well received by the analytical community (Williams, 1998). Five years later, EURACHEM/CITAC published the second version of the guide, emphasizing new concepts such as the integration of measuring uncertainty and in-house quality assurance procedures.…”

Section: Introductionmentioning

confidence: 99%

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Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations

Romero¹,

Lourenço²

2017

Braz. J. Pharm. Sci.

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Analytical results are widely used to assess batch-by-batch conformity, pharmaceutical equivalence, as well as in the development of drug products. Despite this, few papers describing the measurement uncertainty estimation associated with these results were found in the literature. Here, we described a simple procedure used for estimating measurement uncertainty associated with the dissolution test of acetaminophen tablets. A fractionate factorial design was used to define a mathematical model that explains the amount of acetaminophen dissolved (%) as a function of time of dissolution (from 20 to 40 minutes), volume of dissolution media (from 800 to 1000 mL), pH of dissolution media (from 2.0 to 6.8), and rotation speed (from 40 to 60 rpm). Using Monte Carlo simulations, we estimated measurement uncertainty for dissolution test of acetaminophen tablets (95.2 ± 1.0%), with a 95% confidence level. Rotation speed was the most important source of uncertainty, contributing about 96.2% of overall uncertainty. Finally, it is important to note that the uncertainty calculated in this paper reflects the expected uncertainty to the dissolution test, and does not consider variations in the content of acetaminophen.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations

Romero¹,

Lourenço²

2017

Braz. J. Pharm. Sci.

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“…The steps involved in uncertainty estimation are: (1) specification of measurand, (2) identification of uncertainty sources, (3) quantification of uncertainty components, and (4) calculation of combined and expanded uncertainty [4] , [24] , [25] . A summary of these steps is presented in Table 1 .…”

Section: Introductionmentioning

confidence: 99%

“… Quantification of uncertainty components Measure or estimate the uncertainty component associated with each potential source of uncertainty identified. These uncertainties may be obtained from method validation data, calibration certificate of instruments, purity of reagents and chemical reference substances and experimental studies [4] , [24] . Calculation of combined and expanded uncertainties Express all uncertainties components as standard deviations.…”

Section: Introductionmentioning

confidence: 99%

Measurement uncertainty in pharmaceutical analysis and its application

Traple

Saviano

Francisco

et al. 2014

Journal of Pharmaceutical Analysis

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The measurement uncertainty provides complete information about an analytical result. This is very important because several decisions of compliance or non-compliance are based on analytical results in pharmaceutical industries. The aim of this work was to evaluate and discuss the estimation of uncertainty in pharmaceutical analysis. The uncertainty is a useful tool in the assessment of compliance or non-compliance of in-process and final pharmaceutical products as well as in the assessment of pharmaceutical equivalence and stability study of drug products.

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“…Apesar dessas ações, um resultado analítico jamais será capaz de ser uma representação absoluta e perfeita do parâmetro medido. Sempre haverá uma incerteza associada a um resultado analítico, mesmo que todas as fontes de incerteza tenham sido avaliadas 1,5 . A incerteza de medição é um parâmetro que reflete o intervalo de valores que podem ser atribuídos ao que está sendo medido (mensurando), como por exemplo o teor de um ingrediente farmacêutico ativo.…”

Section: Introdução E Justificativaunclassified

Incerteza de medição na avaliação de desempenho de métodos analíticos e estratégias de melhoria com a aplicação do Analytical Quality by Design

Separovic¹

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À minha melhor amiga Talita, por estar presente nos momentos bons e ruins, pela amizade, companheirismo, apoio e por sempre torcer e acreditar em mim.À minha quase irmã Paula, por toda amizade, colaboração e apoio não somente ao longo da realização deste trabalho, mas na vida.Aos meus amigos e familiares, pela amizade, por toda ajuda e por acreditarem em mim.Ao meu orientador, Prof. Dr. Felipe, por todo ensinamento, atenção e por acreditar em meu potencial e sempre apoiar meu progresso. À Claudineia, Edgar, Elisabete e Rogério, pelos ensinamentos e assistência na realização prática deste trabalho. Ao Prof. Dr. André, por ser o primeiro a sugerir a mudança de nível do meu projeto, acreditando em seu potencial. Ao Prof. Dr. Ricardo da Universidade de Lisboa, pelas oportunidades de colaboração, ensinamentos e credibilidade. Ao secretário do programa, David, por toda assistência ao longo desses anos. À CAPES, pois o presente trabalho foi realizado com apoio da Coordenação de Aperfeiçoamento de Pessoal de Nível Superior -Brasil (CAPES) -Código de Financiamento 001. À Fapesp, pelo apoio financeiro concedido através do processo no 2018/25734-0, Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP). Finalmente, à Faculdade de Ciências Farmacêuticas, em especial ao Departamento de Farmácia, pela oportunidade de realização deste trabalho! "Somente a dose correta diferencia o veneno do remédio." Paracelso (1493-1541) RESUMO SEPAROVIC, L. Incerteza de medição na avaliação de desempenho de métodos analíticos e estratégias de melhoria com a aplicação do Analytical Quality by Design. 2021. 104p. Tese (Doutorado) -Faculdade de Ciências Farmacêuticas,

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Introduction to measurement uncertainty in chemical analysis

Cited by 16 publications

References 0 publications

Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations

Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations

Measurement uncertainty in pharmaceutical analysis and its application

Incerteza de medição na avaliação de desempenho de métodos analíticos e estratégias de melhoria com a aplicação do Analytical Quality by Design

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