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Related Concept Videos

Uncertainty in Measurement: Reading Instruments02:46

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Counting is the type of measurement that is free from uncertainty, provided the number of objects being counted does not change during the process. Such measurements result in exact numbers. By counting the eggs in a carton, for instance, one can determine exactly how many eggs are there in the carton. Similarly, the numbers of defined quantities are also exact. For example, 1 foot is exactly 12 inches, 1 inch is exactly 2.54 centimeters, and 1 gram is exactly 0.001 kilograms. Quantities...
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All the digits in a measurement, including the uncertain last digit, are called significant figures or significant digits. Note that zero may be a measured value; for example, if a scale that shows weight to the nearest pound reads “140,” then the 1 (hundreds), 4 (tens), and 0 (ones) are all significant (measured) values.
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Uncertainty in Measurement: Accuracy and Precision03:37

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Scientists typically make repeated measurements of a quantity to ensure the quality of their findings and to evaluate both the precision and the accuracy of their results. Measurements are said to be precise if they yield very similar results when repeated in the same manner. A measurement is considered accurate if it yields a result that is very close to the true or the accepted value. Precise values agree with each other; accurate values agree with a true value. 
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Werner Heisenberg considered the limits of how accurately one can measure properties of an electron or other microscopic particles. He determined that there is a fundamental limit to how accurately one can measure both a particle’s position and its momentum simultaneously. The more accurate the measurement of the momentum of a particle is known, the less accurate the position at that time is known and vice versa. This is what is now called the Heisenberg uncertainty principle. He...
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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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Uncertainty: Overview00:59

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In analytical chemistry, we often perform repetitive measurements to detect and minimize inaccuracies caused by both determinate and indeterminate errors. Despite the cares we take, the presence of random errors means that repeated measurements almost never have exactly the same magnitude. The collective difference between these measurements - observed values - and the estimated or expected value is called uncertainty. Uncertainty is conventionally written after the estimated or expected value.
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Measurement uncertainty in pharmaceutical analysis and its application.

Marcus Augusto Lyrio Traple1, Alessandro Morais Saviano1, Fabiane Lacerda Francisco1

  • 1Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of São Paulo, São Paulo 05508-900, Brazil.

Journal of Pharmaceutical Analysis
|February 7, 2018
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Summary

Measurement uncertainty is crucial for pharmaceutical analysis, informing decisions on product compliance. This study evaluates uncertainty estimation for ensuring the quality and reliability of pharmaceutical products.

Keywords:
Measurement uncertaintyMethod validationPharmaceutical analysisQuality control

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Area of Science:

  • Pharmaceutical Analysis
  • Analytical Chemistry
  • Quality Control

Background:

  • Analytical results in the pharmaceutical industry are critical for compliance decisions.
  • Measurement uncertainty provides comprehensive information about analytical results.
  • Accurate uncertainty estimation is vital for regulatory and quality assurance processes.

Purpose of the Study:

  • To evaluate and discuss the estimation of measurement uncertainty in pharmaceutical analysis.
  • To highlight the importance of uncertainty in decision-making for pharmaceutical products.
  • To demonstrate the utility of uncertainty in assessing pharmaceutical equivalence and stability.

Main Methods:

  • Literature review on uncertainty estimation methodologies in pharmaceutical contexts.
  • Discussion of the application of uncertainty in compliance assessments.
  • Analysis of uncertainty's role in pharmaceutical equivalence and stability studies.

Main Results:

  • Measurement uncertainty offers complete information essential for analytical results.
  • Uncertainty is a key factor in determining compliance or non-compliance of pharmaceutical products.
  • Effective uncertainty estimation supports reliable assessments of pharmaceutical equivalence and stability.

Conclusions:

  • The estimation of measurement uncertainty is a fundamental aspect of pharmaceutical analysis.
  • Uncertainty quantification is indispensable for robust quality control and regulatory compliance.
  • Accurate uncertainty assessment enhances the reliability of pharmaceutical product evaluations.