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Definitions of Quality Terms in Spectroquant® Certificates


For a Better Understanding of Our Documents

The following are definitions of quality terms used on Merck´s quality and lot certificates:

  • Sensitivity of the method – Slope of the calibration curve as defined in ISO 8466-1
  • Lower limit of detection – The smallest amount of a substance that can be detected qualitatively by measuring one time with a sufficient statistical probability. The lower limit of detection is a decision limit for the presence of a component. At the lower limit of detection there is a likelihood of 50 percent to find or not find the substance according to SM 1030 C.
  • Method detection limit – The smallest amount of a substance that can be detected quantitatively with one-time analysis based on a statistical probability of detectable level according to SM 1030 C.
  • Confidence interval with a 95 percent probability – Confidence interval is the level determined by a given probability of where the true value lies. Values of random sample surveys are associated in principle with uncertainty. They are estimates (albeit the best) of the unknown parameters of the population, which is the real interest. The advantage of measurement results using confidence intervals lies in the fact that the reliability of the results can be quantified according to ISO 8466-1.
  • Standard deviation of the method – Most commonly used measure of dispersion according to ISO 8466-1.
  • Variation coefficient of the method – Standard deviation related to the mean and is expressed in % according to ISO 8466-1.
 
 
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