OpenLegislation

Division 2.1 Definitions

United Kingdom

Original text. Later amendments are not shown.

For the purpose of this Annex the following definitions shall apply:

Solvent free mass
  • The mass of the material after abstraction of the solvent, which normally is water.

  • Volatile fraction
  • The part of the solvent free mass, which is volatile and analysable by gas chromatography.

  • Identification of a primary product
  • Results of a descriptive analysis, which identifies substances present in the primary product.

  • Characterisation of a primary product
  • Identification of the major physical-chemical fractions and quantification and identification of the chemical constituents.

  • LOQ
  • Limit of Quantification

  • LOD
  • Limit of Detection

  • Si
  • The single-laboratory standard deviation, calculated from results generated under repeatability conditions as defined in ISO standard 5725-1f1 (= repeatability standard deviation estimated in a single laboratory approach according to the Harmonized Guidelines for Single-Laboratory Validation of Methods of Analysisf2).

  • Sr
  • The average within laboratory standard deviation, calculated from results generated under repeatability conditions as defined in ISO standard 5725-1 in a collaborative trial with a minimum of eight laboratories conducted according to the Protocol for the Design, Conduct and Interpretation of Method-Performance Studiesf3.

  • SR
  • The between laboratory standard deviation, calculated from results under reproducibility conditions as defined in ISO standard 5725-1 and according to the Protocol for the Design, Conduct and Interpretation of Method-Performance Studies.

  • RSDi
  • Relative single-laboratory repeatability standard deviation (Si expressed in percent of the measured value),

  • RSDr
  • Relative average repeatability standard deviation (Sr expressed in percent of the measured value),

  • RSDR
  • Relative reproducibility standard deviation (SR expressed in percent of the measured value).

  • Annotations

    Footnotes

    f1

    ISO 5725-1: Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions. Geneva, 1994.

    f2

    Thompson, M., S.L.R. Ellison, and R. Wood, Harmonized Guidelines for Single-Laboratory Validation of Methods of Analysis. Pure and Applied Chemistry, 2002. 74(5): pp. 835-855.

    f3

    Horwitz, W., Protocol for the design, conduct and interpretation of method-performance studies. Pure and Applied Chemistry, 1995. 67(2): pp. 331-343.