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wittyboy

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[½»Á÷] ÇëÎÊÔÚÉ«Æ×·ÖÎöµÄ·½·¨Ñ§ÆÀ¼ÛÖÐSelectivity ºÍSpecificity Çø±ðÊÇʲô£¿

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The  term  selectivity  is  often  confused  and  incorrectly
used with  the  term specificity, especially  in  the  field of
chromatographic  analytical  methods.  


Selectivity:  the  selectivity  of  an  assay  is  a measure  of
the extent  to which  the method can determine a parti-
cular compound in the analysed matrices without inter-
ference from matrix components. A method that is per-
fectly  selective  for  an  analyte  or  group  of  analytes  is
specific¡£
Specificity: the validation procedure should confirm the
ability of  the method  to unequivocally  assess  the  ana-
lyte  in  the presence of other  components  that may be
present  (for example,  impurities, degradation products
and  matrix  components).  The  necessary  validation
studies depend on the method¡¯s use. Lack of specificity
of  an  individual  analytical procedure may be  compen-
sated  by  other  supporting  analytical  procedures  [2].
This  definition  from  the  International  Conference  on
Harmonization  (ICH)  is  restricted  to pharmaceuticals,
including active substances and formulations. However,
in  the  fields of bioanalysis  (analysis of analytes  in bio-
logical matrices and  in bioavailability  studies)  the  spe-
cificity  is completely neglected.
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