SPDS 09052014

8/22/2014

Determination of Total CS SMPR

Screening Method for Adulterants in CS SMPR

Parameter  Requirements

Target Test  Concentration (w/w)

Minimum Acceptable  Results

Parameter

Minimum of 33  replicates presenting all  target compounds in  Annex I  and  all matrix  types listed in Annex II  ,   spiked at or below the  designated low level  target test  concentration High concentration.   Minimum of 5  replicates per matrix  type spiked at the  designated high level  target test  concentration. Zero concentration.    Minimum of 5  replicates per matrix  type that have tested negative with a second  method and have not  been spiked. Use Appendix N: ISPAM  Guidelines for  Validationof 

≤ 5%

90% POD  (1) of the  pooled data for all  target compounds and  matrices.

Matrix  Studies (1)

ca. 20%

100% correct analyses  are expected per  matrix type (2)

Single laboratory validation

0 %

≤ 5% 

≥ 0.85 ≥ 0.95 

LPOD

ca. 20% 

Qualitative Binary  Chemistry Methods

LPOD (0)

0 %

≤ 0.05

laboratory  study

Multi‐

Notes: (1)

95%confidence interval (2)100%correctanalyses areexpected.  Some aberrations may be acceptable if the aberrations are investigated, andacceptable explanations  canbe determined and communicated tomethod users(3)  LPODandLPOD  (0) arenot required for First Action Official Methods ofAnalysis  approval.

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