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Home  >  Test Service   >  Method Validation

Method Validation
Residual Solvents test method validation
Instrument:Agileng 6890N(TCD,FID)
      Design and Development Qualification: Agilent
      Installation Qualification: Agilent
      Operational Qualification: Agilent
      Performance Qualification:Agilent
Validation Items: System Suitability, Precision (Repeatability, Intermediate Precision), Specificity,
             Linearity, Accuracy, Quantitation Limit and Detection Limit, Range
System suitability: Resolution (R) ≥2.0
             RSD ≤3.9891*(%of analyte)-0.1502
Precision:   Repeatability  RT RSD ≤3.9891*(%of analyte)-0.1502
             Peak area  RSD ≤3.9891*(%of analyte)-0.1502
          Intermediate precision: By different persons in the same day   
             RSD ≤3.9891*(%of analyte)-0.1502
             By the same person in the different days 
             RSD ≤3.9891*(%of analyte)-0.1502
Specificity:
          R. ≥2.0
          Recovery between 90%-110%
Linearity:
          The linearity range is from 50% of residual solvent limit to 200% of the limit.
          For each solvent R ≥ 0.995
LOD:
        Signal / Noise ≥ 3
LOQ:
        Signal / Noise ≥ 10
Accuracy:    
        Recovery was between 90% and 110%

Other method validation services
Method validation for Quality impurities, Quantity impurities, Assay, water, specificrotation, identification

A lot of methods or equipments could be involved such as: HPLC, GC, UV, Polarmeter, KF water, titration and so on.

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