621 USP CHAPTER

According USP general Chapter 621 which parameter not adjust ?

  • Detector wavelength : Adjustment not permitted

  • Defined Sensitivity of MP
  • Change wave length some  IMP may go missing
  • Responses might be different
  1. Stationary phase: No change (eg not replacement C18 b C8 )

    • Change RT
    • Change Selectivity
    • Change Elution respectively peck
    • RRT change RRF change miss identified IMP
  2. Particle size for packed column (In case GC): Maximum reduction of 50% ;

    • No Increase permitted
    • If increase particle size surface of column increase so poor RT meet hence not increase particle size
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