PQ Check Standard, USP Count Reference Standard Surrogate

061UI-125 & 061UI-250 & 061UI-500 &061UI-1000

PQ Check Standard, USP Count Reference Standard Surrogate 

  • Designed specifically to mimic the USP Count Reference Standard (USP CRS) used during annual calibrations of Light Obscuration (LO) particle counters running USP <788> sub-visible particle count tests on parenteral preparations, this standard is used to verify the performance of an LO instrument performing this test.
  • While it cannot be used in place of the USP CRS, this product should be used as a PQ Check in between annual calibrations to ensure the LO instrument is accurately counting particles in parenteral products. By running this standard weekly or bi-weekly, any out-of-specification (OOS) results can quickly be investigated and the instrument making the measurement can easily be ruled out (or confirmed) as the root cause of the OOS result.
    • Standard material: NIST traceable size Polystyrene latex (PSL) spheres.
    • Nominal size and concentration of standard particles:
      • 15 µm PSL – 3,750 particles/mL
    • Product batch will be ± 10% of the nominal concentration; individual standard bottles will be certified ± 15% of the mean concentration and particle sizes are certified ± 5% of the standard size (± uncertainty)
  • The Certificate of Analysis includes actual concentration testing data and mean size.

 

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Volume

125 mL, 250 mL, 500 mL, 1000 mL

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