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PQ Check Standard, Tri-Mix Verification Standard for USP <789> Applications

061L-0250 & 061L-0500

PQ Check Standard, Tri-Mix Verification Standard for USP <789> Applications

  • Designed specifically as a tri-modal PQ check standard for automated Light Obscuration particle counting systems being used for USP <789> ophthalmic product particulate testing applications.
  • Volume: 250 mL 
  • HDPE Bottle w/PP Cap
  • Standard material: NIST traceable size Polystyrene latex (PSL) spheres
  • Nominal sizes and concentrations of standard particles:
    • 10 µm PSL – 1,000 particles/mL
    • 25 µm PSL – 500 particles/mL
    • 50 µm PSL – 100 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

250 mL, 500 mL

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    • 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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