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PQ Check Standard, 10 µm Count and Size Standard
600-LA0125
PQ Check Standard, 10 µm Count and Size Standard
- Volume: 125 mL
- Each unit will nominally contain 1 size of Polystyrene Latex (PSL) spheres:
- Approximately 1,000,000 particles/ mL of 10 µm PSL
- Product batch will be ± 10% of the stated concentration.
- Product batch will be ± 10% of the nominal concentration; individual standard bottles will be certified ± 22% 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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- 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.
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- 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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PQ Check Standard, 10 µm Particle Count and Size Standard
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- The Certificate of Analysis includes actual concentration testing data and mean size