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PQ Check Standard, USP <788> Microscopic Method Membrane Qualification Std.
061M
PQ Check Standard, USP <788> Microscopic Method Membrane Qualification Standard
- 25 mm, 0.8 µm pore size MCE membrane, grey, gridded or non-gridded
- Standard material: NIST traceable size Polystyrene latex (PSL) spheres
- Nominal sizes and concentrations of standard particles:
- 10 µm PSL – 300 particles per membrane
- 25 µm PSL – 30 particles per membrane
- Above concentrations are nominal; the Certificate of Analysis included with each membrane will show MML certified concentrations
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PQ Check Standard, 0.7 µm Single-Mode Peak, Polystyrene Latex (PSL) Beads
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PQ Check Standard, USP Count Reference Standard Surrogate
Select options This product has multiple variants. The options may be chosen on the product pagePQ 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.
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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; Bi-Mix Verification Standard; CMP application
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PQ Check Standard, Tri-Mix Verification Standard for USP <789> Applications
Select options This product has multiple variants. The options may be chosen on the product pagePQ 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