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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, Tri-Mix Verification Standard for USP <789> Applications
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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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Calibration Kit: PSS Accusizer™ LE400 Sensors-All Modes
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PQ Check Standard, Tri-Mix for PSS Accusizer™ Syringe Sampler (SIS) Configuration
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PQ Check Standard, Tri-Mix for PSS Accusizer™ Syringe Sampler (SIS) Configuration
- Tri-modal PQ check standard designed to verify size and count accuracy of the Particle Sizing Systems (PSS) Accusizer model 780 SPOS instrument in the Syringe Injection Sampler (SIS) configuration
- Standard material: NIST traceable size Polystyrene latex (PSL) spheres
- Nominal sizes and concentrations of standard particles:
- 0.8 µm PSL – 3,500 particles/mL
- 2 µm PSL – 800 particles/mL
- 5 µm PSL – 200 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, 5 & 10 µm Bi-Mix, USP <729 > Method 2, AD/APS
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PQ Check Standard, 5 & 10 µm Bi-Mix, USP <729 > Method 2 with Automatic Dilution
- Designed specifically with USP <729> requirements in mind, prior to executing the “”Method 2″” SPOS PFAT-5 test, this standard is used to verify the performance of a Single Particle Optical Sensing (SPOS) particle counter equipped with an automatic dilution system.
- Standard material: NIST traceable size Polystyrene latex (PSL) spheres.
- Nominal sizes and concentrations of standard particles:
- 5 µm PSL – 400,000 particles/mL
- 10 µm PSL – 200,000 particles/mL
- 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)
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