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Thermo Scientific™ PHARM-TROL™ Count Precision Size Standards
Document the reproducibility of a particle counter by permitting a continuous record of its performance.
Brand: Thermo Scientific™ CS-PK
This item is not returnable.
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Description
Document the reproducibility of a particle counter by permitting a continuous record of its performance with Thermo Scientific™ PHARM-TROL™ Count Precision Size Standards, ready-to-use precision standards designed for regular use in liquid particle counters for USP <788> and <789> verification. Data is documented for internal or customer audits by using a NIST™-traceable microsphere suspension with a known concentration.
Features:
- Contains NIST™-traceable size standards with a measured particle count
- Developed for manufacturers of parenteral drugs and ophthalmic solutions seeking interim verification of USP <788> and <789> verification (Particulate Matter in Injections and Particulate Matter in Opthalmic Solutions)
- Particle diameters traceable to the Standard Meter through the National Institute of Standards and Technology
- Prepared with the same exacting procedures as the USP Count Reference Standard, providing process control data for particle counting consistency and verification of size calibration
Specifications
| Contains trace amount of surfactant to inhibit agglomeration and promote stability | |
| Unless otherwise stated, refrigerate (2° to 8°C) product when not in use but do not freeze. Store upright and keep bottle tightly sealed. Mix product with gentle inversion by hand or vortex mixer. | |
| Used by manufacturers of parenteral drugs and ophthalmic solutions who are seeking interim verification of USP <788> and <789>. | |
| USP Verification | |
| Count Control Particles | |
| 1.05g/cm3 | |
| 1.59 at 589nm (25°C) | |
| Product stable for a minimum of 12 months |
| 3800 particles/mL ± 15% | |
| Polystyrene microspheres in water | |
| White or Colorless | |
| Polystyrene | |
| Certificate of Calibration and Traceability to NIST | |
| 6 x 25 mL Bottles | |
| <3% | |
| 15.0 ±0.2 μm |