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Descripción
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
Especificaciones
Especificaciones
| Additive | Contains trace amount of surfactant to inhibit agglomeration and promote stability |
| Concentration | 3800 particles/mL ± 15% |
| Content And Storage | 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. |
| Contents | Polystyrene microspheres in water |
| Description | Used by manufacturers of parenteral drugs and ophthalmic solutions who are seeking interim verification of USP <788> and <789>. |
| Color | White or Colorless |
| For Use With (Application) | USP Verification |
| Material | Polystyrene |
| Product Type | Count Control Particles |
| Includes | Certificate of Calibration and Traceability to NIST |
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