Thermo Scientific™ PHARM-TROL™ Count Precision Size Standards Available on GSA/VA Contract for Federal Government customers only.

Document the reproducibility of a particle counter by permitting a continuous record of its performance.

Manufacturer: Thermo Scientific™ CSPK

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Catalog No. 09-980-235

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    Specifications

    Additive Contains trace amount of surfactant to inhibit agglomeration and promote stability
    Composition Polystyrene
    Concentration 3800 particles/mL ± 15%
    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>.
    Diameter (Metric) 15μm
    Diameter (Metric) Particle 15.0 ± 0.2µm
    Includes Certificate of Calibration and Traceability to NIST
    Material Polystyrene
    Particle Density 1.05g/cm3
    Quantity 6 x 25mL bottles
    Refractive Index 1.59 at 589nm (25°C)
    Size Distribution <3%
    Stability Product stable for a minimum of 12 months
    Storage Requirements 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.
    Type Count Control Particles
    For Use With (Application) USP Verification

    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

  • Description & Specifications

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