Thermo Scientific™ PHARM-TROL™ Count Precision Size Standards

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

Supplier:  Thermo Scientific™ CSBX

Catalog No. 09-980-236

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

• Additive: Contains trace amount of surfactant
• Content And Storage: Unless otherwise stated, refrigerate 2° to 8deg;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.
• Description: Used by manufatures of parenteral drugs and ophthalmic solutions who are seeking interim verification of USP <788> and <789>.
• For Use With (Application): USP Verification
• Product Type: Count Control Particles
• Particle Density: 1.05g/cm³
• Refractive Index: 1.59 at 589nm (25°C)
• Stability: Product stable for a minimum of 12 months

• Concentration: 3800 particles/mL ± 15%
• Contents: Polystyrene microspheres in water
• Color: White or Colorless
• Material: Polystyrene
• Includes: Certificate of Calibration and Traceability to NIST
• Quantity: 20 x 25 mL Bottles
• Size Distribution: <3%
• Diameter (Metric): 15 μm