PHARM-TROL™ Count Precision Size Standards
PHARM-TROL™ Count Precision Size Standards
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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.
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Catalog NumberDiameter (Metric)Quantity
CS-BX15 μm20 x 25 mL Bottles
CS-PK15.0 ±0.2 μm6 x 25 mL Bottles
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Catalog number CS-BX
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Diameter (Metric):
15 μm
Quantity:
20 x 25 mL Bottles
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
AdditiveContains trace amount of surfactant
Concentration3800 particles/mL ± 15%
ContentsPolystyrene microspheres in water
DescriptionUsed by manufatures of parenteral drugs and ophthalmic solutions who are seeking interim verification of USP <788> and <789>.
ColorWhite or Colorless
For Use With (Application)USP Verification
MaterialPolystyrene
Product TypeCount Control Particles
IncludesCertificate of Calibration and Traceability to NIST
Particle Density1.05g/cm3
Quantity20 x 25 mL Bottles
Refractive Index1.59 at 589nm (25°C)
Size Distribution<3%
StabilityProduct stable for a minimum of 12 months
Diameter (Metric)15 μm
Unit SizeEach
Contents & 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.