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THERMO SCI PARTICLE TECHNOLOGY
PHARM-TROL™ Count Precision Size Standards
Document the reproducibility of a particle counter by permitting a continuous record of its performance.
| Catalog Number | Diameter (Metric) | Quantity |
|---|---|---|
| 09980235 | 15.0 ±0.2 μm | 6 x 25 mL Bottles |
Catalog number 09980235
Price (USD)
-
Diameter (Metric):
15.0 ±0.2 μm
Quantity:
6 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
Diameter (Metric)15.0 ±0.2 μm
AdditiveContains trace amount of surfactant to inhibit agglomeration and promote stability
Refractive Index1.59 at 589nm (25°C)
ContentsPolystyrene microspheres in water
Quantity6 x 25 mL Bottles
IncludesCertificate of Calibration and Traceability to NIST
MaterialPolystyrene
DescriptionUsed by manufacturers of parenteral drugs and ophthalmic solutions who are seeking interim verification of USP <788> and <789>.
Size Distribution<3%
StabilityProduct stable for a minimum of 12 months
ColorWhite or Colorless
For Use With (Application)USP Verification
Product TypeCount Control Particles
Concentration3800 particles/mL ± 15%
Particle Density1.05g/cm3
Unit SizePK
Contents & 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.