PHARM-TROL Count Precision Standard

  PHARM-TROL Count Precision Standard



The ready-to-use precision standard is designed for regular use in liquid particle counters.  This documents the reproducibility of the particle counter by permitting a continuous record of its performance using a NIST traceable microsphere suspension with a known concentration.  The data provides documentation for internal or customer audits.


   Product Detail


The product contains NIST traceable size standards with a measured particle count.  The product was developed for manufactures of parenteral drugs and ophthalmic solutions seeking interim verification of USP <788> and <789> (Particulate Matter in Injections and Particulate Matter in Ophthalmic Solutions).  The particle diameters are traceable to the Standard Meter through the National Institute of Standards and Technology (NIST).

PHARM-TROL™ is prepared with the same exacting procedures as the USP Count Reference Standard and provides process control data for particle counting consistency and verification of size calibration.

 PHARM-TROL Count Precision Standard
 PRODUCT# Price  Quantity  
       
 CS-PK      -    6 Bottles   SELECT  
 CS-BX      -    20 Bottles   SELECT  
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Specifications:
Particle Composition :Polystyrene
Particle Size :15 μm
Size Uniformity :≤ 2% CV
Concentration :3800 particles / mL ± 15%
Particle Density :1.05 g/cm³:
Index of Refraction :1.59 @ 589nm (25°C)
Bottle Size :25 mL
Content :Polystyrene microspheres in water
Additives :Trace amount of surfactant to inhibit agglomeration and promote stability
Expiration Date :≥ 12 months
Package Includes :Certificate of Calibration and Traceability to NIST,
Material Safety Data Sheet (MSDS)
Storage & Handling :Store between 4 and 30° C. Do not freeze the particle suspension. Store upright and keep bottle tightly sealed to avoid contamination. Thoroughly disperse per protocol prior to use.