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제 품 명 : PHARM-TROL™, Count Standards, Polystyrene
제 조 사 : Thermo
제품코드 : CS-PK
 
   
상세설명
 
PHARM-TROL™ Count Precision Size Standards

Thermo Scientific Pharm-Trol Count Precision Size Standards are for USP <788> and <789> verification.
These ready-to-use precision standards are 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.
 
Pharm-Trol 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> verification (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.
 
Recommended for: Particle count control for USP <788> and <789> verification
 
Specifications  
Composition Polystyrene
Particle Size 15.0µm ± 0.2µm
Uniformity <= 2% CV
Concentration 3800 particles/mL ± 15%
Density [Particle] 1.05 g/cm3
Refractive Index 1.59 @ 589nm (25°C)
Size[s] (bottle) 25mL
Content[s] Polystyrene microspheres in water
Additive Trace amount of surfactant to inhibit agglomeration and promote stability
Stability Product stable for a minimum of 12 months
Includes Certificate of Calibration and Traceability to NIST, Material Safety Data Sheet (MSDS)
Storage Requirements Store between 4 and 30°C. Do not freeze the particle suspension. Store upright and keep bottle tightly sealed to avoid contamination. Throughly disperse per protocol prior to use.

Cat. No.
Quantity
CS-PK 6 x 25mL bottles
CS-BX 20 x 25mL bottles
 
 
 

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