描述
USP<729> PQ Check Standard: Bi-Mix High Concentration
5um聚苯乙烯微球：400,000 particles/mL
10um聚苯乙烯微球：200,000 particles/mL
The MML Bi-Mix USP <729> high-concentration particle count standard #061UF-0125 provides the user with a pre-mixed Standard Preparation sample containing 5 μm and 10 μm polystyrene latex spheres (PSL) at concentrations suitable for Light Obscuration (LO) instruments equipped with an automated dilution system. This standard is designed to make it easy for the user to perform the required PQ Check prior to executing the USP <729> Method II Large Globule Content (i.e. PFAT-5) Test by LO. Each 125 mL bottle will contain the following nominal sizes and concentrations of polystyrene latex (PSL) spherical particles: 400,000 particles/mL of 5 μm spheres 200,000 particles/mL of 10 μm spheres The mean size of each included particle is NIST traceable. Usage instructions and a Certificate of Analysis are both included that specifies the concentration of each sphere to ± 22% (This uncertainty includes the uncertainty of the instrument as well as the standard concentration).
