USP789眼用注射剂中的不溶性微粒

USP789眼用注射剂中的不溶性微粒

Performance qualification particle standard

性能验证（PQ）标准粒子

这个粒子根据Micro Measurement Laboratories,IncZui新版本的H061标准操作流程进行生产的， preparation ofualification particle standards

货号660-1025，标准粒子 TRI MIX FOR APS and AD COUNT STANDARD(0.8, 2 and 5 μm) MML 125mL 061A

061A- PQ Check Standard, Tri-Mix for PSS Accusizer™ Autodiluter / APS Configuration

PQ Check Standard, Tri-Mix for PSS Accusizer™ Autodiluter / APS Configuration

• Tri-modal PQ check standard designed to verify size and count accuracy of the

Particle Sizing Systems (PSS) Accusizer model 780 SPOS instrument in the AD / APS configuration

• Volume: 125 mL

• Standard material: NIST traceable size Polystyrene latex (PSL) spheres

• Nominal sizes and concentrations of standard particles:

• 0.8 μm PSL – 1,250,000 particles/mL

• 2 μm PSL - 450,000 particles/mL

• 5 μm PSL - 150,000 particles/mL

• Product batch will be ± 10% of the nominal concentration; individual standard bottles will be certified ± 22% of the mean concentration and particle sizes are certified ± 5% of the standard size (± uncertainty)

• The Certificate of Conformance includes actual concentration testing data and mean size

性能验证标准，PSS Accusizer™自动稀释器/APS配置的

• 三模态PQ检查标准，用于验证尺寸与数量的准确性

粒径分析系统（PSS）Accusizer 780 SPOS仪器，采用AD/APS配置

• 体积：125毫升

• 标准材料：可追溯至NIST标准的聚苯乙烯乳胶（PSL）微球

标准颗粒的名义尺寸与浓度：

• 0.8微米PSL – 1,250,000个颗粒/毫升

• 2微米PSL - 450,000颗粒/毫升

• 5微米PSL - 15万颗粒/毫升