小剂量样品不溶性微粒分析

2020/07/06   下载量: 0

方案摘要

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应用领域 制药/生物制药
检测样本 化药制剂
检测项目 限度检查>不溶性微粒
参考标准 USP

Single particle optical sizing (SPOS) is a particle size and count technique that provides results at high accuracy and resolution. Particles in liquid suspensions flow through a sensing zone illuminated by a laser beam. Each particle obscures and scatters the incident light source. With the AccuSizer LE-400 sensor, both the light obscuration and scattering are used to relate particle/ light interactions with particle size. Each particle is sized and counted one at a time, providing the concentration in particles/mL. The sample volume must also be accurate in order to generate accurate concentration data. This technical note presents data generated at customer request to prove the size, count, and volume accuracy of the AccuSizer SIS/Syringe Injection Sampler system.

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For certain applications, only a small volume of sample is available for analysis using multiple techniques. It isn’t   unusual, in pharmaceutical research, to have 1 mL or less of a protein-based sample and require many assays to be performed. The AccuSizer from Particle Sizing Systems is capable of measuring particle size and concentration at extremely low sample volumes, as proven in the data shown in this technical note. 

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