Development of a new optical particle counter and its application in pharmaceutical analysis
A high-precision optical particle counter was introduced,which combines light obscuration and light scattering technologies,improving the measurement range and measurement precision of the apparatus.Cylindrical lens and roof prism characterize the design of the light source,resulting in a square-shaped laser beam whose thickness is only 20μm.The particle counting efficiency is therefore improved.The utilization of a mathematical model of smoothing comparator in terms of pulse signal extraction leads to not only effective signal noise filtration but also accurate extraction of the pulse number and intensity,and accurate calculation of the number and size of particles.The 95%coincidence error limit is 45000/mL,and the accurate five-peak distribution can be obtained by mixing the five standard particle size materials of 1.6,4.8,8,16,32 μm.Sodium chloride injection and fat emulsion were measured and verified.The content of insoluble particles in 0.9%sodium chloride injection from three manufacturers meets the requirements of the pharmacopoeia.In the three fat emulsion samples,the PFAT5 of G1 and G2<0.05%,which meets the requirements of the pharmacopoeia,qualified;However,the PFAT5 of G3>0.05%,which does not meet the requirements of the pharmacopoeia,unqualified.The above shows that the apparatus has a good application prospect in the medical analysis domain.
万方数据
维普
