注射剤中の微粒子及びサブミクロン粒子の測定法

概要

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Since Teflon-laminated rubber closure was employed in parenteral drug preparations by many manufacturers, the particle contamination has been very improved. And many problems for inspection method on particulate matters have been ascertained up to this day. 1. The response of sensor was different according to the type of particle counter. So it is considered that the particle count obtained are different values. The specification of particle counter is important. 2. The instruments such as microscope, scanning electron microscope and energy dispersing X-ray microanalyzer were used on identification of particles. The inspection method using the special funnel with 4 mmφ in diameter makes easy identification for particulate matters. 3. On protein, peptides and antbiotics preparations, the polymer substances that were generated by gel formation or by polymerization of degradation product during lyophilization process and dissolution step, were observed. The results obtained from NICOMP submicron particle sizer gave much information for gel formation or polymerization in parenteral preparation.
1990-06-20