摘要
采用光阻法对小容量注射液和注射用无菌粉末中的不溶性微粒进行检查研究。分别采用直接全体积测定法、合并内容物测定法以及用适当溶剂稀释后测定法,测定每个容器中≥10μm和≥25μm的微粒数。用不同测定方法、不同仪器测定不溶性微粒,数据存在差异,但不影响22个品种的结果和判定,即每瓶中含10μm以上的微粒不超过6000粒,含25μm以上的微粒不超过600粒。小容量注射液可根据样品性质分别采用直接全体积测定法、合并内容物测定法或用适宜溶剂稀释后测定法,注射用无菌粉末可根据样品溶解度选用合适溶剂溶解稀释后测定。
To study and discuss for using light observation method for determination of particulate matter in small volume injections and sterile powder for injection. The average numbers of particles at ≥10μm and at ≥25μm in diameter in each unit were counted, using the sampling plans of the entire unit volume sample, the pooled sample and the diluting sample with an appropriate diluents. The different data were obtained with different sampling plans, and various results were found between different instruments. 22 iniection samples met the requirements, i. e. not more than 6 000 at ≥10 μm and not more than 600 at ≥25μm were found per vial. Small volume injections may be tested using the pooled sample and the diluting sample with appropriate diluents and sterile powder for injection should be dissolved and diluted with the specified volume of filtered water or appropriate filtered diluents based on consideration of product characteristics.
出处
《中国药事》
CAS
2008年第6期501-503,共3页
Chinese Pharmaceutical Affairs
关键词
小容量注射液
注射用无菌粉末
不溶性微粒
光阻法
small volume injections
sterile powder for injection
particulate matter
light observation method
