小容量注射液和注射用无菌粉末中不溶性微粒的测定方法研究
Study on determination of particulate matter in small volume injections and sterile powder for injection
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摘要: 目的 研究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的测定方法。方法 分别采用全体积取样法、合并内容物直接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。结果 不同测定方法结果存在差异,不同仪器测定结果略有差异,大多数测试样品能符合规定,即每瓶含≥10μm的微粒数不超过6000个,含≥25μm的微粒数不超过600个。结论 制定不溶性微粒检查的品种,应在该品种项下具体指出测定方法。小容量注射液可根据样品性质分别采用合并直接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。Abstract: Objective To establish a light observation method for determination of particulate matter in small volume injections and sterile powder for injection. Methods 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 diluent. Results The different data were obtained with different sampling plans, and various results were found between two instruments. Most of parenral injection samples met the requirements, i. e. not more than 6000 at≥10μm and not more than 600 at≥25μm were found per vial. Conclusions The sampling method should be specified in the individual monographs. Small volume injections may be tested using the pooled sample and the diluting sample with an appropriate diluent and sterile powder for injection should be dissolved and diluted with the specified volume of filtered water or an appropriate filtered diluent based on consideration of product characteristics.
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