Alexander D M, Veltman A M
Department of Pharmacy, University of Durban-Westville, Republic of South Africa.
J Pharm Pharmacol. 1988 May;40(5):358-9. doi: 10.1111/j.2042-7158.1988.tb05266.x.
The particulate contamination in 12 formulations of antibiotic solutions in vials packed as dry powders from five South African sources has been analysed quantitatively using a HIAC PC 320 light blockage particle analyser linked to a CMB 60 sensor. Results showed that the level of particulate contamination fell well within the limits set by the USP XXIst Edition for Small Volume Parenterals although four formulations contained some particles greater than or equal to 50 micron. There was no apparent difference between the quality of the same antibiotics from different sources or between vials of the same antibiotics packed in different strengths.
使用与CMB 60传感器相连的HIAC PC 320光阻颗粒分析仪，对来自南非五个来源、以干粉形式包装在小瓶中的12种抗生素溶液制剂中的颗粒污染物进行了定量分析。结果表明，尽管有四种制剂含有一些大于或等于50微米的颗粒，但其颗粒污染物水平完全在《美国药典》第21版规定的小容量注射剂的限度范围内。不同来源的同一种抗生素的质量之间，或同一抗生素不同强度包装的小瓶之间，没有明显差异。
