Harazono Akira, Shibata Hiroko, Kiyoshi Masato, Muto Takashi, Fukuda Jun, Torisu Tetsuo, Saitoh Satoshi, Nishimura Hirotaka, Uchiyama Susumu, Ishii-Watabe Akiko
Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, Tonomachi 3-25-26, Kawasaki-ku, Kanagawa, 210-9501, Japan.
Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, Tonomachi 3-25-26, Kawasaki-ku, Kanagawa, 210-9501, Japan.
Biologicals. 2019 Jan;57:46-49. doi: 10.1016/j.biologicals.2018.12.003. Epub 2018 Dec 13.
Insoluble particulate matter test for injections in pharmacopoeia is mandatory for parenteral drug products. In this test using light obscuration, four measurements of at least 5-mL are required. Since therapeutic protein injections of low dosage volumes are getting more popular, reduction of test volumes is desired. In this collaborative study, the impact of lower measurement volume on the accuracy and precision of particle count was evaluated using 2, 5, 10, and 25-μm polystyrene count standards for the validity of test with reduced sample volumes. Good accuracy (3000 particles/mL ± 10%) was obtained at all measurement volumes, and the inter-run variability (RSD) was the same levels between 5 and 1 mL. Although the inter-run variability increased at 0.2 mL, it was below 5%. These results indicated that light obscuration method can be used with 5 mL-0.2 mL, and that it is feasible for monitoring particles ≥2 μm.
药典中注射剂的不溶性微粒检测对于注射用药品是强制性的。在这种采用光阻法的检测中，需要对至少5毫升的样品进行四次测量。由于低剂量体积的治疗性蛋白质注射剂越来越普遍，因此希望减少检测体积。在这项协作研究中，使用2、5、10和25微米的聚苯乙烯计数标准评估了较低测量体积对颗粒计数准确性和精密度的影响，以验证减少样品体积后的检测有效性。在所有测量体积下均获得了良好的准确性（3000个颗粒/毫升±10%），5毫升和1毫升之间的批间变异系数（RSD）处于相同水平。虽然在0.2毫升时批间变异系数增加，但低于5%。这些结果表明，光阻法可用于5毫升至0.2毫升的检测，并且监测≥2微米的颗粒是可行的。
