Interlaboratory comparison about feasibility of insoluble particulate matter test for injections with reduced test volume in light obscuration method

Publication date: Available online 13 December 2018Source: BiologicalsAuthor(s): Akira Harazono, Hiroko Shibata, Masato Kiyoshi, Takashi Muto, Jun Fukuda, Tetsuo Torisu, Satoshi Saitoh, Hirotaka Nishimura, Susumu Uchiyama, Akiko Ishii-WatabeAbstractInsoluble 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.

Source: Biologicals - December 13, 2018 Category: Biology Source Type: research