Data for: Collaborative study about feasibility of insoluble particulate matter test for injections with reduced test volume in light obscuration method.

Published: 25 February 2020| Version 1 | DOI: 10.17632/95b48nbskj.1
Akira Harazono, Masato Kiyoshi, Hiroko Shibata, Tetsuo Torisu, Jun Fukuda, Takashi Muto, Susumu Uchiyama, Akiko Ishii-Watabe, Hirotaka Nishimura, Satoshi Saitoh


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. Several studies about feasibility of light obscuration method with reduced volume were reported, and it is considered that single measurement volume can be reduced up to 0.2 mL by setting appropriate tare and pre-run volumes. However, the influences of reduction of measurement volume on accuracy and precision of light obscuration method has not been evaluated by multi-laboratory study. This study was carried out for examining the validity of the new general test of the insoluble particulate matter with reduced volume for therapeutic protein injections in Japanese Pharmacopoeia (JP), which was released for public consultation in 2017



Pharmaceutical Analysis