[Determination of particulate matter in small volume antibiotic injections]

Amounts of particulate matter present in 17 small volume antibiotic injections marketed in Japan were determined using light obscuration particle analyzer (HIAC). The vial volume range of each batch of product was 7-20 ml, and each vial contained 1 g as antibiotic potency. In 4 products, contents of particles between 2.5 and 10 microns in diameter were counted 2,000-7,000 per vial, and particles in other products were counted less than 2,000 per vial. Numbers of particles greater than or equal to 10 microns in diameter were much less than the USP XXI criteria for particulate matter in small volume injections. The product of the highest counts for particles between 10 and 25 microns in diameter showed counts amounted to 0.13% of the USP XXI criteria. In the 25-50 microns particulate diameter range, particulate matters were detected only in 2 products, and they were less than 0.2% of the USP XXI criteria. Particles over 50 microns in diameter were not detected in any products. These results showed that 17 small volume antibiotic injections marketed in Japan had good qualities regarding contents of particulate matter.