Table 1. USP particle limits for injectable solutions4.
No. of 10 µm particles | No. of 25 µm particles | |
USP Test 1.A (for volumes >100 mL) | <25 per mL | <3 per mL |
USP Test 1.B (for volumes <100 mL) | <6,000 per container volume | <600 per container volume |