Typical Specifications for Quality Control Tests
| Test | Specification |
|---|---|
| Radiochemical purity (HPLC) | >95% |
| Radiochemical identity (HPLC) | tR ± 5% reference standard |
| Appearance (visual inspection) | Clear, colorless, particulate-free |
| pH | 4.0–7.0 |
| Endotoxin content (USP <85>) | <175 EU/injected dose |
| Filter integrity (bubble point) | According to filter manufacturer |
| Sterility | Sterile after 14 d |
EU = endotoxin units; HPLC = high-performance liquid chromatography; tR = retention time; USP = U.S. Pharmacopeia.