
The test results of interfering factors in 68Ga-DOTATOC injection
Test | Method | Acceptance criteria | Result |
---|---|---|---|
pH | pH meter | 4∼8 | 4 |
Chemical purity | HPLC | HEPES<200 μg/V | 10∼50 μg/mL |
Residual solvents | Gas chromatography | Ethanol: ≤10% (v/v) | 5.8%±0.5% |
Abbreviations: HPLC, high-performance liquid chromatography; HEPES, 4-(2-hydroxyethyl) piperazine-1-ethanesulfonic acid; V, maximum recommended dose in milliliters; v, volume.