Quality Control Testing of 111In-DTPA-hEGF Injection
| Test | Specification | Radiopharmaceutical lot | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 35-07/09/02 | 43-08/12/02 | 39-09/03/02 | 52-09/09/02 | 43-09/16/02 | 42-10/08/02 | 45-10/29/02 | 46-10/28/02 | |||||||||
| Radioactivity (MBq) | <3,083 | 220 | 151 | 318 | 151 | 115 | 168 | 129 | 132 | |||||||
| pH | 5.5–6.5 | 6.5 | 6.5 | 6.5 | 6.0 | 6.0 | 6.0 | 6.0 | 6.0 | |||||||
| Radiochemical purity (%) | >90 | 94 | 97 | 97 | 96 | 99 | 98 | 96 | 98 | |||||||
| Radionuclidic purity (%) | >99.9 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | |||||||
| Clarity and color | Clear and colorless | Passed | Passed | Passed | Passed | Passed | Passed | Passed | Passed | |||||||
| Sterility | USP XXV | Passed | Passed | Passed | Passed | Passed | Passed | Passed | Passed | |||||||
| Apyrogenicity | USP XXV | Passed | Passed | Not tested | Not tested | Not tested | Passed | Not tested | Not tested | |||||||