TABLE 1.
PSMA-11 Precursor Specifications
| Criteria | Acceptance |
| Specific filling | |
| Amount of filling | 1 mg ± 10% |
| Identity (HPLC) | Reference retention time ± 0.5 min |
| Impurities (HPLC) | Any unspecified impurity ≤ 2.0% |
| Total impurities ≤ 6.0% | |
| Bioburden/vial | TAMC ≤ 100 cfu |
| TYMC ≤ 10 cfu | |
| BET (LAL) | ≤ 10 IU/vial |
| Bulk precursor batch | |
| Appearance | White to off-white solid |
| Monoisotopic mass (net peptide) | 946.1 ± 1 m.u. |
| 1H-NMR | Conforms to structure |
| 13C-NMR | Conforms to structure |
| Impurities (HPLC) | Any unspecified impurity ≤ 2.0% |
| Total impurities ≤ 3.0% | |
| Residual solvents (GC) | Acetonitrile ≤ 5,000 ppm |
| Tertbutylmethylether ≤ 5,000 ppm | |
| Water (GC) | ≤ 10% |
| Heavy metals (ICP-MS) | Iron ≤ 100 ppm; |
| Copper ≤ 100 ppm; | |
| Zinc ≤ 100 ppm; | |
| Palladium ≤ 100 ppm | |
| Assay (HPLC) | ≥50% |
| Trifluoroacetic acid (GC) | ≤40% |
HPLC = high performance liquid chromatography; TAMC = total anaerobic microbial count; TYMC = total yeast/mold count; BET = bacterial endotoxin test; LAL = limulus amebocyte lysate; NMR = nuclear MR; GC = gas chromatography; ICP-MS = inductively coupled plasma mass spectrometry.