TABLE 1

PSMA-11 Precursor Specifications

CriteriaAcceptance
Specific filling
 Amount of filling1 mg ± 10%
 Identity (HPLC)Reference retention time ± 0.5 min
 Impurities (HPLC)Any unspecified impurity ≤ 2.0%
Total impurities ≤ 6.0%
 Bioburden/vialTAMC ≤ 100 cfu
TYMC ≤ 10 cfu
 BET (LAL)≤ 10 IU/vial
Bulk precursor batch
 AppearanceWhite to off-white solid
 Monoisotopic mass (net peptide)946.1 ± 1 m.u.
1H-NMRConforms to structure
13C-NMRConforms 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.