Table 3 DP process qualification results

Radiochemical purity by HPLC-beta ram detector

NLT 96.0% area

100.0% area

Assay (% label claim) by HPLC-UV^a

90.0–110.0% w/w

98.5% w/w

Chemical Purity by HPLC-UV^a

NLT 96.0% area (Total impurities NMT 4.0% area)

99.7% area (Total impurities 0.31% area)

Radioactive concentration by LSC (Target 1.0 µCi/dose)

80.0–120% target

99.1%