Quality parameters
• Appearance: White solid
• Identification:
– HPLC: Retention time of main peak corresponds to PSMA I&T standard
– Mass spectrometry: m/z = 1498.4 ± 4
• Residual heavy metals (ICP-OES): ≤ 100 ppm
• Purity (HPLC): ≥ 98.0%
• Bacterial endotoxins (gel-clot method): ≤ 10.0 EU/vial
• Sterility (direct inoculation method): Sterile (passes test)
Sterility tests are performed for sterile products, made in aseptic conditions (class A).