PSMA-11 GMP

PSMA-11 GMP Grade

Product name: PSMA-11 (TFA salt)

Precursor for radiometal-labelled PSMA-11

Targeting of the prostate-specific membrane antigen for imaging

Molecular weight: 947.0 [g/mol]

Molecular formula: C44H62N6O17

PSMA-11 (GMP Grade)

General Information

Product No.: 50199
Product name: PSMA-11 (TFA salt)
Synonyms: Gozetotide, PSMA-HBED, Glu-Urea-Lys(Ahx)-HBED-CC
Sequence: HO-Glu-CO-Lys(Ahx-CC-HBED)-OH
Molecular weight: 947.0 [g/mol]
Molecular formula: C44H62N6O17
CAS No.:  1366302-52-4


Product Description

Enantiomerically pure, chemical precursor for radiopharmaceutical preparations with [68Ga].
For use by qualified personnel only.

Quantity

Product No. 50199: 40 µg net peptide

Packaging

Clear tubular glass vials type I (borosilicate, 2 mL) with lyophilisation stoppers and closed with aluminium caps.

Storage and Stability

Storage at -20°C (± 5°C). Protect from light.
A temperature increase up to +25°C over a period of ≤4 days does not affect the purity of the chemical precursor.

Certificates

Certificate of Analysis
Certificate of Compliance

Manufactured in full compliance with current EU GMP requirements. Specifications according to Ph. Eur. 2902 “Chemical precursors for radiopharmaceutical preparations”.

Literature

[1] Rodnick, M. E., et al., Synthesis of 68Ga-radiopharmaceuticals using both generator-derived and cyclotron-produced 68Ga as exemplified by [68Ga]Ga-PSMA-11 for prostate cancer PET imaging, Nature Protocols 2022, 17, 980-1003.

[2] Siebinga, H. et al., The Impact of Peptide Amount on Tumor Uptake to Assess PSMA Receptor Saturation on 68Ga-PSMA-11 PET/CT in Patients with Primary Prostate Cancer, J. Nucl. Med. 2023, 64(1), 63-68.

[3] olde Heuvel, J, et al., Day-to-day variability of [68Ga]Ga-PSMA-11 accumulation in primary prostate cancer: effects on tracer uptake and visual interpretation, EJNMMI 2020, 10, 132.

[4] Meijer, D. et al., Biochemical Persistence of Prostate-Specific Antigen After Robot-Assisted Laparoscopic Radical Prostatectomy: Tumor Localizations Using PSMA PET/CT Imaging, J. Nucl. Med. 2021, 62(7), 961-967.