PSMA I&T GMP

800px-PSMA I&T

PSMA I&T
GMP grade

PSMA I&T (TFA salt)

Precursor for radiometal-labelled PSMA I&T

Prostate-specific membrane antigen for imaging & therapy

Molecular Weight:
1498.4 (av.)

Molecular Formula:
C63H92IN11O23

PSMA I&T (GMP Grade)

General Information

Product name: PSMA I&T (TFA salt)
Synonyms: (R)-DOTAGA-(I-y)fk(Sub-KuE)
Sequence: Suber-1-oyl-ε-(DOTA-GA-3-iodo-D-Tyr-D-Phe-D-Lys-OH)-8-oyl-ε-(HO-Glu-ureido-Lys-OH)
Molecular Weight: 1497.5 (m.i.), 1498.4 (av.)
Molecular Formula: C63H92IN11O23

Product Description

Enantiomeric pure labelling precursor for 68Ga-, 177Lu- and 225Ac-labelled PSMA I&T [1-4].

For use by qualified personnel only.

Quantity

Product No. 50009: 250 µg net peptide (lyophilisate, TFA salt)

Product No. 50107: 1000 µg net peptide (lyophilisate, TFA salt)

Packaging

2 mL ISO clear type I tubular glass vials (2R borosilicate clear glass vials type I);
13mm crimp neck;
Lyophilisation stoppers;
Flip-off seal.

Storage and Stability

Storage at -20°C (± 5 °C). Protect from light.

Short-term storage up to 10 days at higher temperatures <+25°C (± 2°C) does not affect product quality.

Certificates

Certificate of Analysis

Certificate of Compliance

TSE/BSE Statement on request

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

Literature

[1] Weineisen M. et al. 68Ga- and 177Lu-Labeled PSMA I&T: Optimization of a PSMA-Targeted Theranostic Concept and First Proof-of-Concept Human Studies. J Nucl Med, 2015, 56(8):1169-76.

[2] Fendler WP. et al. 68Ga-PSMA PET/CT: Joint EANM and SNMMI procedure guideline for prostate cancer imaging: version 1.0.Eur J Nucl Med Mol Imaging, 2017, 44(6):1014-1024.

[3] Kulkarni HR et al. PSMA-Based Radioligand Therapy for Metastatic Castration-Resistant Prostate Cancer: The Bad Berka Experience Since 2013. J Nucl Med. 2016, 57(Suppl 3):97S-104S.

[4] von Eyben FE. et al. Third-line treatment and 177Lu-PSMA radioligand therapy of metastatic castration-resistant prostate cancer: a systematic review. Eur J Nucl Med Mol Imaging, 2018, 45(3):496-508.