DOTA-TOC GMP

DOTA-TOC GMP Grade

Product name: DOTA-TOC (Acetate salt)

Precursor for radiometal-labelled DOTA-TOC

Targeting of the somatostatin receptors for imaging and therapy

Molecular weight: 1421.6 [g/mol]

Molecular formula: C65H92N14O18S2

DOTA-TOC (GMP Grade)

General Information

Product No.: 50200, 50201
Product name: DOTA-TOC (Acetate salt)
Synonyms: DOTATOC, Edotreotide, DOTA(0)-Phe(1)-Tyr(3))octreotide
Sequence: DOTA–D-Phe–Cys–Tyr–D-Trp–Lys–Thr–Cys–Thr(ol)(cyclo 2-7)
Molecular weight: 1421.6 [g/mol]
Molecular formula: C65H92N14O18S2
CAS No.:  204318-14-9


Product Description

Enantiomerically pure, chemical precursor for radiopharmaceutical preparations with [68Ga], [90Y], [177Lu] or [225Ac].
For use by qualified personnel only.

Quantity

Product No. 50200: 1000 µg net peptide (lyophilisate, acetate salt)
Product No. 50201:      50 µg net peptide (lyophilisate, acetate salt)

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 +40°C over a period of ≤ 3 days does not affect the purity of the chemical precursor.
However, elevated temperature might lead to a change in the appearance of the lyophilisate.

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] Akurathi, V. et al., cGMP Production of 68Ga-DOTATOC in various radio synthesizers for imaging NETs, J Nucl Med 2018, 59 (supplement 1), 405.

[2] Lapa, C. et al., Somatostatin receptor based PET/CT in patients with the suspicion of cardiac sarcoidosis: an initial comparison to cardiac MRI, Oncotarget 2016, 7(47), 77807–77814.

[3] Luna-Gutierrez, M. et al., Improving Overall Survival and Quality of Life in Patients with Prostate Cancer and Neuroendocrine Tumors Using 177Lu-iPSMA and 177Lu-DOTATOC: Experience after 905 Treatment Doses, Pharmaceutics 2023, 15(7), 1988.

[4] Zhi, Y. et al., Somatostatin Receptor–Directed PET/CT Can Differentiate Between Differetiate Subtypes of Head and Neck Paragangliomas, Clin Nucl Med 2023, 48(11), 923-927.